Tuesday, February 27, 2018
12:00 Noon – 1:30 pm EST
Instructor: Barry A. Friedman, Ph.D.
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 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.
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
$385 for one person
$700 2-5 people
$999 6-10 people
About the Instructor:
Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing arena. From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD. In that capacity as the Director, Quality Control, he managed a multi-shift Department of thirty one individuals involved in Client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity Dr. Friedman enjoyed many client and regulatory compliance interactions.
Dr. Friedman has over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness assistance, quality control, sterility assurance, microbiological/analytical validations and fermentation technology. In addition to the associations listed above, other associations have included Chesapeake Biological Laboratories, W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.
Dr. Friedman is a frequent seminar and webinar speaker and specializes in the areas of regulatory compliance, internal auditing, aseptic processing for sterile drug products, USP and Warning Letter “dissection”, multi-departmental interactions, 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, TungstenShield, Compliance OnLine, IPA (Canada) and Pharmig (UK). He maintains an active Blog (www.barryafriedmanphdllc.com) that contains over 200 Blogs that address various Warning Letter and FDA 483 issues. The Blog also contains over 1,500 “Search” terms to enable one to locate a particular regulatory action. He is a member of ASM, PDA and RAPs. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President and current Treasurer of the Capital Area Chapter, PDA. He recently received the James Agalloco award from PDA which is awarded to a PDA faculty member who exemplifies outstanding performance in education.