Combination Products Summit: Streamlining 21 CFR Part 4 Compliance


7:00 a.m. – 8:00 a.m.

Registration and Continental Breakfast

8:00 a.m. – 8:30 a.m.


8:30 a.m. – 9:15 a.m.

FDA’s Expectations for Combination Products Manufacturers — Review of 21 CFR Part 4 Requirements

  • How current regulations and guidances define a combination product
  • Why the FDA created its final rule and draft companion guidance and what it means for the industry
  • Understanding the roles and responsibilities of FDA Centers and Office of Regulatory Affairs

John (Barr) Weiner, Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA

9:15 a.m. – 10:30 a.m.

FDA and Industry Interactions; Cultivating a Relationship of Transparency

  • Communicating with the FDA — a proactive approach to developing a compliant quality system everyone can agree with
  • Top 10 best business practices and lessons learned
  • Presenting data to justify compliance — or exemptions — to the regulators (contact points, human factors, product release testing, reserve sampling and testing)
  • Your combination product portfolio — how to set a quality and regulatory strategy
  • You have options — how to balance the right approach for your company
  • Planning and prioritizing product/process remediation
  • Understanding and managing risk — ensuring a safe, effective and risk-based approach
  • Incorporating appropriate quality elements in a sustainable manner

Christy Skinner, Quality Assurance, W.L. Gore and Associates
Michelle Garrett, Operations Manager, NSF International Health Sciences, Medical Devices


10:30 a.m. – 10:45 a.m.


10:45 a.m. – 12:15 p.m.

FDA and Industry — Expert Panel Discussion — Things That Keep You Up at Night

  • Challenges for the industry — how one can approach developing a combination product strategy
  • Proactive vs Reactive — if no one has been cited — why do we have to do it?
  • Are there other new requirements or guidance that Industry can use as a basis for developing a compliance strategy?
  • How do I develop a working relationship when I don’t know even know where to start the dialog?

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

John (Barr) Weiner, Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA
Jay Jariwala, CSO, Combination Product Expert, OC, CDER, FDA
Christy Skinner, Quality Assurance, W.L. Gore and Associates
Francisco Vicenty, Mechanical Engineer, Division of Analysis and Program Operations, CDRH, FDA
Dinesh Kumar, Regulatory Counsel, Office of Orphan Products Development, Office of Policy and Risk Management, ORA, FDA
Edward Patten, Associate Director Manufacturing Science, Office of Medical Products and Tobacco, Office of Compliance and Biologics Quality, CBER, FDA
Melissa Burns, Senior Program Manager, Office of Combination Products, FDA

12:15 p.m. – 1:15 p.m.


1:15 p.m. – 4:30 p.m.

How and When to Implement 21 CFR 820.30 Design Controls

  • I’m pharma — why do I need to care about a design and development plan or design verifications?
  • I’m device — what do I need to know about containers/closures, yield calculations and expiration dating?
  • Top 3 things to know about biocompatibility
  • Why do I need to do design validation and process validation?
  • Are legacy products grandfathered in?
  • Do’s and Don’ts of evaluating risk documentation for compliance
  • Why do I need to worry about design control if I use off-the-shelf or 510(k) components?

Case Study: Understanding PMOA Before Your Product is DOA

Olivia Wong, Director, NSF Health Sciences, Medical Device Consulting
Amit Khanolkar, Director, Combination Products & Emerging Technologies PQM, Johnson & Johnson Janssen Pharmaceuticals
John Karels, Principal, Project Solutions Consultants


4:30 p.m. – 6:30 p.m.

Networking Social



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