FDAnews Announces 15th Annual FDA Inspections Virtual Summit Nov. 17-18, 2020

Share Article

Remain inspection-ready with this practical, information-packed vSummit featuring current/former FDA insiders and industry experts.



15th Annual FDA Inspections vSummit:
An FDAnews Virtual Summit
Tuesday, Nov. 17-Wednesday, Nov. 18, 2020

Inspections are different this year, but is this the new normal or just a temporary adjustment? In either scenario, preparing for virtual inspections due to COVID-19 precautions is critical to moving through the process successfully. Are you ready?

At the 15th Annual FDA Inspections vSummit, attendees will gain insights and tips to help plan for upcoming inspections. With the expertise of seasoned professionals, this virtual summit will tackle complex inspection issues head-on — providing details that will ease the stress of determining any next steps.

The summit will cover everything a team needs to know to move through an inspection. FDA officials and industry experts will share the best tools for participating in virtual interactions, how to prepare for a regulatory meeting, ways COVID-19 has impacted the inspection process and much more.

On both days, attendees will dig into the track that best matches one’s needs, taking these exclusive industry insights and applying them to the company’s business processes and goals.

  • Drugs and biologics track

     - Day 1 — Nov. 17
             - What one should expect from FDA drug GMP facility evaluations and
                 inspections during the pandemic
             - How to ensure drug GMP inspection readiness
     - Day 2 — Nov. 18
             - Managing risks and ensuring quality in a global supply chain
             - Inspection compliance in 2020 and expectations for 2021

  • Medical devices track

     - Day 1 — Nov. 17
             - CDRH Quality Pilot: Implementing a capability maturity model
             - Cybersecurity developments
     - Day 2 — Nov. 18
             - Managing virtual MDSAP inspections
             - Managing medical device recalls

  • Clinical trials track

     - Day 1 — Nov. 17
             - Deploying the right tools from the virtual clinical trials toolbox
             - Quality by Design: Building quality into clinical trials to proactively
                identify and mitigate risks
     - Day 2 — Nov. 18
             - Strategies for managing mobile remote audits and inspections
             - Obtaining and documenting informed consent when a patient is not
             physically present

There’s no other summit where one will leave as well prepared for the complicated task of preparing for an inspection. Mark the calendar now. Don’t miss out on this chance to learn from seasoned inspections experts and prepare the team for compliance and success.

Early Bird $100 discount!
Sign up through Oct. 16 and get $100 off the regular price.

Multi-attendee discounts available!
Significant tuition discounts are available for teams of two or more from the same company.

Virtual Conference Details:
15th Annual FDA Inspections vSummit:
An FDAnews Virtual Summit
Tuesday, Nov. 17-Wednesday, Nov. 18, 2020

Early Bird Pricing (before Oct. 16): $597
Regular Pricing: $697

Easy Ways to Register:
Online: https://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.

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Michelle Butler
Email >
Visit website