Course offering number:0908-703
Course ID:
2325
GO BACK TO BROWSE ONLINE TRAINING COURSES PAGE
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
Auditing for GMP Compliance
Mar 27 2012, Amsterdam, The Netherlands
cGMP Auditing - Strategies for Compliance
Conducting Effective Quality Audits
Documentation Management and Control
Mar 05 2012, New Brunswick, NJ
Documentation Management and Control
Jun 07 2012, Amsterdam, The Netherlands
Introduction to cGMP System-Based Audits
AN ON-DEMAND ONLINE TRAINING FORMAT
Managing FDA Inspections: the FDA investigator cometh...are you ready?
FREE On-Demand Webinar
Preparing for and Surviving an FDA Inspection
Setting up and Implementing Vendor and Supplier Audits
FREE On-Demand Webinar
Strategies for Setting up and Implementing Supplier Audits
Mar 07 2012, New Brunswick, NJ
Strategies for Setting up and Implementing Supplier Audits
Jun 11 2012, Amsterdam, The Netherlands
Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites
Jun 05 2012, Amsterdam, The Netherlands