Blog - Page 3 of 13 - Executive Conference Corporation Webinars

Risk Based Approach to Cleaning & Disinfection

Tuesday April 23, 2019
12:00 Noon – 1:30 pm EDT

Instructor: Jim Polarine

This seminar will cover the current industry regulations in the US, Europe and Globally related to cleaning and disinfection. Regulatory expectations will be covered including the latest revision of Annex I and recent FDA Warning Letters and 483’s related to cleaning and disinfection will be covered. The current antimicrobial products used in cleanroom industry will be discussed. Cleaning frequency, disinfectant rotation, rinsing and residue removal, disinfectant coverage calculations, and the most current equipment and methodologies for cleaning and discinfection will be covered in detail. The topic of sterility as it relates to cleanroom disinfectants and sporicides will be explained. This seminar will provide the audience with the ability to design and effective risk-based approach to cleaning and disinfection.

HVAC and GMP Environmental Control – for Pharmaceutical Clean Rooms

Tuesday April 30, 2019
1:00 pm – 2:00 pm EDT

Instructor: Roger Cowan

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.

Therefore, the design, validation and ongoing monitoring of a clean room HVAC system is necessary to assure the quality and safety of the pharmaceutical product.

Also, a proper understanding and testing of the clean room environment according to international regulatory standards is important from a compliance perspective.

It is important that a clean room’s HVAC system is fully understood, properly designed and properly validated. If this is accomplished, it will provide the environmental control necessary to meet the regulatory particulate and microorganism levels necessary to manufacture quality pharmaceutical product.

This webinar first details and explains the various US and international regulatory requirements for various clean room classifications.

Next, the webinar provides a comprehensive overview of the mechanics of clean room HVAC. This includes engineering diagrams and schematics. HVAC equipment components are detailed as well as the automated control systems that are available. Clean room design considerations are included. Proper building construction and layout is necessary to achieve both optimum efficiency of the system and optimum cleaning and sanitization of the clean room.

Cleaning and Cleaning Validation

Tuesday May 14, 2019
12:00 Noon – 1:30 pm EST

Instructor: Richard Forsyth

This Web Seminar will present a comprehensive overview of the life-cycle approach to cleaning for product contact surfaces of equipment in the pharmaceutical industry. The four phases of cleaning : cleaning assessment, cleaning development, cleaning validation and cleaning monitoring will be discussed including how they contribute to a compliant, evolving cleaning program.

The cleaning assessment phase evaluates either the current cleaning procedure or a proposed change to the current cleaning procedure against the current regulatory cleaning validation expectations. Any necessary remediation strategy for the assessment is determined in order to define an efficient cleaning development study.

Management of Out of Specification (OOS) and Out of Trend (OOT) Results from a Microbiological Perspective – The Impact of the FDA & ICH Regulations and Guidance

Wednesday May 15, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D.

Microbiological Out of Specifications may occur with the production of both non-sterile and sterile products. They may occur as early in the process as with In-coming Raw Materials and extend throughout In-process and Active Pharmaceutical Ingredient (API) phases to the final product.

With the advent of the revised USP<61> Microbial Examination of Nonsterile Products: Microbial Enumeration Test, a new latitude in result interpretation has come to the fore; however, one needs to understand how to utilize these inherent variations of USP<61> with Out of Trend (OOT) and Out Of Specification (OOS)

Microbial data deviations or non-conformances periodically may occur as well as OOT, OOS and Corrective and Preventive Actions (CAPA). However, unlike chemical analytical deviations, all microbial non-conformances to include OOS and CAPA investigations may require as many as six months to complete these studies based on their degree of difficulty and additional laboratory testing that may be required.

FDA’s Combination Products and Its Impact on Manufacturers of Pharmaceuticals, Biopharmaceuticals, Medical Devices and HCT/P – The Final Guidance, “Current Good Manufacturing Practice Requirements for Combination Products”

Thursday May 16, 2019
1:00 pm – 2:30 pm EDT

Instructor: Barry A. Friedman, Ph.D.

Historically, the absence of clear cGMP requirements for Combination Products has resulted in inconsistent application as to the applicable Agency Center to submit product for review. Products for both CDER and CDRH as the primary Agency contact point may have historically been submitted to the incorrect organization for review because of a lack of knowledge as to the Primary Mode of Action (PMOA) of the product. While some of these product applications might have been relatively easy to discern, e.g., a pre-filled syringe (usually CDER), other products may have had great difficulty finding the “correct home”.

Pre-Formulation and Formulation Development of Small and Large Molecules for a Lyophilized Product

Wednesday May 22, 2019
12:00 pm – 1:30 pm EST

Instructor: J. Jeff Schwegman, Ph.D.

Background:

This seminar will begin by covering ways to understand the physical properties of our formulated products through the use of very specialized analytical techniques. The information obtained from these specialized studies is critical in developing optimized lyophilization cycles and formulations without having to use a “trial and error” approached, which is still commonly used by many companies who don’t understand the science behind freeze-drying. Next, webinar will focus on using what was learned above to develop an optimized, cGMP compliant formulation that is specifically designed for lyophilization. In depth discussions will be included on a pre-formulation assessment, pre-formulation studies including choosing an optimal solution pH and buffer system, solubility enhancement, controlling oxidation, and bulking agents. Additionally, time will be dedicated to tying everything learned from the pre-formulation studies into designing an optimal formulation tailored specifically for our molecule of interest. Finally, the webinar will conclude with a discussion on the specialized aspects of designing a formulation for large, biomolecule formulations, and the analytical techniques used drive this process.

