They’re Back — But When, Where and How Webinar August 12, 2021


WCG FDAnews

WCG FDAnews

On-Site Inspections:

They’re Back — But When, Where and How

An FDAnews Webinar

Thursday, Aug. 12, 2021, 1:30 p.m. – 3:00 p.m. EDT

https://wcg.swoogo.com/on-site-inspections

The development and distribution of COVID-19 vaccines have helped the global health crisis take a positive turn in some parts of the world. This change has many manufacturers pushing to shift some practices back to pre-pandemic norms — including a return to on-site inspections and audits.

How can drug and devicemakers effectively merge the best practices for conducting on-site and virtual inspections?

During the pandemic, regulatory agencies developed guidance on conducting virtual audits and there have long been guidelines around on-site audits. This webinar will bring those two sets of expectations together to consider how post-pandemic audits may look. Regulatory compliance experts Sue Schniepp, Seyed Khorashahi and Steve Lynn will share insights on the likely structure of blended on-site and virtual inspections and audits — and explore ways to merge these best practices and develop an efficient, effective model.

During this webinar, they’ll cover:

● Virtual Audit Practices

         a. Best practices for conducting virtual audits

● On-site Audit Practices

         a. Best practices for conducting on-site audits

● Models for Post-Pandemic Audits

         a. Frameworks for combining virtual audits and on-site audits

         b. Improving effectiveness and efficiency

         c. Maintaining oversight of suppliers, contract manufacturers and test

             laboratories

         d. Understanding the operational changes needed to keep facilities safe

             during on-site inspections

The journey to pre-pandemic practices has already begun and on-site audits and inspections are on their way back. Prepare for these changes and get the insights needed to merge virtual practices with on-site interactions during this webinar.

Interested in registering multiple sites?

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally

to learn about our special multisite discount.

Webinar Details:

On-Site Inspections:

They’re Back — But When, Where and How

An FDAnews Webinar

Thursday, Aug. 12, 2021, 1:30 p.m. – 3:00 p.m. EDT

https://wcg.swoogo.com/on-site-inspections

Tuition:

$297 per site

Easy Ways to Register:

Online: https://wcg.swoogo.com/on-site-inspections

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

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