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. Come find out how at this session featuring an FDA speaker who can provide details on the latest developments and answer your questions.


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!


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.


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 align staff by FDA product. The goal is to increase efficiency and transparency in inspections and regulatory decision-making. CDER also has set a goal of communicating the final inspection classification within 90 days of the end of the inspection. One year in, come hear how the program is working and how the FDA and the inspected facilities are reacting to the changes.


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.


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.

CDRH’s New Initiatives and Priorities for 2019: How it will Impact Your Company

This is not your father’s CDRH. There’s more emphasis on global activities and a greater expectation of transparency and data security. You’ll hear the acting director of compliance discuss and answer questions about these important issues:

  • The new inspection approach/strategy for medical devices in 2018-2019 and its practical impact on your business
  • PMA Critical to Quality Pilot
  • Case for Quality Voluntary Program
  • Medical Device Single Audit Program

12:00 p.m. – 12:45 p.m.

FDA Investigator Insights

This presentation will give you a glimpse into the inner workings of an investigator’s mindset before, during and after your inspections. You’ll learn what they experience and how you can avoid some of the common mistakes they see all the time.


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.


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


12:00 p.m. – 12:45 p.m.

Best Practices in Clinical Trial Inspection Readiness

We all know it is best to stay prepared for an inspection, but this task requires a lot of work and can be a daunting experience. This session focuses on the essential steps you must take to be ready for your next inspection. For example, what warning will you receive from the FDA? Why are certain facilities chosen? What do inspectors typically focus on? What are the most common missteps clinical sites make? What are your rights during the inspection? How do you respond to an inspection finding? Come to this session to reduce your anxiety and sleep well knowing your facility is ready for whatever comes!


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.


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.


5:00 p.m. – 6:30 p.m.

Networking Reception


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