Good Laboratory Practices (GLP) vs. Good Manufacturing Practices (GMPs) — A Comparison and Contrast – “Why One Should Use Only GMP Facilities for Manufacturing and Testing”

Wednesday May 29, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D.

Periodically one hears the comment that “a laboratory or a manufacturing facility meets 21 CFR Part 58 Good Laboratory Practices (GLP) and therefore they meet all of the cGMP requirements”. Contrary to popular belief, 21 CFR Part 58 is not the equivalent of 21 CFR 210/211 and does not meet the same requirements as 210/211. They (Part 58) do have the force of law and are not “watered down” GMPs.

Good Manufacturing Practices (cGMPs) represents that part of Quality Assurance that ensures that products are consistently produced and controlled to the Quality standard appropriate to their intended use and as required by the product specification. They fall within the requirements of 21 CFR Parts 210/211 and support final product requirements for humans and animals.

Good Laboratory Practices Non-clinical laboratory studies (58.1) support or are intended to support application for research or marketing permits for the following products to include:

Cleanroom Microbiology for the Non-Microbiologist

Thursday May 30, 2019
1:00 pm – 2:30 pm EDT

Instructor: Barry A. Friedman, Ph.D.

Cleanroom microbiology is an area that has continued to grow over the last thirty years. It has moved from open ISO Class 5 cleanrooms with no isolation between the filling and stoppering to filling and stoppering in a completely enclosed environment where no human interaction occurs. It was not until the advent of USP<1116> and the FDA Guidance for Industry “Sterile Drug Products Produced By Aseptic Processing, 2004” that the requirements seriously began to gain a requirement “foothold” in the industry. It has moved from filling vials for antibiotics to filling pre-filled syringes. We have moved to the filling of recombinant proteins to the filling of gene and cell therapy products. Not only do we need to be concerned today with microbial contamination, but also with endotoxin concerns.

Sterile products may be broadly classified into two main categories based on their production mode — those that are terminally sterilized following the filling and sealing of the container and those that are aseptically sterilized, that is, filter sterilized as a bulk product, filled and then sealed. Aseptic processes play a critical role with large molecules that cannot be terminally sterilized. The verification of the process to produce sterile product is evaluated by the demonstration of various media fill process simulations that will vary in both numbers and size of the containers as well as the volumes filled over a defined period of time.

Antimicrobial Effectiveness and Its Testing

Tuesday June 4, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D.

Nonsterile dosage products often use preservatives in their formulations to minimize the growth of microorganisms inadvertently introduced during or subsequent to the manufacturing process. Sterile products packaged in multiple-dose containers contain antimicrobial preservatives to inhibit the growth of microorganisms that may be introduced from the repeated withdrawal of individual doses.

Antimicrobial preservatives should not be considered as a substitute for good manufacturing practices (GMP), solely to reduce the viable microbial population of a nonsterile product or control the presterilization bioburden of a multidose formulation during manufacturing.

Antimicrobial effectiveness, whether natural within the product or produced because of the addition of an antimicrobial preservative, must be demonstrated for all injections packaged in multiple-dose containers or for other products containing antimicrobial preservatives. Antimicrobial effectiveness must be demonstrated for aqueous-based, multiple-dose topical and oral dosage forms and for other dosage forms such as ophthalmic, otic, nasal, irrigation, and dialysis fluids.

Process Analytical Technology (PAT) vs Traditional Validation

Thursday June 13, 2019
12:00 pm – 1:30 pm EDT

Instructor: Nissan Cohen

Process Analytical Technology (PAT) was released to the pharmaceutical industry by the FDA in September 2004, almost 15 years ago. Why hasn’t the industry adopted en masse this excellent technology in lieu of traditional validation and operations? Why has the industry been reticent to adopt all of the “Guidelines for the 21st Century” as outlined by the FDA in 2004?

Find out how this technology has important implications for continuous manufacturing, continuous operations, 24/7 operations, production cost savings, validation savings, and regulatory scrutiny.

This presentation is informative and educational depicting the FDA’s incentives for adoption of this technology and program.

The Waiting Is Over – A New General Chapter, USP<60>, Burkholderia cepacia Is On The Horizon

Tuesday June 18, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D.

Burkholderia cepacia and its BCC Complex are bacterial species that are ubiquitous in nature and often found as a frequent recall issue based upon CDER data. Pharmaceutical products that are contaminated with B. cepacia and/or its Complex may pose serious issues to infants, elderly and immunocompromised individuals. Preventing B. cepacia contamination in drugs by addressing the potential sources of this bacterium in a drug manufacturing operation is an important public health goal.

Historically, when the USP was revised in May 2009, it was modified to include both USP<61> and USP<62>, and harmonized with both the European Union (EU) and Japanese Pharmacopeia (JP). B. cepacia was excluded at that time as a “specified” bacterium – even though many individuals believed that it should have been included. In addition, it was not included within USP<1111> when it also was modified several years ago. One of the main reasons that all believed that it should have been included was because of the frequency in which it occurs and the diversity of environments and products in which it has been found.

Debates and Challenges Concerning Disinfectant Validation and Methods to Circumvent Them

Wednesday June 12, 2019
12:00 Noon – 1:30 pm EST

Instructor: Jim Polarine

This presentation covers current debates in the industry regarding disinfectant coupon testing. PDA Technical Report No. 70 and USP 39 <1072> will be covered in relation to current industry disinfectant efficacy testing. Recent FDA Warning Letters and 483s will be covered that highlight regulator expectations in disinfectant efficacy testing. Data will be presented covering the importance of disinfectant efficacy testing with specific bacterial spores which can be more difficult to kill than ATCC strains. Both sides of the debate on disinfectant validation will be covered in detail with an emphasis on current FDA, MHRA, ANVISA, and HPRA regulatory expectations and reducing the costs for testing.

