Product Details
Regulators are focused on manufacturers’ quality issues. You only need to look into the issuance of global guidance documents over the past few years: they consistently link data integrity and quality issues/quality culture.
Are you conducting effective audits? Whether your product is on the market or in development, your processes and your business must run smoothly. You can also ensure compliance when you are able to identify and correct these issues before they impact your operations.
Gain confidence that your product meets the necessary quality standards and ensure compliance. Susan Schniepp has 40 years of high-level quality assurance experience in the pharmaceutical industry. Susan will lead a 90-minute panel discussion with Seyed Khorashahi and Steve Lynn from Regulatory Compliance Associates® Inc. The panel will help you prepare, organize and streamline your audit approach so you can identify quality issues or work with your client on solutions to establish a more robust operation that stands up to regulatory scrutiny.
Presentation Takeaways:
- How to use a risk-based approach to audits
- Understand the importance of quality culture and regulatory requirements identifying quality culture
- Steps to take with the manufacturer when a quality issue is identified
- What are the best practices for documenting and tracking resolutions to identified issues
- How to work effectively with the manufacturer to implement quality risk management concepts
- What you must know about key regulations
- ICH Q9 Quality Risk Management
- MHRA GMP Data Integrity Definitions and Guidance for Industry (March 2015)
- MHRA: A GxP Data Integrity Definitions and Guidance for Industry Draft version for consultation (July 2016)
- FDA Data Integrity and Compliance with CGMP Guidance for Industry Draft Guidance (April 2016)
- WHO: Annex 5, Guidance on good data and record management practices (June 2016)
- Draft PIC/S Guidance: Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (August 2016)
Use risk-based approaches to manufacturing audits and you’ll identify and mitigate quality issues before they impact business operations.
Meet Your Presenter
Susan Schniepp
Distinguished Fellow, Regulatory Compliance Associates® Inc.
Susan Schniepp has 40 years of quality assurance experience in the pharmaceutical industry. She served in leadership roles at Allergy Laboratories, Inc.; OsoBio Pharmaceuticals, LLC; Searle; Abbott and Hospira. She has earned several awards from the Parenteral Drug Association (PDA), including its Distinguished Author Award, Distinguished Service Award and Gordon Personeus Award. Her publications include the book Understanding the United States Pharmacopeia and the National Formulary: Demystifying the Standards-Setting Process for which she was awarded the 2007 PDA Distinguished Author Award. She co-edited and contributed to the books Pharmaceutical Outsourcing: Quality Management and Project Delivery and SOPs Clear and Simple for Healthcare Manufacturers. She has served as a member of the PDA Board of Directors from 2011 to 2013 and from 2016 to 2019 and is the chair-elect starting in January 2020. Ms. Schniepp has served on numerous planning committees for PDA including the PDA/FDA Joint Regulatory Conference Planning Committee since 2002. She is currently working with other PDA members on a technical report relating to manufacturing data integrity issues as well as participating in PDA’s standard-setting activity regarding purchasing controls. In addition to her PDA activities, Ms. Schniepp is an editorial advisory board member and columnist for Pharmaceutical Technology (since 2007) and BioPharm International magazines.
Seyed Khorashahi
Executive VP of Medical Device and CTO, Regulatory Compliance Associates® Inc.
Seyed Khorashahi has more than 25 years’ experience leading R&D teams in all aspects of developing safety critical medical devices. He has held leadership positions at Covidien (Medtronic), Baxter, and Beckman Coulter, Inc., and has an extensive background in medical device product development, quality systems, regulatory affairs, and mergers and acquisitions. Other core competencies include engineering and business strategy.
Steven J. Lynn, MS
Executive VP, Pharmaceuticals - Regulatory Compliance Associates® Inc.
Steve Lynn has over 20 years of quality and regulatory compliance related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma, and tissue industries. He is an expert in Current Good Manufacturing Practices (CGMP) compliance-related matters and has significant experience with other GxP quality compliance and regulatory issues. Prior to joining RCA, Steve served in executive leadership roles with global accountability in both the private sector, as well as at the US FDA.
Who Will Benefit
- Assurance Personnel (all levels)
- Operations Personnel (all levels)
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Webinar date:
Feb. 17, 2021