Source: http://gmpcompliance.net/Training/Part_11_Compliance.htm
Timestamp: 2018-12-13 08:26:19
Document Index: 692448650

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

Training Seminar: 21 CFR Part 11 Compliance (Electronic Signatures, Electronic Records in FDA regulated fields)
How to Implement 21 CFR Part 11 Regulation and its Guidances
This course explains how to apply the electronic records and signatures regulation in a real world setting. It is ideal for all personnel that interact with electronic systems in an FDA regulated environment, including QA, QC, Regulatory, Manufacturing, Laboratory Services, Process Development, and all of Operations support.
This course explains all aspects of the Part 11 regulation and gives an overview of the associated Guidance Documents. It contains many examples of how the regulation can be applied using typical industry scenarios. It also includes many quotes from FDA and FDA issued Warning Letters to show how the regulation is being applied by regulatory agencies. Risk based approaches to Part 11 are also included. The changes to Part 11 announced in February of 2003 have been incorporated into this training session.
Introduction to Part 11 Requirements
Systems Covered by Part 11
Electronic Records Requirements
Additional Open Systems Requirements
Additional Electronic Signatures Requirements
FDA Guidance Document Recommendations
Examples of Part 11 Implementation in the Real World, including
Formal Part 11 Assessment of all existing systems
SOPs for security control
SOPs for ensuring personnel accountability
SOPs for to fill in the gaps when systems are not fully compliant
Electronic Systems Investigations
Specifying Part 11 requirements when procuring/designing new systems
Spreadsheet control, validation, and security
IT is now GMP
Trends for Compliance
For "Real World" situations, examples from the following systems are incorporated:
Off-The-Shelf and Custom Process Monitoring and Control System (e.g. chromatography skid, utility and building monitoring)
Spreadsheets (e.g. Environmental Monitoring data)
Custom Database (e.g. investigations tracking)
Off-The-Shelf and Custom database system (e.g. sample and results tracking)
Lab Instruments (e.g. certain HPLC)
Spreadsheets (e.g. results calculation)
Custom Database (e.g. process development database)
Spreadsheets (e.g. critical parameter trending)
NOTE: A 2 hour version, abbreviated version of this course is also available. All the basics of the regulation and the guidance documents are covered, but with fewer "real world" examples.
FDA on Electronic Records
The theme of the regulations is that part of what makes electronic signatures trustworthy, are the underlying records themselves. The actual records are also important. It is just as important to have those records be trustworthy regardless of whether the records are electronically signed or not. These regulations are really for electronic records AND electronic signatures.
SQA CVIC Meeting