Using Electronic and Digital Signatures in Regulated Environments

Why Should You Attend:

FDA Part 11 and other regulations such EU GMP Annex 11 allow to sign electronic records with electronic and digital signatures. Benefits for regulated user firms are increased overall efficiency and reduced costs for handling and storing paper records. While nearly all Part 11 related papers and seminars deal with requirements of electronic records there is hardly any information about electronic and digital signatures. Therefore most companies are unsure about electronic signatures such that they print out copies of electronic records and sign the paper.

In this seminar attendees will become familiar with FDA requirements for electronic and digital signatures.

Areas covered in this webinar:

• Definitions of electronic vs. digital signatures.
• Benefits of electronic signatures.
• Examples of using e-signatures day-by-day.
• Part 11 requirements for electronic signatures?
• European and international requirements.
• Applications and requirements of digital signatures.
• Inspection and enforcement practices.
• Specific software requirements for electronic signatures.
• How to document the meaning of the signature.
• Using digital pens for electronic signatures.
• Validation of electronic signature software.
• Certification of electronic signatures for the FDA.
• FDA compliant training of accountability for e-signatures.
• Using electronic signatures in Excel.

Who Will Benefit:

Pharmaceutical and medical device manufacturers, clinical contract reasearch organizations, contract laboratories and API manufacturers will benefit.

• Everybody using computers in FDA regulated environment
• Part 11 groups in Bio(pharmaceutical) and device industry
• System owners
• Software developers
• IT managers and system administrators
• QA managers and personnel
• Analysts and lab managers
• Training departments
• Documentation department
• Consultants
• Regulatory affairs

Instructor Profile:

Ludwig Huber , Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance for Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare.

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