Workshop Details

Dates

August 22, 2024

Time

3:00 pm – 4:00 pm

Cost

CAD $99.00 + HST

Location

Online

Deadline

August 15 , 2024

Workshop Overview

Navigating the United States Pharmacopeia (USP) is crucial for professionals in the pharmaceutical, cannabis, and herbal drug industries. Despite its importance, many find the USP difficult to interpret without prior experience. This webinar aims to demystify the USP, providing practical guidance for QA reviewers, QC chemists, new science graduates, and industry professionals.

By breaking down general chapters, product monographs, reagents, indicators, solutions, and general notices, participants will gain a comprehensive understanding of USP’s structure and application. Real-life case studies will illustrate effective documentation review, equipping attendees with the skills to navigate USP confidently and accurately.

Join us to enhance your knowledge and streamline your work processes with actionable insights from industry experts.

Who Should Attend​

This webinar is designed for quality assurance reviewers, quality control chemists, science graduates, and industry professionals who work within the pharmaceutical, cannabis, and herbal drug industries. It is particularly beneficial for those responsible for ensuring product quality and compliance with USP standards. Additionally, anyone interested in gaining a deeper understanding of the USP’s structure and application will find this training invaluable for enhancing their professional expertise and effectiveness in documentation review and regulatory compliance.

Workshop Outline

Introduction to USP

  • Understanding the role and significance of USP in the industry
  • Overview of USP’s history and its evolution

General Chapters

  • Structure and purpose of general chapters
  • Key chapters relevant to various industries
  • Interpretation and application in daily operations

Product Monographs

  • Understanding monographs: structure and components
  • How to read and interpret monographs
  • Case studies on product monograph reviews

Reagents, Indicators, and Solutions

  • Overview of reagents, indicators, and solutions section
  • Key reagents and their applications
  • Interpretation and usage guidelines

General Notices and Requirements

  • Purpose and scope of general notices
  • Key requirements and how they affect product compliance
  • Case studies on applying general notices in documentation review

Case Studies

  • Real-world examples of documentation review
  • Practical tips for effective USP navigation
  • Interactive exercises to reinforce learning

Learning Outcomes

Comprehensive Understanding of USP:

Gain a thorough understanding of USP’s structure and components, enhancing your ability to navigate and utilize the pharmacopeia effectively.

Interpreting General Chapters and Monographs:

Develop skills to accurately interpret and apply general chapters and monographs in various industry contexts.

Review Preparations of Reagents, Indicators, and Solutions:

Learn the correct usage and interpretation of reagents, indicators, and solutions within the USP framework.

Applying General Notices and Requirements:

Understand the importance of general notices and requirements and learn how to apply them to ensure product compliance.

Case Study Mastery:

Analyze real-world documentation to reinforce understanding and application of USP guidelines, preparing you for practical industry challenges.

All participants will receive a certificate of attendance upon completion of the workshop.

Note: Registration closes one week prior to the start of workshop.

Navigating the USP: Practical Guidance for QA, QC and Industry Professionals

August 22, 2024

Other Workshops Available

Kevin Mueller

Pharma, Cannabis

Kevin has over 25 years of pharmaceutical industry experience working for Novopharm Ltd. and Teva Canada Ltd. For 19 years, he was a supervisor in the following areas: Analytical Research and Development Stability, Quality Control Finished Product, Quality Control Stability, Quality Control Method Transfer, and Operational Excellence. Kevin is known as a positive person with an ability to motivate and guide people to reach their potential. He has demonstrated expertise in compliance, data integrity, laboratory investigations, root cause problem solving, recommending and implementing corrective and preventative actions (CAPAs), and continuous improvement of documentation and efficiency.

Kevin graduated from the University of Western Ontario with a M.Sc. in chemistry and has a yellow belt in Operational Excellence. In his spare time, Kevin enjoys long distance running.