Analytical Methods Development & Validation Workshop 2013
conferencias > Advanced Materials, Composites conferencias > Analytical Methods Development & Validation Workshop
March 18 - 19, 2013
Baltimore MD , Estados Unidos
SPECIAL OFFER! All paid workshop attendees will receive a FREE electronic copy of PDA Technical Report No. 57: Analytical Method Validation and Transfer for Biotechnology Products
The 2013 PDA Analytical Methods Development and Validation Workshop will bring together industry professionals of all levels to network and benefit from updates on recent regulatory guidance's regarding developing and validating analytical methods. The workshop will provide participants with a comprehensive review of laboratory and documentation standards expected during the development, qualification, validation, and transfer of analytical methods. Case studies will be discussed to illustrate how analytical method lifecycle steps (development, qualification, validation, verification, comparability, transfer, post-validation maintenance, etc.) can build on each other within the biotechnology product life cycle. The workshop will also include a discussion of current recommendations for appropriate method development and validation in relation to ICH, Pharmacopoeia, PDA Technical Reports, and other relevant Regulatory Documents.
The 2013 PDA Analytical Methods Development and Validation Workshop will bring together industry professionals of all levels to network and benefit from updates on recent regulatory guidance's regarding developing and validating analytical methods. The workshop will provide participants with a comprehensive review of laboratory and documentation standards expected during the development, qualification, validation, and transfer of analytical methods. Case studies will be discussed to illustrate how analytical method lifecycle steps (development, qualification, validation, verification, comparability, transfer, post-validation maintenance, etc.) can build on each other within the biotechnology product life cycle. The workshop will also include a discussion of current recommendations for appropriate method development and validation in relation to ICH, Pharmacopoeia, PDA Technical Reports, and other relevant Regulatory Documents.
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Analytical Methods Development & Validation Workshop March 18 - 19, 2013