Source: http://www.labcompliance.com/seminars/audio/301/default.aspx
Timestamp: 2013-05-23 00:47:32
Document Index: 495049866

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

Using Electronic Signatures in FDA and EMA Regulated Environments
Warning letters what FDA inspectors look for and what mistakes others make, so you can avoid them. Learn from FDA 483's and from detailed EIR inspection reports what FDA inspectors look for, what questions they ask and if company's response is satisfactory. 483's and EIR's typically are not available from FDA's public website.
On-line Audio Seminar 301
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. Key questions about electronic and digital signatures
What is the difference to digital signatures
What are the Part 11 requirements for e-signatures?
What are differences to other regulations, EU Annex 11
Which documents need to be signed
Are there any specific issues during FDA and other inspections
How to link signatures with records?
Are PDF signatures Part 11 compliant?
Can we use digital pens to create electronic signatures
How to 'certify' electronic signatures for FDA
How to avoid unapproved editing of e-signed documents?
How to use electronic signatures in Excel?
Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, gap analysis, implementation plan templates and examples will help immediate and cost effective implementation.
During the interactive presentation you learn:
Definitions of electronic vs. digital 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
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
- with section on electronic signatures
SOPs: - Using Electronic Signatures in FDA Regulated Environments
- Access control to computer systems and data
Gap analysis/checklist: - 21 CFR Part 11
- Using Electronic Signatures in Regulated Environments
- Requirement Specifications for Electronic Signatures
Example: Letter to the FDA about using Electronic Signature Certification
Example: Statement on Accountability for Electronic Signatures
Tutorial: Getting and using Digital Signatures for E-mails
Warning letters and Inspectional observations related to Part 11 and signatures
FDA Regulation 21 CFR Part 11: Electronic Records and Signatures
EU GMP Annex 11: Using Computerized Systems
FDA Guidelines Related to 21 CFR Part 11
Unites States: Electronic Signatures in Global and National Commerce Act (E-sign act)
NIST Guidance on Implementing the electronic signatures in global
and national commerce act (e-sign)
National Archive and Records Administration: Records Management Guidance for PKI Digital Signature Authentication and Secure Transaction Records Directive 1999/93/EC of the European Parliament on a Community framework for electronic signatures (EU Digital signature directive)
Everybody using computers in FDA regulated environment?
Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare, and Nicholas Buhay, Part 11 Compliance