ComplianceOnline

4-hr Virtual Seminar: Using the USP Effectively

Instructor: Gregory Martin
Product ID: 702019
  • Duration: 4 hrs

Training CD

$999.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This 4 hour virtual seminar will provide a solid understanding of the USP, its sections and how they are inter-related. Attendees will also learn how to be aware of changes to the USP, and how to influence them.

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:

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

  • Organization of USP (20 min)
    • Mission
      • Relationship to FDA
    • People
      • Professional Staff
      • Volunteers
    • Programs and Services
      • USP/NF
      • PF
      • Other
  • USP/NF (30 min)
    • USP vs. NF content
    • General Notices
    • General Chapters
      • Harmonization
    • Monographs
      • DS and DP
    • Discussion on Monographs (30 min)
      • Ds and DP
      • Flexible Monographs
      • Monograph Redesign
  • Reference Standards (5 min)
  • Conformance to USP (25 min)
    • Procedures
      • Verification of USP Procedures
      • Minor modifications
      • Alternative procedures
    • Reference Standards
      • USP Reference Standards
      • Secondary or Alternative Standards

Part 2:  Managing and Influencing Change

  • PF (15 min)
    • Now free on-line
    • Portal to change
    • Sections
  • How to influence USP (40 min)
    • Submit monographs or revisions
    • Submit comments to PF content
    • Volunteer
    • Attend meetings
      • User Forums
      • Workshops
      • Science & Standards Symposia
  • Current Hot Topics (45 min)
    • Monograph Modernization
    • Dissolution Performance Verification Test and Toolkit
    • Elemental Impurities
    • Heparin
    • USP Standards for PET Drugs—Chapter <823>
    • Quality Standards for Widely Used Medicines Strengthened
  • Attendee Questions and Answers (20 min)

 

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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