Monitoring of Bioburden – How to Manage and Control Contamination within Non-Sterile and Sterile Products

Wednesday June 19, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D.

Monitoring of in-process bioburden of pharmaceutical components, containers and closures, intermediates, drug substances and drug products is an essential element of the overall contamination control program for appropriate process control of both non-sterile and sterile products.

A typical bioburden control program includes review and analysis of potential sources of contamination commencing with each of the raw materials to include the Certificate of Acceptance of each. The microbiological contamination control program should be developed to identify and control bioburden and to assess product risk based on ICH Q9 Quality Risk Management. The bioburden risk assessment should result in the establishment of a range of critical control points which will ultimately lead to specifications for each raw material and to each unit operation as well as the drug substance (DS) and product (DP).

Pharmaceutical Compressed Air – Quality GMP Standards and Requirements

Tuesday June 25, 2019
1:00 pm – 2:00 pm EDT

Instructor: Roger Cowan

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.

The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product.

Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system.

Compressed air is often overlooked as a potential source of clean room and product contamination. This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system.

MICROBIOLOGY FOR THE NON-MICROBIOLOGIST — AND THE MICROBIOLOGIST WHO DESIRES A GMP MICROBIOLOGICAL REFRESHER

Wednesday June 26, 2019
1:00 pm – 2:30 pm EDT

Instructor: Barry A. Friedman, Ph.D

With the increasing number of Regulatory Actions throughout North America to include Form FDA 483s and Warning Letters for both Active Pharmaceutical Ingredients (APIs) and finished product, it has become increasingly important for Companies and individuals, in particular, manufacturing both non-sterile and sterile final products, to have a basic understanding of microbiology — regardless of the Department in which they work. Every individual within varying Departments from Facilities to Manufacturing to Quality Control should understand the basics of microbiology and the issues that non-compliance can create. Recently, a large multi-national pharmaceutical company was cited for the second time by the FDA for not determining that mold was growing on the “clean side” of the HEPA filters in an ISO Class 5 environment after it had been identified by mechanics several years previously.

Risk Management of Raw Materials in a GMP Environment

Tuesday July 16, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D

Risk management of raw materials in a cGMP environment is an area that is often overlooked as a Company develops new tablets and capsules vs. biotechnology products, as few as fifteen to twenty raw materials or as many as sixty need to be sourced and accepted before the process can be moved from initiation through completion. This live, interactive presentation will extensively review this area. It will also delve into the renewed issue of microbial and endotoxin contamination of these raw materials and why the FDA, EMA and Health Canada have recently focused on them.

This live, interactive training webinar will also examine a variety of the issues surrounding raw materials to include what materials should be tested and to what extent during Phase 1, 2 and 3. It will cover testing requirements during each Phase and what may be optional until the product moves to its next Phase. It will determine what options exist — even within a Phase 2 or Phase 3 testing framework. It will discuss compendial vs. non-compendial testing and how to respond when no method is available. The presentation will also discuss how a 90 percent vs. a 90.0 percent minimum purity analysis can delay your initiation of testing.

USP/FDA Microbiological Non-Compliance Issues in a Biopharmaceutical/Pharmaceutical Environment

Thursday July 18, 2019
1:00 pm – 2:30 pm EDT

Instructor: Barry A. Friedman, Ph.D

USP/FDA Microbiological Non-Compliance Issues often represent observed problems that occur with both non-sterile and sterile products in controlled and classified environments as well as within the microbiological laboratory. Various regulators will cite firms for these non-compliance issues under a variety of different sections of the Code of Federal Register (CFR) to include 21 CFR 211.113(a) and (b), 211.84(d)(6), 211.165(b), and 211.192. Non-compliance issues are also cited as per United States Pharmacopeia to include USP<51>, <61>, <62>, <71>, <1072>, <1111>, <1113>and <1116>. Also, various Guidances for Industry are also cited and often used within Observations. One of the most notable Guidances is the September 2004 FDA Guidance for Industry on Aseptic Processing.

Risk Based Approach to Cleaning & Disinfection

Tuesday July 23, 2019
12:00 Noon – 1:30 pm EDT

Instructor: Jim Polarine

This seminar will cover the current industry regulations in the US, Europe and Globally related to cleaning and disinfection. Regulatory expectations will be covered including the latest revision of Annex I and recent FDA Warning Letters and 483’s related to cleaning and disinfection will be covered. The current antimicrobial products used in cleanroom industry will be discussed. Cleaning frequency, disinfectant rotation, rinsing and residue removal, disinfectant coverage calculations, and the most current equipment and methodologies for cleaning and discinfection will be covered in detail. The topic of sterility as it relates to cleanroom disinfectants and sporicides will be explained. This seminar will provide the audience with the ability to design and effective risk-based approach to cleaning and disinfection.

The Microbiology of Water in a GMP Environment

Tuesday July 23, 2019
2:00 pm – 3:30 pm EDT

Instructor: Barry A. Friedman, Ph.D

Knowledge of the microbiology of water in a GMP environment is critical to the health of any water system being used to produce a pharmaceutical or biotechnology product. Even companies manufacturing tablets need to be aware of the quality of the water that may be contacting their process or product. The well-being of a facility revolves around the health of each water system within that facility. How often have we learned of a facility being closed for weeks at a time because of a water system that has exceeded its microbiological specifications?

