Overview:
This course is designed to provide participants with an understanding of the regulatory expectations for controlling impurities and degradants (including DNA reactive/potential genotoxic impurities) in drug substances and drug products. There will be ample opportunity to discuss questions and challenges from the participants.
Why you should Attend: Upon completion of this course the learner should be able to:
Areas Covered in the Session:
This course is designed to provide participants with an understanding of the regulatory expectations for controlling impurities and degradants (including DNA reactive/potential genotoxic impurities) in drug substances and drug products. There will be ample opportunity to discuss questions and challenges from the participants.
Why you should Attend: Upon completion of this course the learner should be able to:
- Understand regulatory expectations regarding impurities, degradants and potential genotoxic impurities in pharmaceuticals
- Understand what specifications will conform to regulatory expectations
- Develop an process for reporting impurities and addressing OOS situations
Areas Covered in the Session:
- Landscape of impurities requiring control in pharmaceutical products
- General impurities: elemental impurities, residual solvents, microbiological
- Drug-related impurities process impurities, degradants, potentially genotoxic impurities
- Process Impurities
- Understanding ICH Q3A
- Where impurities originate
- How impurities are characterized
- How specifications are developed
- How impurities should be reported
- Degradants
- Understanding ICH Q3B
- Where degradants originate
- How degradants are characterized
- Potential genotoxic impurities
- How specifications are developed
- How degradants should be reported
- Questions and discussion
Speaker
Greg Martin is President of Complectors Consulting which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. He has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major Pharma company for a number of years.In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters - Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.
Who Should Attend
- Quality Engineers
- Manufacturing Engineers
- Internal Auditors
- Quality Specialists
- Quality Associates
- Operations and Manufacturing Managers
- Process Engineers
