The American regulation 21 CFR Part 11: Electronic Records; Electronic Signatures has been one of the most significantly difficult regulations for healthcare manufacturers to understand and implement since its conception and authorisation in 1997.  The Interpreting the Regulation 21 CFR Part 11 and revised EU Annex 11 (1 Day) Training Course, seeks to demystify misconceptions and beliefs on what it means for companies.

The course also provides a review and comparison of Part 11 with Annex 11 and related EU GMP Volume 4 Chapter 4 on Documentation.

So if you want to understand 21 CFR Part 11, what has been revised in the EU GMP Annex 11 and Chapter 4, and examine the GAMP®’s interpretation of the guidance, then why not attend our course?

• Understand the regulation 21 CFR Part 11
  • What the requirements are
  • Why is the regulation necessary?
  • The difference between guidance and regulation
• Identify key terminology used in the regulation
  • Terms and definitions
• Lifecycle of a document
  • Electronic
  • Hard copy
  • Records
• What is in and out of scope?
• Validation requirements for computer systems
• Predicate regulations - what are they, where to look and why?
• A focus on risk to records and the 'Hybrid' approach
• Links to validation
  • Validation requirements for computer systems
• Training
  • Requirements
  • Qualifications and experience
• Management of systems
  • For open and closed systems
  • Physical and logical controls
• Signatures
  • Signature/record linking
  • Their uniqueness
  • Biometrics
• Controls
  • Password ageing
  • Procedures
  • Management responsibilities
• Understand FDA Part 11 Guidance for Industry
  • Latest thinking and guidance
  • Why the FDA is now assessing whether companies are using its revised guidance
• Recall problems encountered by companies applying the rule
  • Potential problem areas
  • Case studies
  • Differing scenarios/FDA warning letter reviews
  • Comparison between how the FDA used to audit and report compliance issues and how it is now
• Identify and review EU GMP Annex 11 revised guidance on Computerised Systems focusing on records and signatures
• Review includes:
• Corresponding GMP Volume 4 Guide, revision of Chapter 4 Documentation
• Updates from previous revision of Annex 11
• Cross reference to Part 11
• Describe the GAMP® approach to 21 CFR Part 11 compliance
• Links with GAMP® and risk assessment
• Review examples from the guide
• Use GAMP® risk assessment to assess a potential real scenario

ISPE owns the GAMP® trademark http://www.ispe.org/

This course can be delivered to a group of up to 12 delegates at your premises. Request a quote for an onsite course.

ITS offers onsite training courses delivered by an English-only speaking trainer for companies in Europe and Worldwide. ITS has delivered courses to delegates from a number of countries including Belgium, France, Germany, Ireland, Jordan, Russia, Sweden and Switzerland.

"Trainer was excellent."
Orthoplastics Ltd

"Very well organised, time managed and delivered."
Orthoplastics Ltd

"Trainer displayed great knowledge and flexible approach."
Elekta Ltd

"Good proactive course."
Orthoplastics Ltd

"Dry subject well presented."
Elekta Ltd

"Trainer made interaction very easy."
Elekta Ltd

“Excellent really assisted in my understanding.”
ABB

“Will definitely use the facts covered in my work environment.”
Covance Laboratories

“Very good background information to help me understand GAMP® and 21 CFR Part 11.”
Norgine Ltd

“Very useful course.”
Sauflon Pharmaceuticals Ltd

“Class size small, so lots of questions and answers...Excellent course, very worthwhile.”
Olympus Surgical Technologies Europe

“Well presented. Topics explained clearly.”
Biochrom Ltd

“Good detailed material. Course material clear and well presented.”
Biochrom Ltd

ITS’ Regulatory Training Manager, Alan Benbow, has developed extensive knowledge of this specialist area from 22 years’ industry experience working with Johnson & Johnson, and Wyeth Pharmaceuticals.

During his 14 years at Wyeth, Alan was involved in a wide range of activities including, at operational levels, developing operators, craftsmen, and technicians; he was also responsible for training and assessing operational employees to NVQ standards. From a mid-management perspective, training and development initiatives included facilitating continuous improvement projects and best practices, and receiving internal recognition awards. more ›