This live, interactiveExecutive Conference Corp. (ECC) training webinar presentation will also examine a variety of the issues surrounding water in a facility to include the testing of each water source and to what extent. It will cover testing requirements during commissioning and testing on an on-going basis. The webinar will examine Quality Risk Management (ICH Q9) and discuss how a properly developed Facility Water Validation Plan may lead to a logical, reduced requirement for testing vs. time.

Annex 1: A European Guideline with Regulatory Enforcement

Thursday July 25, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D

Annex 1 is a European guidance document for Sterile Medicinal Products. Annex 1 was originally devised in the early 2000s and is currently under revision. The topics and subjects of Annex 1 are extensive defining all aspects of Sterile Medical products processing, manufacture, and critical utilities used. These subjects include barrier technology, cleanroom classifications and qualification, water systems, disinfection, steam for sterilization, compressed gases, cooling systems, terminally sterilized products, aseptic preparation, different aspects of sterilization, closed and single use systems.

Process Analytical Technology (PAT) vs Traditional Validation

Thursday July 25, 2019
12:00 pm – 1:30 pm EDT

Instructor: Nissan Cohen

Process Analytical Technology (PAT) was released to the pharmaceutical industry by the FDA in September 2004, almost 15 years ago. Why hasn’t the industry adopted en masse this excellent technology in lieu of traditional validation and operations? Why has the industry been reticent to adopt all of the “Guidelines for the 21st Century” as outlined by the FDA in 2004?

Find out how this technology has important implications for continuous manufacturing, continuous operations, 24/7 operations, production cost savings, validation savings, and regulatory scrutiny.

This presentation is informative and educational depicting the FDA’s incentives for adoption of this technology and program.

Process Simulation Testing for Aseptically Filled Products; An In-depth Examination of the Latest Product Sterility Assurance Levels Prescribed by GMPs

Tuesday July 30, 2019
1:00 pm – 2:30 pm EDT

Instructor: Barry A. Friedman, Ph.D

Sterile products may be broadly classified into two main categories based on their production mode — those that are terminally sterilized following the filling and sealing of the container and those that are aseptically sterilized, that is, filter sterilized as a bulk product, filled and then sealed. Aseptic processes play a critical role with large molecules that cannot be terminally sterilized. The verification of the process to produce sterile product is evaluated by the demonstration of various media fill process simulations that will vary in both numbers and size of the containers as well as the volumes filled over a defined period of time.

Products that have historically been aseptically filled have relied upon the use of USP <71> Sterility Tests to demonstrate sterility. However, since no more than 20 containers are tested per media regardless of the production lot size, the use of sterility tests does not provide a high degree of sterility assurance (SAL). Thus, media fills are now utilized to simulate the actual fills and to demonstrate at least a 10^-3 sterility assurance level of no contamination. If the facility uses RABS or isolators, a SAL of 10^-5 to 10^-6 is even possible since the interactions with personnel and the environment decrease markedly.

CMO Supplier Quality Agreements – How to Comply with new FDA and EU Guidelines for Contract Drug Manufacture

Thursday August 8, 2019
1:00 pm – 2:00 pm EDT

Instructor: Roger Cowan

In 2010, the global CMO market was estimated at $26 billion dollars. Year on year growth has been 10.7% since 2008. The increasing use of outsourcing in the pharmaceutical industry along with recent well publicized quality issues with CMOs, make it a necessity to have excellent quality oversight of external manufacturers to provide assurance of GMP compliance. A Quality Agreement is one tool used to accomplish this objective.

A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety and efficacy of the manufactured drug.

Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts:

EU GMP Chapter 7 “Outsourced Activities” (Revised)
Guidance for Industry “Contract Manufacturing Arrangements for Drugs: QualityAgreements”

THE BACTERIAL ENDOTOXINS TEST (ISSUES AND SOLUTIONS) — TO INCLUDE THE ISSUE OF LOW ENDOTOXIN RECOVERY (LER) AND TR 82 (PDA)

Tuesday August 13, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D

On Tuesday, July 12, 2011, the FDA posted on their web site a notice that they had withdrawn the 1987 Guideline on Validation of the Limulus Amebocyte Lysate Test as an End Product Endotoxin Test for Human Parenteral Drugs, Biological Products and Medical Devices. They advised that the 1987 Guideline is considered obsolete and does not reflect the Agency’s current thinking on the topic.

In lieu of this document, the FDA advised that they would be issuing a Guidance for Industry on Pyrogen and Endotoxins Testing: Questions and Answers during the November/ December 2011 timeframe. After much delay, this NEW Guidance was released in June 2012.

In addition, the FDA references three documents that they believe have more than offset the previous FDA Guidance that was withdrawn. They advise that these documents be referenced for the fundamental principles of the gel clot, photometric and kinetic test methods.

This new, revised Questions and Answers Guidance supplements the above three documents and addresses those issues that may be subject to misinterpretation, not covered in compendial procedures or in the previously available Guidance document.

Understanding and Troubleshooting Pharmaceutical Water Systems

Thursday August 15, 2019
12:00 pm – 1:30 pm EDT

Instructor: Nissan Cohen

“Understanding and Troubleshooting Pharmaceutical Water Systems” is a comprehensive presentation on the depiction and assessment of different water purification modules used in pharmaceutical water systems. This presentation explains the design requirements, usage, and reasoning for the institution of a given process module in the pharmaceutical water system producing Purified or WFI waters.

