4-hr Virtual Seminar: Using the USP Effectively

Why Should You Attend:

This course is designed to provide participants with an understanding of the USP, including both the organization and the published standards, and strategies for assuring conformance to USP standards.  The course will cover the major USP publications, the type of content in each and regulatory expectations regarding their use.

In addition, the course will cover when deviations from the published standards are acceptable, and the mechanisms for being aware of pending changes to the USP, and how to influence the changes.

The speaker will actively solicit questions from the participants and address them by the end of the webinar.

Duration:

4 hours of instruction, and breaks as appropriate.

Learning Objectives:

Upon completion of this course the learner should be able to:

• Understand the USP, including the organization and information it provides, and the relationship to FDA.
• Be familiar with the sections of the USP/NF, including General Notices, General Chapters and Monographs.
• Use USP procedures and reference standards as provided, and be aware of alternative options.
• Understand that the PF is the primary communication tool used by USP to inform the public of changes, and that it is now readily available for free.
• Know how to influence the USP and be aware of current Hot Topics

Agenda: (All time in EDT)

Part 1:  Understanding How Sections are Inter-related, and Options for Implementation

• 11:00 – 11:20  Organization of USP
• 11:20 – 11:50  USP/NF
• 11:50 – 12:20  Discussion on Monographs
• 12:20 – 12:30  Reference Standards
• 12:30 – 1:00  Conformance to USP
• 1:00 – 1:15  Break

Part 2:  Managing and Influencing Change

• 1:15 – 1:30  PF
• 1:30 – 2:10  How to influence USP
• 2:10 – 2:55  Current Hot Topics
• 2:55 – 3:15  Attendee Questions and Answers

Course Syllabus:

Who will benefit:

Manufacturers of drug substances, drug products or excipients and dietary supplements will benefit from this training.

• Chemists
• Regulatory Affairs
• Laboratory managers and staff
• Analysts
• QA/QC managers and personnel
• All personnel involved in developing or using pharmaceutical analytical standards

Instructor Profile:

Gregory Martin , is the founder and President of Complectors Consulting LLC, which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Greg is Vice Chair of the USP General Chapters Expert Committee, and has over 29 years experience in the pharmaceutical industry, including ten years as Director of Pharmaceutical Analytical Chemistry in Merck Research Laboratories. Greg's interests include impurities and residual solvents, dissolution, analytical instrument qualification and other topics related to laboratory GMP compliance.

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