13th Annual FDA Inspections Summit

8:00 a.m. – 9:00 a.m. Registration and Continental Breakfast
9:00 a.m. – 9:10 a.m. Opening Comments by Chairperson
9:10 a.m. – 10:00 a.m. Integrated Quality Assessment and the FDA’s Move to Align Review and Inspections Staff
10:00 a.m. – 10:45 a.m. Good Supply Practices (GSPs) for the Lifesciences
10:45 a.m. – 11:00 a.m. Refreshment Break
11:00 a.m. – 3:15 p.m. Three Concurrent Breakout Tracks
12:45 p.m. – 1:45 p.m. Lunch
3:15 p.m. – 3:30 p.m. Refreshment Break
3:30 p.m. – 5:00 p.m. The FDA’s Vision and Strategy for Field Programs
5:00 p.m. – 6:30 p.m. Networking Reception

Drugs & Biologics Track

11:00 a.m. – 11:10 a.m. Moderator Comments
11:10 a.m. – 12:00 p.m. The US/EU Mutual Recognition of Drug GMP Inspections
12:00 p.m. – 12:45 p.m. The FDA’s New Approach to Drug Inspections
12:45 p.m. – 1:45 p.m. Lunch
1:45 p.m. – 3:15 p.m. Panel Discussion: Global Data Integrity
3:15 p.m. – 3:30 p.m. Refreshment Break

Medical Device Track

11:00 a.m. – 11:10 a.m. Moderator Comments
11:10 a.m. – 12:00 p.m. CDRH’s New Initiatives and Priorities for 2019: How it will Impact Your Company
12:00 p.m. – 12:45 p.m. FDA Investigator Insights
12:45 p.m. – 1:45 p.m. Lunch
1:45 p.m. – 3:15 p.m. Panel Discussion: MDSAP Audit Experience
3:15 p.m. – 3:30 p.m. Refreshment Break

Clinical Trials Track

11:00 a.m. – 11:10 a.m. Moderator Comments
11:10 a.m. – 12:00 p.m. BIMO Update
12:00 p.m. – 12:45 p.m. Best Practices in Clinical Trial Inspection Readiness
12:45 p.m. – 1:45 p.m. Lunch
1:45 p.m. – 3:15 p.m. Panel Discussion: The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site
3:15 p.m. – 3:30 p.m. Refreshment Break

8:00 a.m. – 9:00 a.m.

Registration and Continental Breakfast


9:00 a.m. – 9:10 a.m.

Opening Comments by Chairperson

Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding, former FDA Deputy Associate Commissioner for Regulatory Operations


9:10 a.m. – 10:00 a.m.

Integrated Quality Assessment and the FDA’s Move to Align Review and Inspections Staff

The FDA is continuing to move toward the use of “Integrated Quality Assessment” teams. This new, team-based approach is meant to foster greater communication and alignment between field and review staff so that the agency can make closer consideration of all elements that create risk, including the drug substance, the drug product, manufacturing processes, and the state of the facilities. For drug manufacturers, it’s called a “concept of operations,” for medical device manufacturers, it’s called “Total Product Lifecycle Quality.” Either way, the agency is changing how it manages product quality, and you need to change with it.

 


10:00 a.m. – 10:45 a.m.

Good Supply Practices (GSPs) for the Lifesciences

The FDA and industry professionals have collaboratively worked through Xavier University to develop Good Supply Practices for the 21st Century that increase the success of your product through an intentionally developed supply chain. The team identified one major paradigm shift and three new concepts that result in a step jump improvement in how you develop and manage your supply chain. Don’t miss this opportunity to set your organization up for patient, product and business success!

Marla A. Phillips, Ph.D., Director, Xavier Health, Xavier University; former Head of Quality at Merck’s North Carolina facility


10:45 a.m. – 11:00 a.m.

Refreshment Break


11:00 a.m. – 3:15 p.m.

Three Concurrent Breakout Tracks

  • Track 1 — Drugs & Biologics
  • Track 2 — Medical Devices
  • Track 3 — Clinical Trials

Drugs & Biologics Track

11:00 a.m. – 11:10 a.m.

