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Validation and cGMP Compliance Week Puerto Rico

Achieve Manufacturing Excellence through Optimal Quality Practice

July 12-14, 2011

IVT has been at the forefront of promoting validation and GMP initiatives since its inception in 1994. Validation and GMP Week Puerto Rico is a three-day event and exhibition bringing together quality, validation and regulatory representatives who present their experiences in the validation and GMP compliance within three cutting edge tracks – Validation, Quality Systems and Laboratory Controls. This case-study driven event includes workshops on implementation strategies for these specific areas of compliance. Participants have the opportunity to create their own conference by staying in one track or crossing over between tracks for an optimal training experience.

Main issues to be addressed:

  • Develop, Implement and Maintain Risk-based Process Validation Practices
  • Implement a Modern, Robust Quality System Using ICH Q10 as a GuidepostDevelop a GMP Roadmap for Laboratory Compliance           
  • Develop an Effective Validation Master Plan (VMP)
  • Using Effective Risk Management Strategies           
  • Implement a Compliant Stability Program           
  • Establishing Acceptance Criteria in Process Validation           
  • Build in Quality by Design from the Development Phase and Throughout a Product’s Lifecycle
  • Execute Effective Analytical Method ValidationUnderstand, Reduce and Control Variation
  • Implement Best Practices for Change Control Systems           
  • Control Microbial Contamination