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
Other Courses of Interest
Applied cGMPs for Pharmaceutical and Allied Industries
Mar 01 2010, Burlingame, CA
Auditing for cGMP Compliance
Jun 17 2010, Amsterdam, The Netherlands
Conducting Effective Quality Audits
Mar 17 2010, Amsterdam, The Netherlands
Documentation Management and Control
Feb 22 2010, New Brunswick, NJ
Documentation Management and Control
Mar 22 2010, Amsterdam, The Netherlands
Introduction to cGMP System-Based Audits
AN ON-DEMAND ONLINE TRAINING FORMAT
Pharmaceutical Quality Assurance and Control
Preparing for and Surviving an FDA Inspection
Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites
Jun 15 2010, Amsterdam, The Netherlands