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Course offering number:0908-703

Course ID:
2325
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An Overview of Documentation Requirements in FDA Regulated Industries
In Conjunction with Wiley-Blackwell
Pre-recorded Course

AN ON-DEMAND ONLINE TRAINING FORMAT

Who Should Attend
This overview online presentation will benefit professionals in various functions in the pharmaceutical, medical device, biotech and related industries, who are responsible for the writing, implementation or management of various types of documents. These functions include:

  • Pre-clinical operations
  • Manufacturing processes
  • Regulatory
  • Clinical operations
  • QA/QC
  • Documentation writers/managers
  • Laboratory operations
  • Auditors

Description
This 90-minute accredited training course presents an overview of the main types of documents required in FDA regulations and guidances, in ICH guidelines and in ISO 9000. Based on industry best practices, this presentation will discuss ways to classify documents and will clarify the distinction between controlled and non controlled documents. The transition from manual systems to electronic systems and the impact of 21 CFR Part 11 upon documentation will conclude the course. Please note that details about the management and control of documents, and documentation systems are discussed in other technical public courses offered by CfPA.

Module 1: Requirements for written documentation as identified in:
  • 21 CFR Part 211–cGMP for Finished Pharmaceuticals
  • Quality System Regulations–QSR
  • 21 CFR Part 58–Good Laboratory Practice
  • FDA Guidances
  • ICH Q7–GMP for Active Pharmaceutical Ingredients
  • Quality System Standards–ISO 9000

Module 2: Role of documentation and examples of main documentation types in:
  • Pre-clinical operations
  • Clinical operations
  • Manufacturing processes
  • Laboratory operations

Module 3: Impact of 21 CFR Part 11–Electronic Records and Signatures:
  • Moving from a manual system to an electronic system
  • Basic documentation requirements
  • Need for validation
  • Availability of documents during FDA inspections

Question and Answer Session




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