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Labcompliance On-line Audio Seminar

On-line Audio Seminar 149

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here)

Using the SAFE Standard for Digital Signatures

For Legally Enforceable IP Protection, Electronic Transactions and FDA Submissions

Presented by George Kuniholm, Regional Director, CSSC Inc


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SAFE stands for "Signatures and Authentication for Everyone". It is a global identity management coalition that resulted from a need to provide a consistent and industry-wide method for managing and utilizing digital signatures. It is sponsored by the Pharmaceutical Research and Manufacturers of America (PhRMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) trade organizations with funding Bio-Pharmaceutical organizations. It is a framework that gives companies the ability to sign regulatory and commercial transactions in a legally enforceable way. It also will help to protect company's IP through digitally signed and legally defensible electronic research records. Because of these advantages and benefits there is a high interest in this project within the (Bio-Pharmaceutical industry. However, there are also many questions.

Key Questions related to SAFE are:

  • What exactly is SAFE?
  • Who can become a member?
  • What is the scope and main purpose?
  • What are the benefits?
  • Which companies are participating?
  • Are digital signatures legally binding as notarized wet signatures?
  • What is the difference between electronic and digital signatures
  • How does the signature process work?
  • How do I identify myself when I sign a document?
  • Who certifies the authenticity of a signer?
  • Can a company use an internal certification agency?
  • Do we need special software?
  • Can this concept be used for open systems, e.g., the public internet?
  • Is this accepted by FDA and international agencies?
  • How is this implemented in companies?

How does the audio seminar help:

Answers will be presented by George Kuniholm in a new interactive audio seminar. During the seminar, the speaker will give an overview and give practical recommendations. After the seminar, an extensive list of reference material like primers, SOPs, templates and a checklist will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • Current Environment sifting to Electronic commerce
  • Trends in Biopharmaceutical / Medical Device Development
  • Challenges posed by Electronic Commerce in Healthcare
  • Creating Trust through a Single Standard for Electronic Credentials
  • History of SAFE
  • SAFE’s Legal Framework
  • SAFE Organizational Architecture
  • Technical Specifications for SAFE
  • Implementation Roadmap:
    - Establishing a Business Case
    - SAFE Implementation Checklist
    - Establishing Policies, Procedures and Guidelines
    - Opportunities for Efficiencies
    - Timeline
  • Current Membership
  • Integration with Industry Organizations and Regulatory Agencies
  • Current Initiatives with SAFE

And for easy and instant implementation:
download 10+ documents from special seminar website

  • SOPs:
    - Using Internet and Intranet in Regulated Environments
    - Testing File Integrity of E-Mail Attachments
    - Handling Security Patches
  • Templates/Checklists/Examples
    - SAFE Implementation
  • Reference paper:
    Using the Internet in Regulated Environments
  • FDA and other regulations and guidelines
    - 21 CFR Part 11: Electronic Records&Signatures
    - FDA Guidance: 21 CFR Part 11 Electronic Records&Signatures
    - FDA Guidance: Electronic Means to Distribute Certain Product Info
    - FDA Guidance: Providing Regulatory Submissions to the Center
    for Biologics Evaluation and Research (CBER) in Electronic Format
    - FDA Guidance: Providing Regulatory Submissions in
    Electronic Format - NDAs
    - FDA Guidance: Preparing Data for Electronic Submissions in ANDAs
    - FDA Guidance: Providing Regulatory Submissions in Electronic Format –
    General Considerations-
    - Electronic Signatures in National and Global Commerce Act
    - European Directive - Community Framework for Electronic Signatures
  • And more....

Who should attend?

  • Corporate management representatives
  • QA managers and personnel
  • Manager of operations
  • IT managers and staff
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Training departments
  • Documentation department
  • Consultants

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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About Audio Seminars

Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions over the phone
  5. Ask questions through web forms

Attendees can discuss and ask questions over the phone, fax or e-mail.

The transcript and questions and answers have been be posted at the seminar website. This includes questions that came through e-mail and life during the seminar.

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.