3 Vital Courses on FDA 21 CFR Part-11: Concept, Compliance and Auditing

Title 21 CFR Part 11 of Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures. Part 11, as it is frequently called, elucidates the parameters under which electronic records and electronic signatures are considered to be authentic and equivalent to paper records. The solution to FDA 21 CFR Part 11 compliance is to utilize the law to your benefit, and not tries to ignore it or evade it.
Instructor: Angela Bazigos, Harry Huss, Herman Wong
Product ID: PACK70001

This training provides an overview of documentation requirements and systems that can be used to meet the 21 CFR part 11 rules and stipulations.


CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations.
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  • Recording links will be valid up to 6 months with unlimited access and reference materials will be mailed to your registered e-mail.
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Webinar Topics:


Who will benefit?

These webinar will be beneficial to the following:

Quality Engineers/Managers, Small Business Owners, Consultants, Project/Strategic Management, Quality Assurance, IT Executives, Operations Executives, Anyone Selecting Computer systems intended for FDA Regulated Environments, Executives evaluating requirements Part 11 compliant systems


Webinars included in the Package:


21 CFR 11 Compliance for Excel Spreadsheets (Duration: 90 Minutes)

Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.

Areas Covered in the Webinar:

  • Requirements for Excel Spreadsheets
  • FDA Part 11 Validation Guidance
  • Compliance Problems with Spreadsheets
  • Design Specifications for 21 CFR 11 compliance
  • Documentation for Part 11
  • Future Trends in 21 CFR 11 compliance for Excel Spreadsheets

Instructor Profile:

Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance.


Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts (90 Minutes)

Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation. Understanding the requirements of Part 11 is critical to compliance with the regulation. Knowledge of regulatory requirements is an exercise in efficiency…both efficiency in project management, and avoidance of non-compliance penalties.

Areas Covered in the Webinar:

  • History and Overview
  • Subpart A: General Provisions
  • Subpart B: Electronic Records
  • Subpart C: Electronic Signatures
  • Scope & Application Guidance

About the Instructor:

Harry Huss is currently Chief Compliance Officer, Touchstone Technologies Silicon Valley; and has held positions as Executive Directive, Brandywine Compliance Consulting; Senior Director Compliance Policy & Program Support Services, Charles River Laboratories; Associate Director of Computer Validation Quality Assurance, Merck & Company; and Regulatory Compliance Manager, SmithKline Beecham.


Auditing for 21 CFR Part 11 (60 Minutes)

21 CFR Part 11 provides the basic framework for computer systems used to generate records and data used for analysis and presentation. Validated computerized systems are integral for producing accurate, reliable and consistent data.

Areas Covered in the Webinar:

  • Part 11 requirements by FDA
  • Validation of computer systems - Validation Plans, Requirements, Specifications, and Test Reports
  • Recommended SOPS
  • Change control
  • Data backup and business continuity
  • Compliance Assessment
  • Planning, preparing and executing audits
  • Common audit findings and tips for a successful audit

About the Instructor:

Herman Wong is a Washington DC-based consultant for computer systems in FDA-regulated industry. He has been in the industry for over 12 years and is the Director of the Information Technology department at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in training of IT personnel in FDA-regulated industry, creating, managing and implementing Part 11 compliant computer systems. Since 2005.

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