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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.
Learn about Virtual Audits Best Practices →
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.
- 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- FDA Data Integrity and Compliance with CGMP Guidance for Industry Draft Guidance (April 2016)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.
Check out some of our Pre-Webinar Reading Material.