Analytical Method Validation Agenda

DAY ONE

8:00 a.m. – 9:00 a.m.

Registration/Continental Breakfast

9:00 a.m. – 10:00 a.m.

  • Performing and documenting an analytical method validation, from writing a protocol to execution, through final method validation summary report
  • Overview of analytical validation requirements that detail:
    • Regulatory expectations
    • Validation prerequisites
    • Verification versus validation
    • Reverification
    • Revalidation
  • Compilation and evaluation of data
  • Putting it all together into a comprehensive, compliant method validation summary report

 

10:00 a.m. – 12:00 p.m.

  • INTERACTIVE EXERCISE! Compendial methods — understand the expectations to ensure that the method is “suitable for its intended use”
  • Distinguish between the requirements for verification and validation
  • Understand when a verification is applicable and when a validation is required
  • Qualitative methods — how to ensure “suitability for intended use”

 

12:00 p.m. – 1:00 p.m.

Lunch

1:00 p.m. – 2:30 p.m.

  • Define technical transfer approach using verification requirements
  • Examine five real-world method modification examples, as well as the decision process for revalidation and the key elements for executing the protocol
  • INTERACTIVE EXERCISE! Identify when a revalidation is required after modification(s) to the test method

 

2:30 p.m. – 5:00 p.m.

  • Method validation characteristics
  • Define requirements for validation
  • INTERACTIVE EXERCISE! Best practices for executing a method validation
  • Understand the process for documentation and investigation of any deviation and/or protocol exception that occurs during the validation activities

 

DAY TWO

8:00 a.m. – 8:30 a.m.

Continental Breakfast

8:30 a.m. – 11:00 a.m.

  • Strategies for how to avoid the five common validation “pitfalls”
  • Understanding the stability indicating method and its uses
  • INTERACTIVE EXERCISE! Handling of out-of-specification test results and protocol exceptions

 

11:00 a.m. – 12:00 p.m.

  • Define regulatory expectations of a validation protocol
  • Understand the difference between an analytical method, microbiology, bioanalytical validation protocol

 

12:00 p.m. – 1:00 p.m.

Lunch

1:00 p.m. – 3:30 p.m.

  • INTERACTIVE EXERCISE! Create a validation protocol for test method validations applying:
    • Analytical instrumentation (i.e., HPLC, GC, FTIR)
    • Non-instrumentation (i.e., TLC, Karl
    • Fischer, residue on ignition)
    • Microbiology (microbial limits test)
    • Bioanalytical
    • Identifying validation characteristics
    • Determination of acceptance criteria

 

3:30 p.m. – 5:00 p.m.

  • INTERACTIVE EXERCISE! Organize your thoughts as the first step in creating an analytical method validation summary report
  • Details on the 16 items that must be documented in an analytical method validation summary report
  • Synthesize technical writing guidelines to create a concise report
  • Question the information to ensure content is compliant (meets all regulatory requirements), accurate and easily understood
  • Key Elements
    • Organization
    • Presentation of data
    • Validation summary
    • Out-of-specification/protocol exceptions
    • Review/approval
    • Describe the contents of the final package
    • Explain why the final package, which includes the analytical method validation summary report and all supporting data, must be self-explanatory

 

5:00 p.m.

Adjourn