Validation Master Planning and Regulatory Expectations - Webinar

  • ID: 4428063
  • Webinar
  • 60 Minutes
  • NetZealous
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Our Speaker will explain the expectations of regulatory authorities both domestic and international. You should attend if you are not familiar with the activity or would like to understand the expectations both foreign and domestic.

This presentation will cover the importance of master planning. The FDA and other regulatory bodies expect these to be among the Quality System documentation. How best should it be implemented and maintained? What are the types and how many should there be? This presentation will delve into the detail of development and presentation. It will also cover some of the do's and don'ts as well as view point of an auditor.

Areas Covered in the Session:
History and background
Types
Organization
Requirements
Regulatory expectations
Maintenance
Use
Upkeep
PICs guideline
2011 requirements
Do's and don'ts
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  • Louis Angelucci Louis Angelucci,


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  • Managers, Supervisors, Directors, and Vice-Presidents
  • R&D
  • Manufacturing Engineering
  • Design Assurance
  • Quality Assurance
  • Operations
  • Document Control
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