FDAnews Announces the 14th Annual FDA Inspections Summit, Oct. 23-25, 2019, Bethesda, MD

FALLS CHURCH, Va., August 08, 2019 /PRNewswire-PRWeb/ -- 14h Annual FDA Inspections Summit: **Presented by FDAnews** Oct. 23-25, 2019 – Bethesda, MD http://www.fdanews.com/fdainspectionssummit

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Announcing the 14th Annual FDA Inspections Summit, far and away the number one event for quality, compliance and regulatory professionals.

Over the course of two-and-a-half days, attendees will learn vital information from current and former FDA officials and industry experts aiming at inspectional readiness.

Attendees will choose from three different tracks: Drugs & Biologics, Medical Devices and Clinical Trials to guarantee they are inspection-ready and are comfortable with the tools and tactics applied on the job.

The pre-conference workshop options on Oct. 23 are:

• Flawless FDA Inspection Handling and Response (Drugs & Biologics Track)
• How to Pass an FDA QSR Inspection (Medical Devices Track)
• ICH E6(R2): How to Be Inspection Ready with Your Sponsor Risk Management Program (Clinical Trials Track)

The first day will cover how to create a world-class quality culture, attend a panel discussion on the 10 best and 10 worst things to do when FDA staff are on site and gain focus through a mock inspection interactive exercise. During the day's three breakout tracks, attendees can choose:

• Drugs & Biologics Track
• Concept of Operations: How Integration of the FDA Facility Evaluation and Inspection Program Impacts Your Organizations
• Today's Track & Trace: What Merck and the FDA Have Learned
• Panel Discussion: The US/EU Mutual Recognition Agreement (MRA) for Drug GMP Inspections
• Medical Devices Track
• FDA's Shift from QSR to ISO 13485:2016: A Significant Change for Inspections
• Preparing for a MDSAP Audit: A Case Study from the Manufacturer's Perspective
• Panel Discussion: EU-MDR: Final Push for Compliance by the May 26, 2020 Deadline
• Clinical Trials Track
• Meeting CRO-Vendor Oversight Requirements
• Validating Your Systems and Equipment for Compliance
• Quality by Design — Build Quality into Clinical Trials to Proactively Identify and Mitigate Risks

Day two gets attendees inspection-ready through covering:

• The latest patterns in FDA's 483s and warning letters, so you can pass your next inspections easily
• Good techniques for data organization and how to create effective new SOPs for electronic document management
• New developments in FDA's field operations reorganization and program alignment; how this will impact your inspections?

The summit's agenda, presentations and panel discussions are simply unmatched. Ensure successful inspections each time with this best-in-class summit.

Who Will Benefit:

• Drugmakers
• Devicemakers
• Biologics firms
• Clinical trials
• Clinical research organizations
• Diagnostics firms
• Executive suite
• Manufacturing/GMP
• QA/QC
• Regulatory affairs
• Strategic planners
• Legal counsel
• Consultants

Conference Details 14h Annual FDA Inspections Summit: **Presented by FDAnews** Oct. 23-25, 2019 – Bethesda, MD http://www.fdanews.com/fdainspectionssummit Tuition: Early Bird Registration (until Sept. 20, 2019): Complete Summit $1,797 Regular Registration (Sept. 21, 2019 on): Complete Summit $1,997 Additional pricing and livestreaming options are available online.

Easy Ways to Register: Online:     http://www.fdanews.com/fdainspectionssummit 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.

 

SOURCE FDAnews