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Will Your Next Regulatory Audit Be On-Site, Virtual or Hybrid? Management Report

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WCG FDAnews

WCG FDAnews


FALLS CHURCH, Va. (PRWEB)

New Inspection Models:

Will Your Next Regulatory Audit Be On-Site, Virtual or Hybrid?

https://www.fdanews.com/products/61892

Are good manufacturing process inspections forever changed or will on-site inspections come back? The lessons regulators are learning now will inform inspection models going forward — prepare now or risk Form 483s or warning letters.

Whether virtual, hybrid or on-site, New Inspection Models: Will Your Next Regulatory Audit Be On-Site, Virtual or Hybrid? will ensure future inspections — in all forms — go well.

This management report prepares one for whatever the future brings. It explains what regulators expect to see and do in a remote audit (documents, records, staff interviews, virtual tours), how to prepare for new technical requirements and how communication differs. Readers will also gain insight into on-site inspections.

New Inspection Models will explain how to handle all kinds of inspections with ease, sharing:


  • How regulators will choose which manufacturers to inspect

  • How often you can expect to be inspected in the post-pandemic era and whether there will be extra steps (reviews, meetings) between inspections

  • Guidance from the FDA and the EMA on dealing with remote inspections

  • Different types of audits and how to prepare for them

  • Effective document and data integrity control

  • How to view a virtual inspection from both the regulator’s and the manufacturer’s perspectives

In the pandemic, the FDA and other agencies are making the rules for good manufacturing process inspections as they go. New Inspection Models: Will Your Next Regulatory Audit Be On-Site, Virtual or Hybrid? provides everything one needs to stay steps ahead.

Management Report Details:

New Inspection Models:

Will Your Next Regulatory Audit Be On-Site, Virtual or Hybrid?

https://www.fdanews.com/products/61892

Price:

$397

Easy Ways to Order:

Online: https://www.fdanews.com/products/61892

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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