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 Understanding the Regulation 21 CFR Part 11 (1 Day) Training, seeks to demystify misconceptions and beliefs on what it means for companies.

So if you want to understand how 21 CFR Part 11 is now being applied, how the EU GMP Annex 11 compares and how GAMP® has provided an interpretation of the revised guidance issued in 2003, then why not attend our course?

• Understand what the regulation 21 CFR Part 11 is
  • What the requirements are
  • Why have the 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?
  • Premises and equipment
• 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
• Describe the GAMP® approach to 21 CFR Part 11 compliance
  • Links with GAMP® and risk assessment
  • Use GAMP® risk assessment to assess a potential real scenario
• Recall problems encountered by companies applying the rule
  • Potential problem areas
  • Case studies
  • Differing scenarios/FDA warning letter reviews

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

"Trainer displayed great knowledge and flexible approach."
Elekta 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

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 ›