CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers - Recorded Webinar

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Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Roger Cowan

OVERVIEW:
Control of suppliers such as Contract Manufacturing Organizations (CMO) has always been a requirement of the FDA and EU. With the issuance of these new regulatory documents the expectation is that there will be a written documentation of this control. Proof of this control can be presented to FDA / EU inspectors in the form of a Quality Agreement which is specific to a particular CMO. This webinar will provide a thorough understanding of the content that is expected in Quality Agreements from a regulatory perspective.

Each proposed section of a Quality Agreement is fully analyzed and suggested content is written with the new guidelines taken into consideration. Comparison of the two regulatory documents will be presented with differences highlighted and discussed. The latest status of the FDA draft guidance will be discussed and a review of comments from industry is included.

Why should you Attend: This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.

Areas Covered in the Session:
- The who and what of a good Quality Agreement
- What a Quality Agreement is - and is not
- Responsibilities of the owner vs. contract facility
- GMP responsibilities
- A comparison of the new guidelines from the FDA and the EU

Who Will Benefit:
- Quality Assurance
- External Manufacturing / Outsourcing
- Quality Auditing
- Technology Transfer
- Regulatory Affairs / Compliance
- Supply Chain
- Purchasing
- Risk Management

SPEAKER PROFILE:
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.

After your payment, we will contact you with instructions about how to access the webinar.
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