Compliance Trainings, Online
2015-12-09
Description : Using the QbD approach for development and validation will result in more robust analytical methods. Advantages are easier method transfer, longer revalidation cycles and fewer or no methods specific Out-of-Specification situations when used in routine. In addition, FDA, USP and international agencies promote the QbD approach because it is expected that such performance based routine methods can be changed within the analytical target profile (ATP) without regulatory resubmission and approval. Moreover, the new FDA Method Validation Guide suggests using QbD elements for development and validation. Because there is no or little experience with the QbD approach for analytical methods, the industry has many questions. For easy implementation, attendees will receive: Master plan - Template and examples: Development and Validation of Analytical Methods through QbD SOP - Development and Validation of Analytical Methods through Quality by Design Checklist - Validation of Analytical Methods according to the FDA Guidance 2015 Areas Covered in the Session : General principles and key benefits of QbD Regulatory background and trends: FDA, ICH Q8/9/10 Reasons for changing the way we validate methods Current applications of QbD in the pharmaceutical industry The Application of QbD for analytical methods Comparison of the QbD process with ICH Q2 and USP <1225> Benefits for method transfer and routine use Using the lifecycle approach for method design, development and validation Developing specifications and, the analytical target profile Documenting input variables for risk assessment in fishbone diagrams Using the risk assessment prioritization matrix to select the test parameters Traditional vs. the QbD process for method parameter optimization The method validation and qualification studies Using the method in the routine: on-going performance control, review and change control Continuous monitoring and improvements Documentation requirements Defining the Analytical Target Profile (ATP) and design space Case studies Who Will Benefit: A must attend webinar for professionals in Pharmaceutical and medical device industry, Manufacturers of drug substances (APIs) and Contract laboratories, Contract manufacturing organizations, Clinical research organizations. The teams that will benefit the most are: QA Managers and Personnel Analysts and Lab Managers Regulatory Affairs Training Departments Method Development Departments Documentation Departments Consultants
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