There are many permutations and selection alternatives for pharmaceutical process modules to attain regulatory compliance to USP or regulatory mandated water quality. This presentation outlines alternatives and options allowing for increased flexibility in choosing the correct modules to produce Purified Water (PW) or Water for Injection (WFI) final product waters.

Regulatory Aspects of Microbiology in a Non-Sterile Environment

Tuesday August 20, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D

Non-sterile microbiology offers many challenging regulatory issues often not considered in aseptic manufacturing because the rules have historically been minimal when compared to aseptic manufacturing. These rules have included the handling and evaluation of non-sterile components, the environment and final product, but not to the extent of sterile products.

This 90 minute Executive Conference Corp.(ECC) webinar discusses various regulations and requirements and how they impact non-sterile manufacturing to include the setting of specification, development of the process, holding times, preservation issues, cleaning, sanitization and the requirements for the testing of recovered microorganisms. Water Activity, which was out of vogue until recently, will also be reviewed. The “Art of Troubleshooting, Finding What Occurred”, will also be highlighted

GMPs for MICROBIOLOGISTS — The Manufacturing Environment

Wednesday August 21, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D

Executive Conference Corporation (ECC) is proud to present GMPs for Microbiologists, The Manufacturing Environment.Within a Manufacturing Environment, cGMP microbiological issues always arise that require addressing.

Whether the facility is considered to be a Controlled or Classified environment, whether it is manufacturing non-sterile or aseptically filled product, the Microbiology Environment of the product is critical to assuring products leave the facility with the microbiology specifications in control. As the facility is examined in additional detail, the environment also must be considered. Both airborne viable and non-viable particulate considerations must be explored and controlled within all areas from ISO 5 to 8. The water systems, which include potable water, purified water and water for injection, will also be explored regarding their specifications, maintenance, and compliance.

Contamination Control Strategies: Facts and Sciences to Consider

Thursday August 22, 2019
12:00 Noon – 1:30 pm EDT

Instructor: Jim Polarine

This webinar will cover a risk-based approach to a cleaning and disinfection program and case studies in contamination control. Details will be provided on how to follow a risk-based approach for cleaning and disinfection using good science. The most common causes of contamination will be conveyed in case studies with fungal spore, bacterial spore, and Deinococcuscontamination. Solutions will be discussed on how to proactively prevent contamination from reoccurring.

Risk Management of Data Integrity To Include FDA, WHO and EMA’s Latest Guidances for Industry

Thursday August 29, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D

Data Integrity has become a non-compliance area often observed by the FDA and reported within Form FDA 483s and Warning Letters. While various governments have observed this on a world-wide basis, the FDA has been reporting its occurrence off-shore with a greater frequency than usually observed within the United States.A lack of Data Integrity hints of a Company being outside of compliance and questions the quality of the product being produced.

Often the initial “hint” of an off-shore problem occurs within FDA “circles” when one first observes an “Import Alert”. These Import Alerts don’t offer much information other than the country, the Company and the product. However, this becomes a tell-tale signal that a Warning Letter will most likely be issuing within three to four months.

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Tuesday September 10, 2019
1:00 pm – 2:00 pm EDT

Instructor: Roger Cowan

Environmental Monitoring looks at the end results of the Environmental Control program – the microbiological and particulate quality of the clean room.

As the FDA Guideline on Aseptic Processing GMP (2004) states:

“In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing environment (e.g., when a given batch is being manufactured) as well as environmental trends of ancillary clean areas. Environmental monitoring should promptly identify potential routes of contamination, allowing for implementation of corrections before product contamination occurs.”

The Waiting Is Over – A New General Chapter,USP<60>,Burkholderia cepacias On The Horizon (December 2019 to issue)

Thursday September 12, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D

Burkholderia cepaciaand its BCC Complexare bacterial species that are ubiquitous in nature and often found as a frequent recall issue based upon CDER data. Pharmaceutical products that are contaminated with B. cepaciaand/or its Complexmay pose serious issues to infants, elderly and immunocompromised individuals. Preventing B. cepacia contamination in drugs by addressing the potential sources of this bacterium in a drug manufacturing operation is an important public health goal.

Historically, when the USP was revised in May 2009, it was modified to include both USP<61> and USP<62>, and harmonized with both the European Union (EU) and Japanese Pharmacopeia (JP). B. cepacia was excluded at that time as a “specified” bacterium – even though many individuals believed that it should have been included. In addition, it was not included within USP<1111> when it also was modified several years ago. One of the main reasons that all believed that it should have been included was because of the frequency in which it occurs and the diversity of environments and products in which it has been found.

Microbial Data Deviation Investigations — Latest FDA & ICH Requirements and Guidance

Tuesday September 17, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D

Microbial data deviation investigations come in a multiplicity of forms and may vary from the very simple to include the incubation of a plate at an incorrect temperature to attempting to determine the “root cause” of a sterility test failure. The resultant investigations and their data requirements may be very short in duration, e.g., a matter of only several to 40 – 50 hours. However, unlike chemical analytical deviations and their Out Of Specification (OOS) studies and Corrective/Preventive Action (CAPA) programs, the length of time to complete these microbiological investigation studies may extend to as many as six months based on the biological laboratory studies that may be required.

The question often arises as why my Company is experiencing these deviations? Very often the answer is simple laboratory errors that require minimal training to correct. In other situations personnel are experiencing difficulties with understanding the USP or the standard operating instructions (SOPs) from which these SOPs are derived. In still other situations, these problems are being caused by management, and personnel require their assistance to minimize these complex periodic issues.

