COURSE ID 3046

Pharmacopoeia Compliance: An Overview [FREE WEBINAR]

How to Meet Legal, Regulatory, and Compendial Requirements

AVAILABLE ON-DEMAND
Duration: 40 Minutes
Course Instructor

J. Mark Wiggins

Joseph A. Albanese, Ph.D.

Price
$ 0
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

Compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the pharmacopeia is applicable. This fundamental, and often misunderstood – principle is an important consideration throughout the drug product life cycle across the bio/pharmaceutical industry. Ensuring pharmacopoeia compliance is often complex and the challenges are unique to any given company and its product portfolio.

This Free ON DEMAND Webinar provides an overview of the interplay of pharmacopoeias and a company’s quality assurance and regulatory affairs functional areas to assist in establishing effective processes, partnerships, and tools for pharmacopeia compliance. This course can also help you determine whether additional customized training  which is available through cobbolestone could enhance your understanding and improve the approaches taken by your company to maintain appropriate and timely compliance with pharmacopoeia requirements.

Course Topics Include:

  • Why pharmacopoeia compliance is necessary and why it is difficult
  • A brief history of pharmacopoeias and harmonization efforts
  • The revision process for global and national pharmacopeias
  • The associated surveillance process used to identify changes that impact a company
  • A practical approach to compliance that addresses differences in limits and methods between a pharmacopoeia monograph and approved registrations
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This Free Webinar is intended for individuals who have the responsibility for ensuring compliance with requirements in the pharmacopoeias and is broadly applicable to the global bio/pharmaceutical industry, including innovator, generic, biotechnology, consumer-care, and related industries.

  • Compendial affairs
  • Analytical chemistry/Process chemistry
  • Regulatory affairs/CMC
  • R&D/New products/Method development
  • Quality assurance/Quality control
  • Contract manufacturers/laboratories

Course Instructor

J. Mark Wiggins

Owner and Compendial Consultant with Global Pharmacopoeia Solutions

J. Mark Wiggins’s Courses

Joseph A. Albanese, Ph.D.

Managing Director of Albanese Consulting, LLC

Joseph A. Albanese, Ph.D.’s Courses

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Team Training

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Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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