VALIDATION MASTER PLANNING (DEVELOPING A COMPREHENSIVE VALIDATION PACKAGE)
Wednesday May 22, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Barry A. Friedman, Ph.D
Whether a Company is developing a new product or facility, the issue 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, 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.
Effective Batch Record Review
Thursday May 23, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Danielle DeLucy
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.
Developing a Holistic Disinfectant Validation and Efficacy Testing Program
Tuesday June 4, 2024
12:00 Noon – 1:30 pm (NY Time)
Instructor: Jim Polarine
Abstract:
This presentation covers current debates and challenges in the industry regarding disinfectant coupon testing and disinfectant field trials. Annex I (2022), PDA Technical Report No. 70, IEST RP 018.5, and USP 43 <1072> will be covered in relation to current industry disinfectant efficacy testing and disinfectant field trials. 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.
SOLVING STATISTICAL MYSTERIES – WHAT DOES THE FDA WANT?
Wednesday June 5, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Ronald D. Snee, PhD
Use of statistics has been part of the FDA’s guidances and regulations for many years. Use of statistics is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many. This presentation provides an overview of what it appears the FDA is looking for in the use statistics including examples and recommended approaches.
CAPA/Root Cause Analysis: Achieving Compliance with Proper CAPA Systems
Thursday June 6, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Danielle DeLucy
Course Description: This webinar will include discussions proper CAPA system maintenance, root cause analysis, documentation of the Corrective and Preventative Actions and developing a robust CAPA plan. It will give tips on how to develop CAPAs pertaining to longer term projects and ensure they stay on track.
Course Outline:
Definition of a CAPA:
- When a CAPA is needed
- Development of the essential pieces of a robust CAPA plan
Risk Management of Raw Materials in a GMP Environment
Tuesday June 11, 2024
12:00 pm – 1:30 pm (NY Time)
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 products. Depending on the product being developed, e.g., 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.
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 June 13, 2024
12:00 pm – 1:30 pm (NY Time)
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.
Bioburden Control of Non-Sterile Drug Substances and Products– A New USP General Information Chapter
Wednesday June 19, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Barry A. Friedman, Ph.D
USP recently released a “General Information Chapter” describing bioburden control of non-sterile drug substances and products — a much anticipated area that has gained significant attention over the past half dozen years. The subject, “USP <1115> Bioburden Control of Nonsterile Drug Substances and Products”, has generated much controversy as non-sterile manufacturers have repeatedly asked the question “what degree of microbial cleanliness should I require with my non-sterile drug substances and products” and “how many microorganisms of a single genus may I have where USP<1111> has limits of either 100 or 1000 per gram”? Efforts have been made to historically answer these questions within other USP Chapters to include USP<61>, USP<1111> and USP<1231> which have addressed both test methodologies and microbial counts allowed. 21 CFR 211 has also “weighed into” this fray with their various regulations but have not offered solutions. Quite often during lectures and seminars, the comment is overheard “With sterile products, it was so much simpler to provide a microbial answer because I have definitive endpoints”.
Proper Execution of Annual Product Reviews
Thursday June 20, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Danielle DeLucy
Key Takeaway:
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.
Overview:
Annual Product Quality Review (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change in the specifications of the product or any change in the manufacturing process.
HVAC and GMP Environmental Control – for Pharmaceutical Clean Rooms
Tuesday June 25, 2024
1:00 pm – 2:30 pm (NY Time)
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.
Process Simulation Testing for Aseptically Filled Products; An In-depth Examination of the Latest Product Sterility Assurance Levels Prescribed by GMPs
Wednesday June 26, 2024
12:00 pm – 1:30 pm (NY Time)
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.