Global regulatory expectations for approaches to process control and validation are changing. It is essential that those involved with and responsible for process validation attend a special PDA Process Validation Workshop to learn about the US FDA Guidance, Process Validation: General Principles and Practices that was published in January 2011. This guidance approaches process validation from a life cycle perspective and incorporates the current thinking of the US FDA on the stages of process validation; process design, process qualification and continued process verification. The tools and concepts of statistics, risk management and quality systems will be addressed. Also the latest on the European Medicines Agency (EMA) viewpoints on process validation and regulatory submissions will be included. PDA Technical Report (TR) 60 contents are being finalized with regulatory input and are planned for discussion as well.
2013 PDA/FDA Process Validation Workshop
20 - 21 May 2013, Bethesda, United States
Introduction
Venue
Hyatt Regency Bethesda
Hyatt Regency Bethesda, One Bethesda Metro Center (7400 Wisconsin Ave.), Bethesda, 20814, United States
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