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ISPE/PQRI Process Validation Conference

September 11, 2015 by
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Comply with the FDA PV 2011 Guidelines and get your products to market faster with Validation Automation.

Date: Oct 7th

Time: 6-8pm (beverages included)

Description:

This discussion with experienced Pharmaceutical professionals will simplify, strengthen, and complete your knowledge of implementing, as well as automating the requirements set forth in the new FDA’s Guidance on Process Validation.

During the presentation, you will hear firsthand from industry leaders on the approach and related experiences transitioning from historical Process Validation strategies to meet the new 2011 guidelines. Walk away with practical solutions and be equipped with the right information and tools to plot your company’s path towards a successful implementation of current validation principles and technologies. See ground-breaking innovations happening inside brand name pharmaceutical companies that can shorten production schedules and keep your team well ahead of Process Validation 2011 Guidelines.

Outline for Event:

  • Introduction
  • PV Guidance: Business Drivers
  • Key Elements
  • Risk Assessment- methodology
  • Statistical Analysis Tools- examples/case study
  • Continued Process Verification- rules and steps
  • Knowledge Management across Stage 1, 2, 3
  • Challenges/Implications of bespoke process, disconnected tools
  • Application of PV Validator to realize above goals- CA Demo

Target Audience:

This event is ideal for personnel in product/process development, manufacturing, validation, QA, and QC involved in process validation and process control.

Audience members will walk out with the following three actions/items to consider as they think about PV in 2016

  • Comprehensive method to implementation of lifecycle approach to process validation
  • Awareness of advancement in technologies geared to facilitate, and automate activities and deliverables to be performed as per the new guidelines.
  • Benchmark of their current programs and the necessary resources to generate a business case for consideration in their individual organization.

For more information about the event, click here.

Seats are limited. Don’t delay – reserve your spot today!

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