At the PDA 2011 Analytical Methods Development & Validation Workshop case studies will be discussed to illustrate how analytical method lifecycle steps (development, qualification, validation, verification, comparability, transfer and post-validation maintenance) can build on each other. Specifically, the workshop will feature a case study illustrating the representative method lifecycle.
Additionally, participants will receive a wide overview of the laboratory and documentation standards expected during the development, qualification and validation of analytical methods. An update from last year's meeting will be presented in context to current recommendations for appropriate development and validation of methods in accordance to ICH, Pharmacopeia, PDA Technical Reports and other relevant Regulatory Documents.
This workshop offers an excellent opportunity to interact with fellow analytical development & validation professionals, regulatory representatives and leaders from around the world, in the pharmaceutical and biopharmaceutical industry. Attendees at this workshop will gain practical information on regulatory expectations and current industry best practices for the development and validation of analytical methods for biopharmaceutical products.
Click here to view the program agenda for more details.
Additionally, participants will receive a wide overview of the laboratory and documentation standards expected during the development, qualification and validation of analytical methods. An update from last year's meeting will be presented in context to current recommendations for appropriate development and validation of methods in accordance to ICH, Pharmacopeia, PDA Technical Reports and other relevant Regulatory Documents.
This workshop offers an excellent opportunity to interact with fellow analytical development & validation professionals, regulatory representatives and leaders from around the world, in the pharmaceutical and biopharmaceutical industry. Attendees at this workshop will gain practical information on regulatory expectations and current industry best practices for the development and validation of analytical methods for biopharmaceutical products.
Click here to view the program agenda for more details.
