This webinar provides the participant with an understanding of the history of US pharmacopeias as reference guides for the preparation of standard medicines, which existed centuries before the US government saw the need to establish the FDA.
When Congress created the USP, it empowered the FDA and USP convention to work together, without recognizing the conflicts in the approaches and goals.
The webinar discusses the liabilities the user accepts with full reliance on USP methods without investigating allowable adjustments in regulatory compliance and the intent of CGMP regulations in their quality systems.
Why Should You Attend:
The webinar suggests that the approach to improved cost-efficiency and compliance is through investment in additional analytical development to ensure that the user has maximized laboratory efficiency and minimized regulatory risks.
Areas Covered in this Webinar:
• Functions of pharmacopeias
• Function of the USP
• Clarify misperceptions of regulatory status of the USP
• Conflicts in the charters of the USP and the FDA
• Support understanding of the business costs and corporate liability risks of reliance on USP methodology
• Documenting the FDA support for implementation of improved methodology
Who Will Benefit:
• Pharmaceutical Company QC Directors
• QC Managers
• QC Chemists
• ARD Directors
• ARD Managers
• ARD Chemists
Richard Youngstrom is a Senior Compliance Consultant in the Pharmaceutical industry with extensive experience (30+ years) in GMP Laboratory Compliance and Quality System improvements.
In 2013, Richard retired from his position as Director of Quality Control at Braintree Laboratories and transitioned into Pharmaceutical consulting and training to help pharma clients meet current regulatory guidelines and improve laboratory compliance and efficiencies; i.e. leveraging his expertise in auditing, OOS laboratory & manufacturing investigations, training, and test method optimization to gain quality efficiencies.
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