Moderator Comments

Susan Schniepp, Distinguished Fellow, Regulatory Compliance Associates, Inc.


11:10 a.m. – 12:00 p.m.

The US/EU Mutual Recognition of Drug GMP Inspections

In March, the US and European Union signed a mutual recognition agreement (MRA) to recognize each other’s drug GMP inspections. This is good news for the industry that should see fewer inspections. However, it doesn’t come without some concerns. First, each inspection now has greater consequences as any problem will now be a red flag for multiple agencies. Also, if regulatory agencies share information, what does that mean for information confidentiality? Plus, the EMA retained authority to conduct inspections in “extraordinary circumstances,” but what does that mean, exactly? The FDA has until November to assess regulatory authorities in eight EU countries to trigger the start of the implementation of the agreement. How close are they? The agreement doesn’t mean European GMP regulations are less important — in fact, they are as important as ever. Come hear experts describe the practical implications of this agreement for drug GMP inspections so you’re not caught off guard.

Ellen Morrison, Associate Commissioner, OMPTO, ORA, FDA


12:00 p.m. – 12:45 p.m.

The FDA’s New Approach to Drug Inspections

Last fall, the CDER Office of Compliance began their Concept of Operations program — an initiative undertaken with the Office of Regulatory Affairs to increase efficiency and transparency in GMP drug inspections and regulatory decision-making. The Con-Ops program builds upon FDA’s recent Program Alignment by commodity. CDER also has set a goal of communicating the final inspection classification within 90 days of the end of certain GMP inspection. One year in, come hear how the program is working and how the FDA and the inspected facilities are reacting to the changes.

Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health


12:45 p.m. – 1:45 p.m.

Lunch


1:45 p.m. – 3:15 p.m.

Panel Discussion: Global Data Integrity

Data integrity has always been important during inspections, but as international agencies have worked to recognize each other’s inspections, global standards of data integrity have become more important. Multiple FDA warning letters and EU GMP non-compliance reports have highlighted major data integrity failures and falsification in companies globally. In addition, data integrity issues have become more complex for today’s manufacturers, as they learn to manage greater use of information technology, increased availability of international data, evolving regulations around the electronic technologies and models built on global drug development and manufacturing. This expert panel will provide context for the latest developments, describe how drug manufacturers have responded and provide clues for where international regulators will be looking for at your facility.

Moderator: Sue Schniepp, Distinguished Fellow, Regulatory Compliance Associates, Inc.

Kalah Auchincloss, J.D., Senior Vice President, Regulatory Compliance and Deputy General Counsel, Greenleaf Health

Ronald Tetzlaff, PhD, Corporate Vice President, PAREXEL Consulting

John Avellanet, Managing Director and Principal, Cerulean Associates LLC


3:15 p.m. – 3:30 p.m.

Refreshment Break


Medical Device Track

11:00 a.m. – 11:10 a.m.

Moderator Comments

Robert Ruff, Executive Director of Medical Device Education and Training, International MDSAP Team Lead, NSF Health Sciences; former Medical Device Specialist and Senior Investigator at ORA and International Team Lead at CDRH, FDA


11:10 a.m. – 12:00 p.m.

Getting to Root Cause During Your CAPA Investigation

Under the FDA’s risk-based requirements, every company doing business in the medical products industry, including suppliers, must have a corrective and preventive action (CAPA) program. The most essential component of a CAPA program is a documented system for discovering the root cause of system failures, nonconformances, product complaints and inspection findings.

Attendees will receive step-by-step guidance on conducting an effective root cause analysis, from recognizing problems that need to be investigated to documenting the investigation so regulators can see you are on top of the situation.

Karl Vahey, Vice President Manufacturing Quality, Cardinal Health


12:00 p.m. – 12:45 p.m.

The MDSAP Process

The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

Brian Ludovico, Executive Director, MDSAP Regulatory Certification, NSF Health Sciences


12:45 p.m. – 1:45 p.m.

Lunch


1:45 p.m. – 3:15 p.m.

