topleft
topright

 

Register

 

Web Seminar Agenda:

 

1:00 – 1:20  Login & Setup
1:20 – 1:30 Introduction
1:30 – 2:30 Presentation
2:30 – 2:45 Final Notes
2:45 – 3:00 Break 
3:00 – 3:30 Q&A
  

Eastern Daylight Time

 


For a complete pricing structure, please click here 

 

Early Bird Deadline:

Friday, June 6, 2008
 
Registration Deadline:

Monday, June 16, 2008

 

 


 

Who Can Benefit:

 

This course will benefit pharmaceutical professionals working in the following domains:

 

  • Quality Assurance
  • Quality Control
  • Quality Engineering
  • Regulatory Affairs
  • Operations
  • Validation

 

 

 

 

Speaker: Charles Gyecsek
 
PDF Print E-mail

 

A Validation Master Plan is not a mandatory document, but is usually one of the key documents an auditor will ask to review.  It is a document that dictates the way a company approaches validation, identifying who has control over the various aspects of the validation activities, and how production, quality, and management will be involved.  The VMP also establishes the validation requirements for each test/system/equipment and will guide the organization in achieving its objectives.

 

This live and comprehensive web seminar will provide an introduction to the creation, implementation and maintenance of Validation Master Plans.

 

Key Discussion Points will include:

 

  • What is a VMP?
  • Why is a VMP valuable to my company?
  • What is defined in the VMP?
  • How is the VMP controlled and updated?
  • How is the VMP implemented?
  • Who contributes to the VMP?

 

Learning Benefits:

 

Upon completion of this course, participants will have a better understanding of:

 

  • Identifying the validation concerns for your company
  • Identifying the validation requirements for your company
  • Establishing a written plan
  • Taking a holistic approach to validation
  • Achieving synergy among validation programs
  • Providing clear guidance to your organization

 

 

 

Areas of Expertise

 

  • Plant start-up
  • Cleanroom design and renovation
  • Quality system auditing
  • Regulatory submission writing

 


 

Speaker Bio

 

Currently the President of MIJ Enterprises, Charles Gyecsek brings many years of experience working previously in the Validation, Microbiology and Quality departments at Hoffman Laroche.

 

More>>>

 


 

Sponsorship

 

During each webinar, a 15-minute break period will be allotted for companies to promote new products and technologies in today's fast paced environment. 

 

More>>>

 

Copyright 2009 BenAstrum