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WCG FDAnews Announces the 17th Annual FDA Inspections Summit, Nov. 16-18, 2022, Washington, DC

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FALLS CHURCH, Va. (PRWEB)

17th Annual FDA Inspections Summit

**Presented by WCG FDAnews**

Nov. 16-18, 2022 • Washington, DC

https://wcg.swoogo.com/fda-inspections-summit-2022

The 17th Annual FDA Inspections Summit has exactly what drug and device manufacturers, and clinical trial professionals need to successfully navigate inspections into 2023 and beyond.

Attendees can save up to $200 by registering by the early bird deadline of Oct. 21.

This year’s summit features industry experts, including past and present FDA officials, will present and lead the hands-on sessions needed for inspection success.

The plenary sessions and breakout tracks for Drugs & Biologics, Medical Devices and Clinical Trials are packed with timely topics that will provide a wealth of insight, including:


  •     The FDA Perspective on Inspections: What’s Happening Now and What to Expect in 2023


The FDA’s latest plans and initiatives straight from the FDA. Elizabeth Miller, Pharm.D., assistant commissioner for medical products and tobacco operations in the Office of Regulatory Affairs delivers the keynote address, sharing what to expect from the agency.

  • Mock Inspection: Practice Makes Perfect


An interactive inspection so attendees are ready for anything the next time the FDA shows up. With Thomas Berry, senior vice president, regulatory compliance at Greenleaf Health, Inc. and former director of compliance, Office of Pharmaceutical Quality Operations (OPQ); Simone Pitts, FDA national expert, pharmaceutical; and Kalah Auchincloss, executive vice president, regulatory compliance and deputy general counsel of Greenleaf Health, Inc. and former deputy chief of staff, FDA

  • Communicating with the FDA: How to Facilitate an Inspection Post-COVID


How to communicate with the FDA regarding when a site might expect an inspection and how to make that inspection happen sooner. With Mark Schwartz, director at Hyman, Phelps & McNamara and the former deputy director of the FDA’s Office of Compliance and Biologics Quality (OCBQ); Grace McNally, senior vice president, regulatory compliance at Greenleaf Health, Inc. and 33-year FDA veteran; and Kalah Auchincloss.

  • Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections


How to create effective new SOPs for electronic document management or improve existing ones so your next inspection day doesn’t become scavenger hunt day. With David L. Chesney, principal and general manager, DL Chesney Consulting LLC and 23-year FDA veteran, including serving as district director in San Francisco.

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


The best and worst of the industry’s performance as an informative lesson. With John Taylor, president and principal, compliance and regulatory affairs at Greenleaf Health LLC, and 20-year FDA veteran; Cathy Burgess, partner at Alston & Bird, leading the firm’s FDA compliance and enforcement team; Sarah Tanksley, president & CEO of Tanksely Consulting Group and former FDA consumer safety officer; and Kalah Auchincloss.

Attend in person or live-stream the summit. The entire conference, including pre-conference workshops, is available in real time via livestreaming. Register by Oct. 21 to take advantage of the early bird registration discounts.

Conference Details

17th Annual FDA Inspections Summit

**Presented by WCG FDAnews**

Nov. 16-18, 2022 • Washington, DC

https://wcg.swoogo.com/fda-inspections-summit-2022

Tuition:

Early Bird Registration (until Oct. 21, 2022): Complete Summit $1,797

Regular Registration (Oct. 22, 2022 on): Complete Summit $1,997

Additional pricing and livestreaming options are available online.

Easy Ways to Register:

Online: https://wcg.swoogo.com/fda-inspections-summit-2022

By phone: 888-838-5578 or 703-538-7600

About WCG FDAnews:

WCG 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 WCG FDAnews’ newsletters, books, databases, webinars and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations. Learn more at fdanews.com.

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