Panel Discussion: MDSAP Audit Experience

If you’ve made a commitment to be certified through the Medical Device Single Audit Program, you certainly want to be ready for the audit. But let’s not forget that this can be a new experience for the auditors, too. Canada is the first market to require the MDSAP audit as part of its medical device licensing scheme, beginning Jan. 1, 2019, so you can bet others will soon follow. What can medical device manufacturers expect during the audit? How do you demonstrate that your staff is appropriate trained? How can you identify possible gaps in your readiness? This expert panel will describe what an MDSAP audit is like, and what lessons everyone can learn to be ready.

Moderator: Robert Ruff, Executive Director of Medical Device Education and Training, NSF Health Sciences; former Medical Device Specialist and Senior Investigator at ORA and International Team Lead at CDRH, FDA

Marc-Henri Winter, Staff Fellow, Division of International Compliance Operations, OC, CDRH, FDA

Alexander Crosby, Americas Program Manager, Medical Business Assurance, Intertek

Maura Corcoran, Senior Director, Quality Operations, Ethicon Wound Closure Repair (JnJ)

Karl Vahey, Vice President Manufacturing Quality, Cardinal Health

Brian Ludovico, Executive Director, MDSAP Regulatory Certification, NSF Health Sciences


3:15 p.m. – 3:30 p.m.

Refreshment Break


Clinical Trials Track

11:00 a.m. – 11:10 a.m.

Moderator Comments

David Borasky, Vice President IRB Compliance, WIRB-Copernicus Group


11:10 a.m. – 12:00 p.m.

BIMO Update

Hear the latest news and initiatives coming out of the Office of Bioresearch Monitoring Operations

David Glasgow, Deputy Director, Office of Bioresearch Monitoring Operations, OMPTO, ORA, FDA


12:00 p.m. – 12:45 p.m.

Using Metrics to Achieve Inspectional Readiness

Performance metrics and risk indicators should be an integral part of your inspection readiness program. Come to this session to explore:

  • Typical mistakes organizations make when selecting metrics
  • Measurement considerations when implementing risk-based quality management programs
  • Data organizations review in centralized monitoring programs
  • Trial Master File metrics that help organizations build and maintain inspection ready TMFs

Linda Sullivan, Executive Director, Metrics Champion Consortium


12:45 p.m. – 1:45 p.m.

Lunch


1:45 p.m. – 3:15 p.m.

Panel Discussion: The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site

The behavior of your staff during an inspection runs from supremely professional to downright comical. There are the stories of crack teams of QA/RA professionals who have every document and every answer an investigator needs, and then there are stories of firms that foolishly refuse to let the investigator into the plant. This panel takes the best and worst of the industry’s performance and combines it into one great lesson for you and your staff. This year’s panelists have seen it all and are here to give you the “skinny” on how to pass your upcoming inspection with flying colors.

Moderator: David Borasky, Vice President IRB Compliance, WIRB-Copernicus Group

David Glasgow, Deputy Director, Office of Bioresearch Monitoring Operations, OMPTO, ORA, FDA

Phillip Leese, President, Medical Consultants PA

Cassandra Kennedy, VP, Global Head, Regulatory Compliance and Quality Assurance, Covance


3:15 p.m. – 3:30 p.m.

Refreshment Break


Plenary Session Panel Discussion

3:30 p.m. – 5:00 p.m.

The FDA’s Vision and Strategy for Field Programs

The FDA’s field operations are going through a major overhaul. With the reorganization and program alignment, how will this affect your dealings with FDA staff? Hear from representatives from the Office of Medical Device and Radiological Health Operations, the Office of Pharmaceutical Quality Operations and the Office of Bioresearch Monitoring Operations to get the latest developments.

Moderator: Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding, former FDA Deputy Associate Commissioner for Regulatory Operations

Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, ORA, FDA (Invited)

David Glasgow, Deputy Director, Office of Bioresearch Monitoring Operations, OMPTO, ORA, FDA


5:00 p.m. – 6:30 p.m.

Networking Reception


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