FDAnews Announces -- The 16th Annual FDA Inspections vSummit Nov. 16-17, 2021
Get inspection-ready with this practical, information-packed vSummit featuring current/former FDA insiders and industry experts.
FALLS CHURCH, Va., Sept. 27, 2021 /PRNewswire-PRWeb/ -- 16th Annual FDA Inspections vSummit
An FDAnews Virtual Summit
Tuesday-Wednesday, Nov. 16-17, 2021
https://wcg.swoogo.com/fda-inspections-summit?
There's little doubt that the FDA's inspections schedule has been dramatically affected by the surge in Delta variant COVID-19 cases. But the FDA is on track to resume onsite inspections and continue alternative inspection methods when and where possible.
In May, the FDA released what it called a "resiliency roadmap" for a more normal schedule of inspections based on three pandemic scenarios — best-case immediate, best-case gradual and a worst-case.
In the best-case immediate scenario, the FDA projected that it would conduct half — 1,613 — of the remaining 3,229 planned domestic drug inspections for the fiscal year ending on Sept. 30. With a best-case gradual transition to normal operations, the FDA predicted it could conduct slightly more than a quarter — 851 — of the remaining planned domestic drug inspections for the fiscal year. The agency didn't make projections for the worst-case scenario in which it assumed a COVID-19 surge — which has come to pass with the Delta variant, resulting in only 295 domestic and 44 foreign pharmaceutical inspections completed through Sept. 14.
Are good manufacturing process inspections forever altered by the global pandemic? Are virtual inspections here to stay? Will they return to in-person or become a combination of virtual and in-person? The challenges regulators are confronting now will inform inspection models and schedules going forward — prepare now or risk Form 483s or warning letters.
At the 16th Annual FDA Inspections vSummit, attendees will gain insights and tips to help plan for inspections now and into 2022. 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 your next steps.
The summit will cover everything one needs to know to move through an inspection. FDA officials and industry experts will share the best tools for participating in virtual or in-person inspections, discuss assessing when recall situations arise and detail the benefits of artificial intelligence and much more.
On the first day keynote speaker, Elizabeth Miller, Pharm.D. — Assistant Commissioner Medical Products & Tobacco Operation Office of Regulatory Affairs, FDA — will discuss the FDA's perspectives on inspections and what one can expect now and in 2022.
Both days, attendees will dig into the track that best matches your needs, taking these exclusive industry insights and applying them to your company's business processes and goals.
•Drugs and biologics track
o Day 1 — Nov. 16
- How the FDA is using remote tools in addition to or in lieu of traditional inspections
- Ensure drug GMP readiness for remote or in-person inspections
o Day 2 — Nov. 17
- Expedite an inspection and escape the schedule queue
- Inspection compliance in 2021 and expectations for 2022
•Medical devices track
o Day 1 — Nov. 16
- Harmonizing Quality Systems Regulation — will inspections adjustments be made?
- What to expect from the FDA's new Inspection Affairs Council
o Day 2 — Nov. 17
- Long-term impact of remote regulatory assessments
- Responding to FDA enforcement actions
•vClinical trials track
o Day 1 — Nov. 16
- How COVID-19 has taught us to streamline and simplify the clinical trial process
- FDA expectations for remote informed consent
o Day 2 — Nov. 17
- What to expect from clinical studies post-COVID
- Meeting CRO vendor oversight requirements
There's no other summit where one will leave as well-prepared for the complicated task of preparing for an inspection. 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. 19 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 Workshop Details:
16th Annual FDA Inspections vSummit
An FDAnews Virtual Summit
Tuesday-Wednesday, Nov. 16-17, 2021
https://wcg.swoogo.com/fda-inspections-summit
Tuition:
Single Attendee - $597.00
Group of 2-4 Attendees (Save 10%) - $527.00
Group of 5-6 Attendees (Save 15%) - $492.00
Group of 7-9 Attendees (Save 20%) - $458.00
Group of 10+ Attendees (Save 25%) - $423.00
Easy Ways to Register:
Online: https://wcg.swoogo.com/fda-inspections-summit
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
Media Contact
Michelle Butler, FDAnews, 703.538.7600, [email protected]
SOURCE FDAnews
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