This Validation training on Analytical methods will give specific recommendations on how to plan, conduct and document analytical method validation for efficient FDA, USP and ISO 17025 Compliance.
Why Should You Attend:
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.
Reference Material:
For easy implementation, attendees will receive
- 3 SOPs
- Validation of Analytical Methods
- Transfer of Analytical Methods
- Verification of Compendial Methods
- Checklist: Validation of Analytical Methods
Areas Covered in the Seminar:
- FDA regulations and guidelines.
- Examples of warning letters and recommendations how to avoid them.
- Requirements of ISO 17025.
- Developing an SOP for method validation.
- Development of a validation plan.
- Defining parameters and acceptance limits.
- Validation of standard and compendial methods.
- To revalidate or not after method changes.
- Transferring a method to routine.
- Using software for automated method validation.
- Documentation for the FDA, other agencies and for ISO 17025.
Who Will Benefit:
- By Laboratory/Industry
- Pharmaceutical development and quality control laboratories
- Food, environmental, clinical and chemical testing laboratories
- Contract laboratories
- By function
- QA managers and personnel
- Analysts and lab managers
- Validation specialists
- Training departments
- Documentation department
- Consultants
Instructor Profile:
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. For more information, visit Dr. Huber’s website: www.ludwig-huber.com
