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I joined ISPE with the hope of giving something back to an industry that has served me well over the last 15 years. After attending one conference, I knew I wanted to become an active Member in the organisation. I wanted to have a role in ISPE activities and events that benefited other industry Members. I found the transition from attendee to active Member relatively easy. Despite the fact that ISPE is a society made up of volunteers, passion and professionalism in which business was conducted was eye opening. In my 10 years as a Member, I have made many friends who have afforded me the benefit of their experience within OUR industry and have changed both my professional and social view point. ISPE is a wonderful organisation and I hope to be part of it for years to come.

Nigel Frost, Managing Director
Thermal Transfer, Ltd., United Kingdom

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Training

Validation Documentation

ISPE CEUs*: 1.2
Type: Classroom Training Course

Upcoming Dates and Locations

Date

Location

Country

Instructor(s)

This course is not currently scheduled, but may be conducted on-site. Please contact ISPE Customer Service.

Description

This course will provide participants with fundamental principles of validation documentation. The course will address the different types of documentation, the purpose of each document type, and how the documents are utilized by the FDA for ensuring compliance to GMPs. The course will provide samples of document types and give the student case study examples of how documents are developed and completed.

Take Back Your Job

  • Identify various types of validation documentation
  • Understand the content of each document type and its importance to the validation effort
  • Develop sample documents
  • Review documents for accuracy and content
  • Identify documents to be included in Validation Master Plans
  • Execute a formal documentation review
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