155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach
Description
On this episode, I was joined by Laurie Auerbach, President and Principal Consultant, Compliance Prodigies, LLC.
In this episode, Laurie dives into the complexities of FDA compliance programs, specifically focusing on combination product inspections and the 7356.000 Inspections of CDER-led or CDRH-led Combination Products compliance program.
Laurie discusses the definitions, scope, and expectations of combination product manufacturers, addressing the FDA's inspection types, regulatory requirements, and expectations.
Laurie also highlights common misconceptions, especially among contract manufacturers (CMOs) and the importance of proper audit and supplier management practices. Laurie shares insights and practical advice for ensuring compliance, emphasizing the gaps between drug and device regulations and how to effectively bridge them.
Chapters:
00:56 Understanding FDA Compliance Programs
02:33 Types of FDA Inspections
03:04 Mock Audits and Process Validation
03:45 Combination Product Manufacturer Definition
04:38 Inspection Guides and Compliance
06:47 Supplier Controls and Responsibilities
09:20 Challenges in Mock Pre-Approval Inspections
16:32 Supplier Management and Quality Agreements
24:19 Contract Manufacturers and Design Control
25:03 Conclusion
Laurie Auerbach is an industry consultant with over 20 years of experience in quality and regulatory compliance, serving in management and consulting roles for startup to major global manufacturers in the medical device, in vitro diagnostic, and combination product industries. Laurie conducts internal and supplier audits and mock pre-approval and post-approval inspections for compliance with ISO 13485, ISO 14971, §820, and §4, and EU MDD, IVDD, and EU MDR. She also conducts training for biopharmaceutical sponsors and device platform manufacturers on combination product regulatory requirements, including focused training on design control, risk management, CAPA, supplier controls, and inspection readiness. Laurie serves as Vice Chair of the ISPE Combination Products Community of Practice and is an active member of PDA, AAMI, RAPS, TOPRA, and DIA.
United States
