How to Master Remote GMP Audits and When to Avoid Them
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The Covid-19 pandemic has almost eliminated onsite regulatory and supplier audits. It brought compliance uncertainty upon both regulators and manufacturers.
A new type of audit has emerged through evolution- The Remote Inspection.
Now that we are (hopefully!) nearing the end of the pandemic, one question remains- will the Remote Inspections stay with us or disappear?
Most likely, it will stay with us to some degree, as it has some benefits. Furthermore, the industry will most certainly adopt a mixed approach.
However, it means confusion and chaos for inexperienced auditors and auditee’s.
Virtual audits present new challenges and dilemmas, such as:
- What types of audits are ideal for remote inspection, and which should you do only onsite?
- How to deal with and manage document review effectively?
- How to overcome technical issues, and what backup plans should you have?
- What to do when the auditee doesn’t want to cooperate?
In this webinar, you will learn to answer the questions above and more. You will get practical advice and recommendations for preparedness and how to conduct virtual inspections effectively.
The speaker for this webinar, Fenton Fong, is a seasoned GMP manufacturing/compliance consultant expert. He has conducted a wide variety of compliance audits throughout his career and transitioned to having conducted over 20 remote inspections since 2020.
He will provide practical advice and lessons from the pandemic and the near return to onsite auditing.
After attending the webinar, you will have more confidence in the upcoming remote audits’ preparations and execution. Additionally, you will know how to mix it up better with remote and onsite audits.
Who Should Attend:
Quality professionals, quality compliance groups, and fellow GMP inspectors.
- Skill Level: Intermediate , Expert
- Types of audits that are ideal for remote audit format
- Risk assessment
- Criticality of the audit subject
- Auditee standards/policies/procedures
- Preparation for and managing document reviews
- Hard copy vs. electronic
- Active vs. passive scrolling access
- Screen space
- Video interfacing, live virtual tours, and backup plans
- Site tours and floorplan drawings
- To turn the camera on or off, that is the question!
- Reading the lay of the land
- Return to onsite auditing
- Daily testing with rapid test kits
- Onsite positive test results
- Will we return to complete onsite inspections?
Fenton Fong is a Biotech/pharma industry professional with 30 years of corporate and consulting experience in CMC/manufacturing and Quality/Compliance. Fenton is a Founder and Principal at xCellarate, an industry consulting firm based in Canada, and provides value-added solutions to Biotech/Pharma, Medical Devices clients in Canada/USA, Asia.
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