Manufacturing Quality: Using Audit Observations to Predict Problems – Webinar Recording/Transcript
Supplier audits, self-audits, regulatory audits and client audits are all part of any company’s audit program.
Not only can they point to problems that need to be corrected, audits can also show trends that predict future issues, allowing you to get ahead of the problem and avoid manufacturing delays or, worst case, drug shortages.
Whether your product is on the market or in development, auditing can help ensure efficiency and regulatory compliance. This presentation explores how to use all the information from the various audits as a predictive tool that is part of a comprehensive quality risk management program.
After attending this presentation, you will know:
- How to use a risk-based approach to audits
- The importance of quality culture and regulatory requirements identifying quality culture
- Steps to take when a quality issue is identified through the audit process
- The best practices for documenting and tracking resolutions to identified issues
- How to effectively implement quality risk management concepts based on audit observations
- How audit data can be used proactively to drive continuous process improvement
- How audits generate valuable information regarding the overall efficiency of operations
- How to respond within the required 15 business days to FDA inspection observations
- How you can refocus your internal audit programs to predict problems that might arise in the future
- How you can link audit observations from different sources to create a complete picture of operations and determine where resources may be needed
Meet Your Moderator
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates (RCA), is the knowledge leader responsible for training and advising RCA staff and clients on current trends and issues facing the pharmaceutical, biotechnology and medical device industries. Her background includes audit readiness, change control, investigations, supplier quality and batch record reviews. Ms. Schniepp has more than 40 years’ experience in quality assurance, serving in leadership roles at Allergy Laboratories, OsoBioPharmaceuticals, Searle, Abbott and Hospira. In addition, she served on the Parenteral Drug Association Board of Directors from 2011-2013 and 2016-2019 and currently serves as the Chair-Elect.
Meet Your Panelists
Steven Lynn, executive vice president of pharmaceuticals for Regulatory Compliance Associates, has more than 20 years of quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma and tissue industries. Prior to joining RCA, he served in executive leadership roles with global accountability in the private sector as well as at the FDA. While at the agency, he was the director of the Office of Manufacturing and Product Quality in the Center for Drug Evaluation and Research. In this role, he was responsible for the global oversight of all drugs manufactured and/or imported into the U.S. In addition, in his last year at the FDA, he also served as the operations transition lead for CDER’s new Office of Pharmaceutical Quality.
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 and he has an extensive background in medical device product development, quality systems, regulatory affairs, mergers and acquisitions, engineering and business strategy.
Michael de la Torre is the founder and CEO of Redica Systems, a data and analytics platform that helps life sciences companies stay compliant with changing regulations and enforcement. He previously served as the chief research officer for LeisureLink, a VP/GM at Sungard Availability Services and started his career at McKinsey.
Who Will Benefit
- Quality assurance Personnel (all levels)
- Operations Personnel (all levels)
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Jan. 19, 2023