Understanding the USP and FDA Functions in the Pharmaceutical Industry

Duration: 60 Minutes
Attending this webinar will help the attendees recognize the corporate risks of sole reliance on existing USP methods and the importance of assigning resources to increase business efficiencies and reduce corporate liability by systematically applying the improvements supported by CGMP regulations.
USP and FDA Functions
Instructor: Richard Youngstrom
Product ID: 501700
Objectives of the Presentation
  • Functions of pharmacopeias and the USP
  • Misperceptions of importance of USP methods and regulatory status of the USP
  • Conflicts in the charters of the USP and the FDA
  • Conflicts in the USP consensus process and the FDA goal of continual implementation of current technology in the pharmaceutical industry
  • Illustrate business inefficiencies in USP monographs and the liabilities inherent in reliance on USP methods
  • Illustrate the simplicity of obtaining increased business efficiencies and reduced corporate risk by developing improved analytical and manufacturing processes
  • Illustrate the FDA emphasis on integrating new technology into pharmaceutical operations to improve safety and quality
  • Recognize the business and compliance advantages of using the USP as a resource reference, while developing and implementing current technology
Why Should you Attend
This webinar provides the participant with an understanding of the history of 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 to work together, without recognizing the conflicts in the approaches and goals. The presentation discusses the inefficiencies inherent in USP monographs and the liabilities the user accepts with full reliance on USP methods without recognizing and accommodating the intent of CGMP in their quality systems. The presentation provides examples of business inefficiencies inherent in the use of USP monographs, as well as critical liabilities associated with the design of USP monographs. The presentation 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
  • Function of the USP to share established methodology to support the growth of the generic pharmaceutical industry
  • Absence of enforcement power for use of USP methods and regulatory status of the USP as a communication tool
  • Conflicts in the charters of the USP and the FDA
  • Inherent inefficiencies in the USP monograph creation process and associated liabilities created by a retrospective perspective design
  • Illustrate the FDA emphasis on integrating new technology into pharmaceutical operations to improve safety and quality
Who will Benefit
  • All generic pharmaceutical company QC Directors, QC Managers, QC Chemists, ARD Directors, ARD Managers, ARD Chemists
  • This presentation is directed toward all users in the generic pharmaceutical industry, including contract laboratories, API manufacturers, and pharmaceutical manufacturers, with additional benefit to any users currently relying on the use of USP monographs without modification.
$375
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Richard Youngstrom is a Senior Compliance Consultant in the Pharmaceutical industry with extensive experience (30+ years) in GMP LaboratoryCompliance and Quality System improvements. In 2013, Richard retired from his position as Director of Quality Control at Braintree Laboratories and transitioned into Pharmaceutical consulting 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.

Mr. Youngstrom started his career with Schering Corporation in early drug discovery, and advanced through several positions to Senior Group Leader in Radiochemistry. Richard's product line experience includes radiopharmaceuticals, APIs, solid and semi-solid dose formulations, liquids, transdermal products and OTC drugs.

He is also a certified technical trainer and has conducted FDA Analyst Certification programs for a number of companies. Utilizing his ASQ CQA and CPGP certifications, he has conducted a full range of audits including clinical audits, supplier qualification, general compliance audits, and for-cause corrective action audits, within the United States and internationally.


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