Validation of Analytical Methods and Procedures - Design, Conduct and Document for Efficiency and Compliance

This Validation training will guide attendees through the entire process from defining specifications, through developing and implementing validation experiments to FDA compliant documentation.

Why Should You Attend:

Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented. This seminar will guide attendees through the entire process from defining specifications, through developing and implementing validation experiments to FDA compliant documentation.

What Attendees will Learn:

• FDA regulations and guidelines
• Developing an SOP for method validation
• Development of a validation plan
• Defining parameters and acceptance limits
• Validation of standard/compendial methods
• Change control and revalidation
• Transferring a method to routine or other sites
• Using software for automated method validation
• Documentation for the FDA and other agencies

Who Will Benefit:

Everybody involved in the validation of analytical methods.

• Analysts and lab managers
• QA managers and personnel
• Validation specialists
• Regulatory affairs
• Documentation department
• Consultants