Regulatory Inspections and Quality Audits


Instructor: Martin Lessem
Product ID: 706345

  • Duration: 90 Min
This course will focus on Regulatory Inspections and Quality Audits. It will cover Health Authority inspections as well as internal Quality Audits and also managing corrective action plans that can result from audits.
Last Recorded Date: Mar-2020


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Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
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Read Frequently Asked Questions

Why Should You Attend:

Regulatory Inspections and Quality Audits are something every Pharmaceutical and Biotech company should be familiar with. These can be inspections conducted by Health Authorities, such as the US Food and Drug Administration, or they can be audits the company does internally to either prepare for a Health Authority inspection, or just to ensure proper operations at their manufacturing sites. This course will cover the basics for both of these types of inspections and audits, including giving companies basics to be prepared for both the inspection/audit and the outcomes.

  • Gain a better understanding of Inspections by Health Authorities
  • Better understand reasons for conducting internal voluntary audits
  • Understand the importance of Health Authority Communications with regard to Inspections
  • Understand the roles of Regulatory, Quality Assurance, CMC and Manufacturing play in Inspections and Audits
  • Better understand the outcomes of Inspections and Audits and what companies next steps should be in dealing with them

Areas Covered in the Webinar:

  • FDA Audits/Inspections
  • Other Health Authority Audits
  • Pre-Inspection/Audit Preparation
  • Internal Roles during an Inspection/Audit
  • Dealing with the aftermath of Health Authority Inspections
  • The 483 Form
  • Internal Audit results and how to handle them
  • Reporting requirements for internal audits

Who Will Benefit:

  • Regulatory Affairs, Quality Assurance, CMC, Manufacturing


  • Pharmaceutical Industry

Frequently Asked Questions:

  • Our company have routine audits since the product is registered with FDA and data integrity is very important now. As we perform our departmental internal audits, what should we be looking for during our audits to help identify issues.

Free Materials:

  • Rule documents or guidance
  • Slide Show
  • Checklist
Instructor Profile:
Martin Lessem

Martin Lessem
Principal Consultant, Lessem Regulatory Consulting LLC

Martin A. Lessem, J.D. is a professional with 17 years of experience in Pharmaceuticals. In the past 12 years he has been heavily involved with Regulatory Risk Management and worked on many of the larger industry programs. He has worked at large companies, small companies, innovator companies, and generic companies and has worked in risk management in all those settings. Currently, he is a consultant to Pharmaceutical companies on Regulatory Strategy and Risk Management.

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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