Efficient Method Transfer in Pharmaceutical Analysis

Overview:

The transfer of analytical procedures is a frequent activity during the lifecycle of a drug substance or drug product. Thus, it is always in the focus of audits and inspections. According to US 21 CFR 211.194 and the EU GMP guide, QC laboratories which did not perform the original validation should verify the appropriateness of the testing method. Analytical transfer is also discussed in the new ICH Guidelines Q2(R2) and Q14, the General Information Chapter of USP <1224>, and other guidelines. 

Why you should Attend:

The webinar provides regulatory requirements and recommendations with respect to the transfer of analytical procedures. Transfer can be regarded as the ultimate robustness check of an analytical procedure. Aspects neglected or missed during method development will often become evident. Therefore, a meticulous planning and design, as well as a prudent management of issues during the transfer are vital and can ensure an efficient transfer with increased probability of success.

Areas Covered in the Session:

• Regulatory requirements and recommendations
• Analytical transfer as part of the lifecycle management 
• Management of the transfer process (transfer team, documentation, strategy, protocol, training, report) 
• Establishment of an efficient transfer strategy
• Design of experimental studies 
• Transfer acceptance criteria (accuracy and precision)
• Evaluation of results (simple and statistical comparison) 
• Root causes of issues during transfer
• Management of deviations, suspect and out-of-specification results

Who Will Benefit:

• Analysts
• Lab Supervisors and Managers in Analytical Development
• Quality Control, or Quality Assurance who want to gain a better Understanding of the GMP Requirements and Regulatory Expectations with Respect to Method Transfer, and are Interested in an Efficient Planning, Execution, and Evaluation of Transfer Activities to Facilitate a Successful Method Transfer