Best Practices for Cleaning Validation Swab Sampling and Recovery Studies

Thursday September 19, 2019
12:00 Noon – 1:30 pm EDT

Instructor: Richard Forsyth

This Web Seminar will present a detailed overview of best practices for cleaning validation swab recovery and sampling for Active Pharmaceutical Ingredients (APIs) and detergents from product contact surfaces of equipment in the pharmaceutical industry. All aspects of swab sampling will be discussed with the emphasis on how swab sampling ties into the cleaning validation program.

Current regulatory expectations and how they impact swab recovery and sampling will be reviewed. Of note will be the expectations for acceptable recovery studies and concerns for instances of low recoveries.

The swab parameter phase evaluates the parameters necessary to clearly demonstrate that a swab sampling will accurately and consistently provide data that demonstrates a cleaning validation study is successful. The swab parameters are evaluated individually to assess their impact on swab data. The calculated cleaning limit directly impacts the swab parameters to be validated.

DEVELOPING THE KEY ELEMENTS OF A PROCESS VALIDATION PLAN

Tuesday September 24, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D

Whether a Company is developing a new product or facility, the issue of developing the key elements of a comprehensive Validation Package is essential to assure the timely completion of all activities. A Validation Package is designed to satisfy both current domestic and international regulations, guidelines and policies for active pharmaceutical ingredients (APIs), drugs (FP), biologics and devices and to verify equipment systems, utilities, software and processes are properly designed (DQ), installed (IQ), operate (OQ) and perform (PQ) in a consistent and controlled manner.

The purpose of validation is to assure the facility, manufacturing process, and supporting services are capable of supporting the manufacture of pharmaceutical and device products that consistently meet their predetermined quality attributes. The Validation Master Plan (VMP) uses a “life cycle” approach and emphasizes Quality Risk Management (ICH Q9) as the Plan proceeds from validation through verification and qualification. The VMP is intended to project a picture of how your company has integrated current Good Manufacturing Processes (cGMP) as promulgated in 21 CFR Part 820 and 211 into all aspects of the manufacturing process.The Validation Program is designed to proactively assure GMP compliance from facility development through the distribution of final product.

Best Practices for Cleaning Validation Swab Sampling and Recovery Studies

Wednesday March 20, 2019
12:00 Noon – 1:30 pm EDT

Instructor: Richard Forsyth

This Web Seminar will present a detailed overview of best practices for cleaning validation swab recovery and sampling for Active Pharmaceutical Ingredients (APIs) and detergents from product contact surfaces of equipment in the pharmaceutical industry. All aspects of swab sampling will be discussed with the emphasis on how swab sampling ties into the cleaning validation program.

Current regulatory expectations and how they impact swab recovery and sampling will be reviewed. Of note will be the expectations for acceptable recovery studies and concerns for instances of low recoveries.

The swab parameter phase evaluates the parameters necessary to clearly demonstrate that a swab sampling will accurately and consistently provide data that demonstrates a cleaning validation study is successful. The swab parameters are evaluated individually to assess their impact on swab data. The calculated cleaning limit directly impacts the swab parameters to be validated.

Pharmaceutical Compressed Air – Quality GMP Standards and Requirements

Thursday October 3, 2019
1:00 pm – 2:00 pm EDT

Instructor: Roger Cowan

Environmental Monitoring looks at the end results of the Environmental Control program – the microbiological and particulate quality of the clean room.

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.

The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product.

Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system.

Compressed air is often overlooked as a potential source of clean room and product contamination. This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system.

Antimicrobial Effectiveness (USP<51>)and Its Testing

Tuesday October 8, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D

Nonsterile dosage products often use preservatives in their formulations to minimize the growth of microorganisms inadvertently introduced during or subsequent to the manufacturing process. Sterile products packaged in multiple-dose containers contain antimicrobial preservatives to inhibit the growth of microorganisms that may be introduced from the repeated withdrawal of individual doses.

Antimicrobial preservatives should not be considered as a substitute for good manufacturing practices (GMP), solely to reduce the viable microbial population of a nonsterile product or control the presterilization bioburden of a multidose formulation during manufacturing.

Good Laboratory Practices (GLP) vs. Good Manufacturing Practices (GMPs)– A Comparison and Contrast– “Why One Should Use Only GMP Facilities for Manufacturing and Testing”

Thursday October 10, 2019
1:00 pm – 2:30 pm EDT

Instructor: Barry A. Friedman, Ph.D

Periodically one hears the comment that “a laboratory or a manufacturing facility meets 21 CFR Part 58 Good Laboratory Practices (GLP) and therefore they meet all of the cGMP requirements”. Contrary to popular belief, 21 CFR Part 58 is not the equivalent of 21 CFR 210/211 and does not meet the same requirements as 210/211. They (Part 58) do have the force of law and are not “watered down” GMPs.

Good Manufacturing Practices (cGMPs) represents that part of Quality Assurance that ensures that products are consistently produced and controlled to the Quality standard appropriate to their intended use and as required by the product specification. They fall within the requirements of 21 CFR Parts 210/211 and support final product requirements for humans and animals.

