FDAnews Announces Six FDA Officials to Speak at Combination Products Summit: Streamlining 21 CFR Part 4 Compliance, Nov. 9-10, 2015 · Bethesda, MD

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The regulatory landscape for combination products is more complicated than drug and device products alone and raises unique challenges that affect the entire product lifecycle. Contradicting terminologies, SOPs, GDPs, timelines and budgets, quality control, postmarket modifications and safety concerns make for serious challenges.

Combination Products Summit:
Streamlining 21 CFR Part 4 Compliance
**Presented by FDAnews and NSF Health Sciences**
Nov. 9-10, 2015 – Bethesda, MD

FDAnews is pleased to announce the addition of five FDA officials to the roster of speakers for the Combination Products Summit: Streamlining 21 CFR Part 4 Compliance taking place Nov 9-10, 2015 in Bethesda, MD.

  •     John (Barr) Weiner, Associate Director for Policy and Product Classification Officer, Office of Combination Products, 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
  •     Francisco Vicenty, Mechanical Engineer, Division of Analysis and Program Operations, CDRH, FDA
  •     Jay Jariwala, CSO, Combination Product Expert, OC, CDER, FDA

They will be joined by former Director of the Office of Compliance, CDRH, FDA, Tim Ulatowski as well as the following industry experts:

  •     Dr. Mary C. Getz, Vice President, NSF Health Sciences-Medical Device Consulting
  •     Patti Gupta, President, Patti Gupta & Associates LLC
  •     Elaine Messa, President, NSF Health Sciences, Medical Device Consulting
  •     Olivia Wong, Director, NSF Health Sciences, Medical Device Consulting
  •     Amit Khanolkar, Director, Combination Products & Emerging Technologies PQM, Johnson & Johnson Janssen Pharmaceuticals
  •     Dr. Dvorah (Debby) Feder, Director, Analytical Chemistry Research & Technology, Abbott Vascular
  •     Jie Hu, Manager, Material Characterization Lab and Bioanalytical Services, Abbott Vascular
  •     John Karels, Principal, Project Solutions Consultants
  •     Christy Skinner, Quality Assurance, W.L. Gore and Associates
  •     Gary Gilliam, Operations and Quality Executive, MedPharm Consulting, Inc.

This hands-on workshop will show attendees how to develop effective GMP approaches and how to execute them. Attendees will work hand-in-hand with instructors and fellow attendees on comprehensive exercises that will take them from theory to practical application including:

  •     How to develop integrated cGMPs and regulatory strategies for Combination Products
  •     How — and when — to implement 21 CFR 820 requirements for design controls, and how to develop a strategy for legacy products
  •     How to apply 21 CFR 211 requirements for product release, retains, sterility, and stability
  •     Tested ways to present and justify exemptions or compliance to specific regulations, including human factors and product release testing
  •     How to set a quality and regulatory strategy for a combination product portfolio
  •     Important nuances, such as when a container or closure becomes a combination product
  •     How to leverage quality agreements to support compliance to 21 CFR Part 4

To ensure a better understanding of some of the most important issues involved with Combination Product cGMPs, the expert faculty will present detailed case studies featuring interactive leader-participant exercises:

Case Study 1: Understanding PMOA before the Product is DOA.

Case Study 2: Proven Methods for Choosing Specifications for Product Characterization and Stability.

Case Study 3 : Making Effective Supplier Decisions — Using Risk-based Tools and Decision-making to Prioritize Contractor/Supplier Audits.

Case Study 4: Correction, Corrective Action, and Preventive Action — Which Is Needed?

In addition, attendees receive an absolutely invaluable workshop folder and USB drive with scores of supporting, need-to-have tools and reference documents.

It's not hard to see: There's no other conference even remotely at the level of Combination Products Summit: Streamlining 21 CFR Part 4 Compliance.

Who Will Benefit:
●    Engineering managers
●    Quality engineers
●    Analytical Chemists
●    Compliance Managers – Training and Internal Audit oversight
●    Purchasing and supply chain managers
●    Procurement agents involved in outsourcing production or processes
●    R&D staff – Engineering, and Analytical Lab personnel
●    Medical staff evaluating risk, safety, or effectiveness
●    Regulatory affairs managers
●    General/corporate counsel
●    Directors and managers responsible for delivery and execution to 21 CFR Part 4 requirements
●    Those involved with the day-to-day activities of combination product design, development, validation and production within quality, regulatory, laboratories, engineering, R&D and operations organizations

Conference Details
Combination Products Summit:
Streamlining 21 CFR Part 4 Compliance
**Presented by FDAnews and NSF Health Sciences**
Nov. 9-10, 2015 – Bethesda, MD

Tuition: $1,797
Significant team discounts are available.

Easy Ways to Register
Online: http://www.fdanews.com/comboproducts
By phone: 888-838-5578 or 703-538-7600

About FDAnews
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
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