On-Site Inspections: They’re Back — But When, Where and How – Webinar Recording/Transcript
With the development and distribution of COVID-19 vaccines, the global health crisis is beginning to take a turn in some parts of the world. These changes have brought a strong desire to shift certain practices back to pre-pandemic norms — including a return to on-site inspections and audits.
Now drug and devicemakers are faced with the question of how to most effectively merge the best practices for conducting inspections before and during the COVID-19 crisis. It’s a task without a playbook but there are avenues to create one.
Regulatory agencies have 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. They will explore how these merged best practices will likely move forward and tips for developing an efficient, effective model.
- Virtual Audit Practices
- Best practices for conducting virtual audits
- On-site Audit Practices
- Best practices for conducting on-site audits
- Models for Post-Pandemic Audits
- Frameworks for combining virtual audits and on-site audits
- Improving effectiveness and efficiency
- Maintaining oversight of suppliers, contract manufacturers and test laboratories
- Understanding the operational changes needed to keep facilities safe during on-site inspections
The world will soon be returning to many pre-pandemic practices, including on-site audits and inspections. Get prepared for these changes and find the insights you need to merge your virtual practices with on-site interactions during this presentation.
Meet Your Presenters
Sue Schniepp is a distinguished fellow at Regulatory Compliance Associates and a data integrity expert. She has served on the board of directors of the Parenteral Drug Association as the PDA/FDA Joint Regulatory Affairs conference chair and as chair of the PDA’s Regulatory Affairs/Quality Advisory Board. She has been a PDA conference presenter and was awarded PDA’s Distinguished Service Award.
Seyed Khorashahi has more than 25 years of experience leading research and development teams in all aspects of creating safety-critical medical devices. He has held leadership positions at Covidien (Medtronic), Baxter and Beckman Coulter, Inc. and he has an extensive background in medical device product development, quality systems, regulatory affairs, mergers and acquisitions, engineering and business strategy. He returned to Regulatory Compliance Associates Inc. (RCA) in 2015 as COO and now works in conjunction with the CEO and Board of Directors to define operational and technical strategy, as well as plan and develop the primary processes to support client service delivery.
Steve Lynn has more than 20 years of experience in quality and regulatory compliance concerning pharmaceutical, biopharmaceutical, medical device, blood, plasma and tissue industries. He served in executive leadership roles with global accountability in both the private sector and the FDA. Lynn is an expert in matters related to cGMP compliance and has significant experience with other GxP quality compliance and regulatory issues. He is currently the principal consultant and owner of Lynn Consulting, LLC, which provides expert GxP consulting services to the life sciences industry.
Who Will Benefit
- Pharmaceutical, biological and medical device companies
- Supplier and contract manufacturing companies
- Contract testing laboratories
- Audit managers
- Quality assurance and quality control leaders
- Operations directors
- Operations personnel
- Regulatory affairs leadership
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Aug. 12, 2021