Development of a Steam Autoclave Sterilization Validation Plan

Tuesday October 15, 2019
1:00 pm – 2:30 pm EDT

Instructor: Barry A. Friedman, Ph.D

Terminal moist heat sterilization is presently considered the method of choice to ensure sterility. All aqueous-based sterile products are subject to terminal moist heat sterilization unless the sterilization, itself, will degrade the product. This interactive, live Executive Conference Corp. (ECC) webinar is intended to provide manufacturers of pharmaceutical dosage forms as well as components (vials and stoppers) with guidance to establish the scientific effectiveness of moist heat sterilization processes. It has been developed as an overview of the elements of moist heat sterilization processes requiring evaluation, and describes approaches to effectively accomplish this.

This guideline, derived from Health Canada guidances, specifies the minimum documentation required to certify that moist heat sterilization processes have been thoroughly evaluated and are adequately controlled and validated.

EMA’s New 2019 Guideline on Sterilization of Medicinal Products and its Potential Impact on FDA’s Sterilization Thinking

Wednesday October 16, 2019
1:00 pm – 2:30 pm EDT

Instructor: Barry A. Friedman, Ph.D

The European Medicines Agency (EMA) recently published “Sterilization of the Medicinal Product, Active Substance, Excipient and Primary Container” in March 2019 which has an effective date of October 2019. This new Guidance should have a dramatic impact on the FDA’s sterilization thinking since it strongly suggests that there are alternatives, i.e., Advanced Therapy Medicinal Products (ATMPs), to standard terminal sterilization standards of 121^oC for 15 minutes.

This new guidance discusses the choice of selective methods of sterilization of sterile products. It also reviews the use of terminal sterilization and the importance of alternative methods for manufacturing sterile products when terminal sterilization will cause degradation. Where terminal sterilization is not possible, an alternative must be developed that includes the rationale of ICH Q9 – Quality Risk Management. For new products, the guidance provides the appropriate decision-making process within several tables for the sterilization of various final product forms, e.g., aqueous, powder, pellets. Again, Quality Risk Management and its elements are essential to the decision-making process.

Monitoring of Bioburden – How to Manage and Control Contamination within Non-Sterile and Sterile Products

Thursday October 17, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D

Monitoring of in-process bioburden of pharmaceutical components, containers and closures, intermediates, drug substances and drug products is an essential element of the overall contamination control program for appropriate process control of both non-sterile and sterile products.

A typical bioburden control program includes review and analysis of potential sources of contamination commencing with each of the raw materials to include the Certificate of Acceptance of each. The microbiological contamination control program should be developed to identify and control bioburden and to assess product risk based on ICH Q9 Quality Risk Management. The bioburden risk assessment should result in the establishment of a range of critical control points which will ultimately lead to specifications for each raw material and to each unit operation as well as the drug substance (DS) and product (DP).

Cleaning and Cleaning Validation

Tuesday October 22, 2019
12:00 Noon – 1:30 pm EST

Instructor: Richard Forsyth

This Web Seminar will present a comprehensive overview of the life-cycle approach to cleaning for product contact surfaces of equipment in the pharmaceutical industry. The four phases of cleaning : cleaning assessment, cleaning development, cleaning validation and cleaning monitoring will be discussed including how they contribute to a compliant, evolving cleaning program.

The cleaning assessment phase evaluates either the current cleaning procedure or a proposed change to the current cleaning procedure against the current regulatory cleaning validation expectations. Any necessary remediation strategy for the assessment is determined in order to define an efficient cleaning development study.

HVAC and GMP Environmental Control – for Pharmaceutical Clean Rooms

Tuesday November 5, 2019
1:00 pm – 2:00 pm EST

Instructor: Roger Cowan

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.

Therefore, the design, validation and ongoing monitoring of a clean room HVAC system is necessary to assure the quality and safety of the pharmaceutical product.

Also, a proper understanding and testing of the clean room environment according to international regulatory standards is important from a compliance perspective.

It is important that a clean room’s HVAC system is fully understood, properly designed and properly validated. If this is accomplished, it will provide the environmental control necessary to meet the regulatory particulate and microorganism levels necessary to manufacture quality pharmaceutical product.

Grouping Products and Equipment for Cleaning Validation and Selection of Worst-Case Parameters for Efficient Cleaning Validation Execution

Wednesday November 6, 2019
12:00 Noon – 1:30 pm EST

Instructor: Richard Forsyth

This Web Seminar will present a comprehensive overview of the product grouping and equipment grouping for cleaning validation (CV) for product contact surfaces of equipment in the pharmaceutical industry. Grouping of products and equipment are necessary in a multi-product facility to develop a comprehensive, understandable, executable and maintainable cleaning validation program.

Product grouping is used to identify the product(s) for CV execution. The selection criteria are critical to justify a defendable product grouping. Although a number of criteria are available, the two recommended criteria to use are: hardest-to-clean product and the product with the lowest cleaning limit.

The hardest-to-clean criterion is based on the physical properties of the formulation components and the proportion of each component in the formulation. In an aqueous or detergent based cleaning medium, hydrophilic, water soluble components are relatively easy to clean, whereas hydrophobic formulation components are more difficult to clean.

Process Simulation Testing for Aseptically Filled Products; An In-depth Examination of the Latest Product Sterility Assurance Levels Prescribed by GMPs

Thursday November 7, 2019
12:00 pm – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D

Sterile products may be broadly classified into two main categories based on their production mode — those that are terminally sterilized following the filling and sealing of the container and those that are aseptically sterilized, that is, filter sterilized as a bulk product, filled and then sealed. Aseptic processes play a critical role with large molecules that cannot be terminally sterilized. The verification of the process to produce sterile product is evaluated by the demonstration of various media fill process simulations that will vary in both numbers and size of the containers as well as the volumes filled over a defined period of time.

