Overview:
Outsourcing serves as a catalyst for increased efficiency and access to specialized knowledge and resources that may be lacking within an organization. However, ambiguity often arises concerning the responsibilities and authority limits of the Owner/Marketing Authorization Holder (MAH)/Sponsor versus the entities performing the actual work when collaborating with Contract Development and Manufacturing Organizations (CDMOs) or contract laboratories.

This free webinar will cover:

• Recent inspection and audit findings
• April 2025 updates to the EMA’s GMP/GDP Inspectors Working Group Q&A
• FDA draft guidance on the use of outsourcing for drug compounding
• EMA Reflection Paper on GMP and the responsibilities of the MAH
• FDA Guidance on Quality Agreements

Presenter:
Karen Taylor (née Ginsbury) is a GMP and Quality Management Systems consultant with over 30 years of industry experience. She has supported both large and small start-up companies in regulatory inspection readiness, handling, and post-inspection responses. Having conducted hundreds of CDMO audits, Karen brings a wealth of case studies to share with participants. Formerly active in PDA, she co-founded and co-chaired the Outsourced Operations Interest Group, advocating strongly for best practices in outsourced operations.