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Who Can Benefit from 2-Session Web Training Curriculum:

 

This course is intended for:

 

  • Production Quality Personnel
  • Management
  • Validation Personnel
  • Engineering Personnel

 

 


 

Learning Benefits of 2-Session Web Training Curriculum:

 

  • How a master plan can help you
  • Necessary validation activities required
  • Relevent GMP/ cGMP  programs
  • How to implement the required programs

 

 

  
Speaker: Jerry Holatko
 
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The ‘Master Plan’ lecture series features discussion of all programs necessary for making your pharmaceutical facility controlled and compliant. The series will help define areas of responsibility for various groups, help you to implement the best practices to meet compliance, and also guide validation personnel to successful project completion.

 

Points to be Covered:

 

Session 1 (October 7, 2008):

 

  • Introduction and overview
  • Validation
  • Facility design
  • Material qualification
  • Equipment Qualification
  • Utilities
  • Required protocols
  • SOPs

 

Session 2 (October 8, 2008):

 

  • Environmental Monitoring
  • Calibration program
  • Training
  • Stability
  • Maintenance
  • Change control
  • Document control
  • Manpower Requirements

 

 

 

 

Areas of Expertise

 

  • Project Management
  • Quality Systems implementation
  • transportation validation
  • GMPs
  • Food and Drugs Act and regulations

 


 

Speaker Bio

 

With a B.Sc. in Chemistry, Jerry brings over 30 years of senior management experience in regulatory and consulting positions working with Health Canada and PharmEng Technology, Inc.

 

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For registration deadlines and pricing information, please   click here

 

For the complete 2 Session Series schedule, please    click here

 

 

Copyright 2009 BenAstrum