Products that have historically been aseptically filled have relied upon the use of USP <71> Sterility Tests to demonstrate sterility. However, since no more than 20 containers are tested per media regardless of the production lot size, the use of sterility tests does not provide a high degree of sterility assurance (SAL). Thus, media fills are now utilized to simulate the actual fills and to demonstrate at least a 10^-3 sterility assurance level of no contamination. If the facility uses RABS or isolators, a SAL of 10^-5 to 10^-6 is even possible since the interactions with personnel and the environment decrease markedly.

Media fills are required during the commissioning of an aseptic operation within a new facility, when a new container configuration (volume or neck size) or other unique activities associated with aseptic filling occurs. Following the on-going performance of a new aseptic filling line, a requalification is required at six month intervals.

Risk Factors Involved in the Development and Implementation of an Environmental Monitoring Strategy for a Controlled/Classified Environment

Tuesday November 12, 2019
12:00 pm – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D

Environmental monitoring of controlled and classified environments and their systems is required to maintain compliance with EMA/FDA/Health Canada requirements. To perform this task, knowledge of the fundamentals of the systems and their requirements is a must. Doing this requires the ability to identify the “key” elements of the Monitoring Program. Understanding the regulations and the regulatory expectations must be accomplished to assure that all of the necessary SOPs, appropriate specifications and testing are developed, implemented and met. Relying on obtaining from others that a procedure must be executed in a specific way to “meet industry standards” or “meet industry expectations” leads only to disastrous consequences. Learning what documents form the foundation is required for the knowledge base.

The necessary regulatory documents must be in place and translated into the various SOPs. Both non-sterile and sterile production facilities must possess these documents. Significant source documents include ISO 14644, Annex 1 (revised March 2009), FDA’s Aseptic Processing Guidance document (September 2004), USP 1116 (revised May 2012), etc.

Debates and Challenges Concerning Disinfectant Validation and Methods to Circumvent Them

Wednesday November 13, 2019
12:00 Noon – 1:00 pm EST

Instructor: Jim Polarine

This presentation covers current debates in the industry regarding disinfectant coupon testing. PDA Technical Report No. 70 and USP 39 <1072> will be covered in relation to current industry disinfectant efficacy testing. Recent FDA Warning Letters and 483s will be covered that highlight regulator expectations in disinfectant efficacy testing. Data will be presented covering the importance of disinfectant efficacy testing with specific bacterial spores which can be more difficult to kill than ATCC strains. Both sides of the debate on disinfectant validation will be covered in detail with an emphasis on current FDA, MHRA, ANVISA, and HPRA regulatory expectations and reducing the costs for testing.

Cleanroom Microbiology for the Non-Microbiologist

Thursday November 14, 2019
12:00 pm – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D

Cleanroom microbiology is an area that has continued to grow over the last thirty years. It has moved from open ISO Class 5 cleanrooms with no dividers between the filling and stoppering to filling and stoppering in a completely enclosed environment where no human interaction occurs (isolators). It was not until the advent of USP<1116> and the FDA Guidance for Industry on Aseptic Processes (2004) that the requirements seriously began to gain a requirement “foothold” in the industry. It has moved from filling vials for antibiotics to filling pre-filled syringes. The industry has moved to the filling of recombinant proteins and gene and cell therapy products. Not only do we need to be concerned with microbial contamination, but also more so today with endotoxin concerns.

Sterile products may be broadly classified into two main categories based on their production mode — those that are terminally sterilized following the filling and sealing of the container and those that are aseptically sterilized, that is, filter sterilized as a bulk product, filled and then sealed. Aseptic processes play a critical role with large molecules that cannot be terminally sterilized. The verification of the process to produce sterile product is evaluated by the demonstration of various media fill process simulations that will vary in both numbers and size of the containers as well as the volumes filled over a defined period of time.

The Waiting Is Over – A New General Chapter, USP<60>, Burkholderia cepacia Is On The Horizon (December 2019 to issue)

Tuesday November 19, 2019
12:00 pm – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D

Burkholderia cepacia and its BCC Complex are bacterial species that are ubiquitous in nature and often found as a frequent recall issue based upon CDER data. Pharmaceutical products that are contaminated with B. cepacia and/or its Complex may pose serious issues to infants, elderly and immunocompromised individuals. Preventing B. cepacia contamination in drugs by addressing the potential sources of this bacterium in a drug manufacturing operation is an important public health goal.

Historically, when the USP was revised in May 2009, it was modified to include both USP<61> and USP<62>, and harmonized with both the European Union (EU) and Japanese Pharmacopeia (JP). B. cepacia was excluded at that time as a “specified” bacterium – even though many individuals believed that it should have been included. In addition, it was not included within USP<1111> when it also was modified several years ago. One of the main reasons that all believed that it should have been included was because of the frequency in which it occurs and the diversity of environments and products in which it has been found.

Combination Products Regulatory Expectations and the FDA’s Latest Codification of the Applicable cGMP Requirements

Tuesday December 3, 2019
12:00 pm – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D

Historically, the absence of clear cGMP requirements for Combination Products has resulted in inconsistent application as to the applicable Agency Center to submit product for review. Products for both CDER and CDRH as the primary Agency contact point may have historically been submitted to the incorrect organization for review because of a lack of knowledge as to the Primary Mode of Action (PMOA) of the product. While some of these product applications might have been relatively easy to discern, e.g., a
pre-filled syringe (usually CDER), other products may have had great difficulty finding the “correct home”.