In this FDA compliance training learn regulatory expectations for stability indicating methods & Purpose and requirements for stability indicating methods. There is a lot of concern related to the stability of various drugs over different periods of time and different companies are following different approaches to this problem.
Why Should You Attend:
Stability indicating methods are quantitative test methods that can detect changes with time of drug substances and drug products. Information of type and amount of degradation products over time is important for safety of drugs. Therefore, FDA and other agencies but also good business practice requires such methods to be well designed and validated.Areas Covered in the seminar:
- Regulatory expectations for stability indicating methods.
- FDA Warning Letters and how to avoid them.
- Business and compliance reasons for stability methods.
- Purpose and requirements for stability indicating methods.
- Planning for development.
- Design meaningful stress conditions.
- Procedures and measurement of forced degradation.
- Special storage conditions.
- Strategies for validation.
- Staged validation approach during development.
- Validation experiments.
- Practical hints for validation experiments.
- Documentation for FDA/EU GMP compliance.
Who Will Benefit:
- QA managers and personnel
- Analysts and lab managers
- Managers and staff of stability testing labs
- Validation specialists
- Training departments
- Documentation department
- Consultants
- GMP/GCP auditors
- Teachers
Course Provider
Dr. Ludwig Huber,
