Quality Agreements (Final Guidance, Nov. 2016): Purpose, Scope, Organization, Common Issues & A Comprehensive Review of the 2019 FDA Regulatory Requirements
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>
Available Live On-Demand
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 training webinar is to obtain an enhanced understanding of this “Contract Arrangement for Drugs: Quality Agreement” (Final Version, November 2016), and to assure that Companies are engaging in compliant drug manufacturing. A review of Case Studies/ Warning Letters pertinent to both the contracted facility as well as the Product owner that involve both the laboratory and microbiological issues will also be presented to enhance this webinar.
-Understand the Definition of a Quality Agreement
-Understand the Purpose 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
-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
Webinar outline and time breakdown:
|10:15 AM||Log In Period|
|10:40 AM||Understand the Purpose, Scope and Organization of a Quality Agreement,|
|Learn how to Develop a Quality Agreement to Assure that Each Party Understands and Accepts the Critical Elements,|
|10:40 AM||Observe several Hypothetical Scenarios and the Common Problems that occur within Contracted Manufacturing Arrangements,|
|A Review of Pertinent Case Studies/Warning Letters where Quality Agreements are Responsible for Data Integrity in Laboratory Records and Test Results,|
|The Impact of Quality Agreements Upon Microbiological Issues within the Laboratory,|
|12:30 PM||Live Questions & Discussion|
*Please note all times are Eastern Time (New York Time)
This live training webinar includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of training for attendee records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Quality Assurance personnel
- Quality Control personnel
- Research & Development
- Regulatory Affairs Professionals
- Those that use contract manufacturing and contract testing facilities
- Microbiology Professionals
- Project Managers
Instructor: Barry A. Friedman Ph.D.
Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>
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