13th Annual FDA Inspections Summit

12:00 p.m. – 1:00 p.m. Registration
1:00 p.m. – 5:00 p.m. Flawless FDA Inspection Handling and Response
1:00 p.m. – 5:00 p.m. Preparing Your Team for EU-MDR
1:00 p.m. – 5:00 p.m. ICH E6 (R2) How to Build a Sponsor Risk Management Program

12:00 p.m. – 1:00 p.m.


Drugs & Biologics Preconference Workshop

1:00 p.m. – 5:00 p.m.

Flawless FDA Inspection Handling and Response

Rated #1 Pre-Conference Workshop in Inspection Summit History
Updated for FDA’s New Inspection Techniques!

Compliance pros know that getting an FDA investigator in and out as quickly as possible is the best strategy. The longer an FDA investigator is on site, the more likely you’ll be handed a multi-page 483.

In this popular session featuring John Avellanet of Cerulean Associates — one of the industry’s top inspectional readiness experts — you’ll learn how to prepare for an inspection, how to encourage the investigator to see you in a “state-of-control,” and how — if the worst happens — to manage a 483 observation and not get a warning letter.

Plus, John will explain how the FDA’s New Inspection Protocol Project inspection technique has already tripped up companies with good compliance records. He’ll go through the details related to how an organization that had years of clean inspections can suddenly find itself blind-sided based on NIPP. No one charged with managing FDA inspections can afford to miss this session!

Attendees will learn:

  • The critical inspection preparation techniques every member of your team must commit to memory — especially useful for those surprise FDA visits
  • Tactics that FDA investigators use to test your controls and are taught to probe your answers for weakness
  • How to speed the inspection to minimize the risk of 483 observations, while always remaining respectful
  • Tips for what really needs to be in your inspections SOPs, how to cut corporate-speak and unnecessary verbiage in your SOPs that doesn’t help, and how shorter SOPs are better
  • How to write an inspection response designed to reduce the likelihood of a warning letter — and tips and tricks to get sign-offs quickly from even the toughest groups (like legal)
  • What FDA staff look for in your replies and the top red flags they notice

Attendees will receive:

  • A sample regulatory inspection-handling SOP — ready for your immediate implementation
  • Three inspection-handling and response checklists — ready for you to use right away
  • An observation-closure matrix — ready to speed you out of FDA trouble

John Avellanet, Managing Director and Principal, Cerulean Associates LLC

Medical Devices Preconference Workshop

1:00 p.m. – 5:00 p.m.

Preparing Your Team for EU-MDR

The deadline for the EU-MDR is fast approaching; the Date of Application is May 26, 2020. Many device manufacturers focused on ISO 13485:2016 and preparing for an MDSAP audit. As a result, there had been limited capacity for EU-MDR planning and implementation. Now is the time.

The EU-MDR is a long and complex regulation with many interlocking parts. Articles refer to other articles and to annexes. Annexes use information from other annexes to develop plans and reports that, in some cases, are embedded in other plans or reports. This pre-conference workshop provides the overarching organization allowing you to identify and connect the pieces for your implementation.

The first component is the manufacturer’s infrastructure. This includes extensive requirements for the Quality Management System, QMS. There are nearly 15 necessary elements, many of which are not fully covered by ISO 13485:2016. The infrastructure includes relationships with other economic operators as well as many new requirements for the Authorized Representative.

The second component is the device. The classification system changed, so your device may have a device class that is not the same as in the MDD. Annex I General Safety and Performance Requirements, is significantly expanded from the MDD Annex I and includes both new requirements and revised existing requirements. In addition, the Annex II and Annex III Technical Documentation is more complicated. While the EU anticipates harmonized standards, there are none yet. There is a plan to create Common Specifications, but none have been issued.

The third component is the Notified Body, NB. Any potential NB must apply for EU-MDR because notifications for the MDD will expire. The EU-MDR has extensive requirements for the NB’s audit of a device manufacturer. You need to understand these requirements to prepare for the initial and surveillance audits.

Participants will learn:

  • The necessary elements in the QMS and some information about each one
  • Why ISO 13485:2016 is not adequate for the EU-MDR
  • The required elements in the QMS application to the Notified Body
  • The qualifications and responsibilities for the Person Responsible for Regulatory Compliance
  • The relationship with the other economic operators
  • The role of the Annex I requirements
  • The role of the Annex II and Annex III Technical Documentation
  • The EU-MDR UDI system
  • The required PMS reports based on device class and other characteristics
  • How the NB assesses the manufacturer’s quality system
  • How the NB conducts product verification
  • How the NB performs pre-clinical and clinical evaluation
  • How the NB performs surveillance activities and post-certification monitoring

Customized, Interactive and Full Of Valuable Take-Aways,
This Pre-Conference Workshop is a Must Attend

Dan O’Leary, President, Ombu Enterprises, LLC

Clinical Trials Preconference Workshop

1:00 p.m. – 5:00 p.m.

ICH E6 (R2) How to Build a Sponsor Risk Management Program

ICH E6 has changed the landscape for clinical trial professionals. The guidelines now require trial sponsors to institute risk assessment at both the system and clinical trial levels. Have you established your program yet? Is your maintenance program complete? This workshop is built to help you understand the requirements and put you on the road to full compliance long before the issue comes up during an inspection.

Prepare to discover:

  • What the new guidelines require
  • How to establish your program step-by-step
  • Critical elements of starting your program: A walk-through
  • How to conduct risk assessment at both system and clinical trial levels
  • Evaluating the risks: Your options
  • Risk mitigation and reporting strategies
  • Common pitfalls and how to sidestep them
  • And much more!

Your leader, Dr. Susan Leister, Vice-President of Quality & Compliance, Technical Resources International, boasts 20-plus years of industry experience and holds CQA and CSSBB certifications from the American Society for Quality. She serves on the ASQ Section 509 Executive Committee and served as a 2012 and 2013 Maryland Performance Excellence Award Examiner and a 2013 ASQ International Team Excellence Award Judge. She has served as a part-time faculty member of the University of Phoenix Undergraduate and Graduate School of Business for the past five years.

Customized, Interactive and Full Of Valuable Take-Aways,
This Pre-Conference Workshop is a Must Attend

Susan Leister, Vice-President of Quality & Compliance, Technical Resources International



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