Combination Products Summit: Streamlining 21 CFR Part 4 Compliance


8:00 a.m. – 8:30 a.m.

Continental Breakfast

8:30 a.m. – 10:00 a.m.

Understanding 21 CFR 211 Laboratory Controls

  • Reserve sampling programs — are you practicing representative or insufficient retention?
  • The 3 W’s of expiration testing:  What studies do I need? When to do it? Why do I need to do it?
  • Testing and release — have you assured adequate specifications and criteria?
  • Stability testing and strategy
    • Is it simply a container/closure or is it part of the combination product?
    • Impact of sterilization on stability, expiration dating and labeling
  • Case Study:  Proven Methods for Choosing Specifications for Product Characterization and Stability

Dr. Dvorah Feder, Director, Analytical Chemistry Research & Technology, Abbott Vascular

Jie Hu, Manager, Material Characterization Lab and Bioanalytical Services, Abbott Vascular

10:00 a.m. – 10:15 a.m.


10:15 a.m. – 11:45 a.m.

Purchasing Controls — Quality Begins With Procurement

  • Purchasing Agreements — seven critical elements every quality agreement should address
  • Benefiting from your supplier’s quality system and documentation
  • Putting your Original Equipment Manufacturer (OEM) relationship to work — Leveraging OEM product data and design requirements
  • Understanding requirements for repackaging
  • Engaging qualified contractors and consultants — Effectively augmenting your workforce with experienced, reliable, and temporary staff  
  • Case Study: Making Effective Supplier Decisions — Using risk-based tools and decision-making to prioritize audits of contractors/suppliers based on criticality

Patti Gupta, President, Patti Gupta & Associates LL

11:45 a.m. – 12:45 p.m.


12:45 p.m. – 3:45 p.m.

CAPA and Nonconformances — FDA Shouldn’t Be the Only Investigators

  • A comprehensive approach to CAPA systems
  • Complaints, adverse events and medical device reporting — how to develop a common approach using yes/no decision tree process
  • What is CAPA appropriate? Determining appropriate decisions, documentation and investigations
  • Ensuring your non-conformance documentation conforms to requirements
  • Risk assessments — it’s not just for design controls
  • Root cause investigations — getting down to the real root of the matter
  • Tracking and trending — what your system is REALLY trying to tell you
  • What did I miss? Identifying and addressing areas that are often overlooked
  • Case Study:  Correction, Corrective Action and Preventive Action — Which is Needed?

Gary Gilliam, Operations and Quality Executive, MedPharm Consulting, Inc.
Patti Gupta, President, Patti Gupta & Associates LLC

3:45 p.m. – 4:00 p.m.


4:00 p.m. – 4:45 p.m.

Managing Quality From The Top Down — Sustaining Overall GMP Compliance

  • Audit strategy — managing internal and external regulatory authority audits
  • How best to present your Quality System program — starting out on the “right path”
  • Effective management controls from quality policy to CAPAs and audit execution — the checks and balances to ensure you’re maintaining compliance
  • 7 things every training program must address
  • Overlooked metrics that need your immediate consideration
  • Executing management reviews — managers don’t know what they don’t know
    • Don’t tell them what they want to hear, tell them how they can help
    • Understanding your data and its impact on product quality and patient safety

Dr. Mary C. Getz, Vice President, NSF Health Sciences-Medical Device Consulting

4:45 p.m. – 5:00 p.m.

Conclusions and Acknowledgements

Dr. Mary C. Getz, Vice President, NSF Health Sciences-Medical Device Consulting



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