CMO Supplier Quality Agreements – How to Comply with New FDA and EU Guidelines for Contract Drug Manufacture Recorded Webinar | Roger Cowan | From: Nov 04, 2020 - To: Dec 31, 2020 |
A contract between a GMP Contract Manufacturer and a pharmaceutical firm is a Quality Agreement and it details the responsibilities of both parties by assuring the safety, efficacy, and quality of the drug that has been manufactured. Recently FDA and the EU issued regulatory guidance which aims in bringing out some consistency as well as clarity to some quality contracts such as:
The global contract manufacturing organization (CMO) market in 2010 was estimated to be at $26 billion, increasing by 10.7% since 2008. This increased outsourcing in the pharma industry as well as recent quality issues with CMOs that have been well-publicized, has brought out the importance and need for having an excellent quality oversight into external manufacturers so that GMP compliance is assured. Quality Agreement will be used as a tool to accomplish this objective.
To control CMOs and other such suppliers has always been a requirement of the FDA and EU. Issuing this new regulatory documentation has fueled an exception that this control will have written documentation and proof of the control can be presented to EU/FDA inspectors as Quality Agreements specific to particular CMO.
Areas Covered in the Session:-
Why You Should Attend?
This session is aimed at providing a clear understanding of the content expected in Quality Agreements from a regulatory perspective. Roger will fully analyze each section of the proposed Quality Agreement suggest appropriate content each while taking into consideration the new guidelines. The webinar will also provide a comparison of both the regulatory documents and highlight and discuss the differences.
We will get into the details of the quality agreement, including change control, documentation, facilities, and equipment, lab controls, sub-contracting, etc. Lastly, he will provide insight on the latest status of FDA draft guidance and review comments from the industry.
Who Will Benefit:-
Roger Cowan is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 37 years experience in pharmaceutical quality assurance and manufacturing. In his career, Roger has held various manager / director positions in Quality Assurance, QC Laboratory, Technical Services Validation, Manufacturing, and Clinical Supply manufacturing and distribution. Roger has taught courses in microbiology at Seneca College (Pharmaceutical Technology Program) in Toronto, Canada.
Roger's areas of expertise include: aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US / International regulatory requirements, regulatory submissions, and quality assurance/control.
