Webinar Details:

Has your Company ever been in a situation where you find that a process requires Qualification, or an assay requires Validation and you and your Client do not have a clear understanding as to whom who should be paying for it? And, as a result, you and your Client come to a stalemate and nothing is done? And, to make matters worse, the FDA shortly arrives thereafter and cites both you and your Client for this non-compliance? Through your participation in this webinar, you should arrive at an understanding of how to manage these situations and avoid the citations from which these situations arise by gaining an enhanced understanding of “Written Quality Agreements”.

Written Quality Agreements are not explicitly required under existing CGMP regulations and do not relieve either party of their responsibilities under CGMP regulations or under the FD&C Act 501(a)(2)(B). However, Owners and Contracted Facilities can draw on quality management principles to initiate the complicated process of contract drug manufacturing by defining, establishing, and documenting the responsibilities of all parties involved in drug manufacturing, testing, or other support operations. Accordingly, FDA recommends that Owners and Contracted Facilities implement written Quality Agreements as a tool to delineate responsibilities and assure the quality, safety, and effectiveness of drug products.

The legal framework for Quality Agreements includes:

501(a)(2)(B): A drug is adulterated if…methods used in, or facilities or controls used for, manufacturing, processing, packing, or holding do not conform with CGMP.

In addition, the relatively new FDASIA includes a section which involves CGMPs and the role played by both the Owner and the Contracted Facilities. FDASIA § 711 “CGMP” includes “the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products”. It explicitly links CGMP to quality management activities. Several ICH documents also speak to Quality Agreements and include ICH Q7, Q9 and Q10.

Quality Agreements also outline critical roles played by both Product Owners and Contracted Facilities and explains how manufacturers should use Quality Agreements to define, establish, and document their responsibilities. It emphasizes that Quality Agreements should define parties’ responsibilities, assure full CGMP conformance, and facilitate consistent delivery of safe and effective medicines.

“Owner” and “Contracted Facility” are deliberate choices within the terminology of the Quality Agreement. A Quality Agreement is a comprehensive written document which defines and establishes obligations and responsibilities of Quality Units of parties involved in contract manufacturing of drugs subject to CGMP. The terms “Supply Agreement” or “Technical Agreement” or other possibilities are specifically excluded.

The objective of this live, interactive Executive Conference Corporation webinar is to obtain an enhanced understanding of this FDA Guidance for Industry “Contract Arrangement for Drugs: Quality Agreement”, and to assure that Companies are engaging in compliant drug manufacturing. A review of Case Studies/Warning Letters (see December 2019/January 2020) pertinent to both the contracted facility as well as the Product owner that involve the laboratory and microbiological issues will also be presented to enhance this webinar. Please bring a multidisciplinary group to this webinar to enhance everyone’s understanding.

By attending you will learn:

• About the NEW FDA Guidance for Industry “Contract Arrangement for Drugs: Quality Agreement”
• Understand the Definition of a Quality Agreement
• Learn about the Legal Framework behind Quality Agreements
• Learn what the Regulations are that Support Quality Agreements
• Learn What is and What is not Covered within the Scope of a Quality Agreement
• Understand the Purpose of a Quality Agreement
• Observe Several Hypothetical Scenarios and the Common Problems that Occur within Contracted Manufacturing Arrangements
• Learn how Quality Agreements are Responsible for Data Integrity in Laboratory Records and Test Results
• Learn how Quality Agreements Impact Microbiological Issues within the Laboratory

Who should attend:

• Project Managers
• Quality Assurance
• Sales
• Marketing
• Quality Control
• Manufacturing
• Validation

Fee:
$385 for one person
$700 2-5 people
$999 6-10 people