21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s.

Armen Khachadourian

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This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

Why Should You Attend:

This webinar will describe exactly what is required for compliance with Part 11 and the updated European equivalent Annex 11. It will take the concepts described in the regulations and expand them into specifics for all three primary compliance areas: SOPs, product features, and validation. Attendees will learn what is required for IT, SaaS, and cloud hosting. All required IT SOPs will be described. Product features based on the current industry standards will be explained in detail. The 10-step risk-based validation approach is outlined so that the specific documents for a validation project are understood.

Areas Covered in the Webinar:

  • Which data and systems are subject to Part 11 and Annex 11
  • What the regulations mean, not just what they say
  • Avoid 483s and Warning Letters
  • Explore the three primary areas of compliance: SOPs, software product features, and validation documentation
  • Learn the requirements for IT, SaaS, and cloud hosting
  • Ensure data integrity, security, and protect intellectual property
  • Understand the current computer system industry standards for security, data transfer, and audit trails
  • Electronic signatures, digital pens, and biometric signatures
  • SOPs required for the IT infrastructure
  • Product features to look for when purchasing COTS software
  • Reduce validation resources by using easy to understand fill-in-the-blank validation documents

Who Will Benefit:

  • Computer system users
  • IT personnel
  • QA personnel
  • Managers
  • Executives
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Armen Khachadourian, President and Founder, Digital Payments LLC

Armen Khachadourian is the founder and president of Digital Payments Inc, a consulting firm providing advisory services in the areas of merchant processing, ISO/MSP formation, merchant portfolio and acquiring acquisitions, prepaid and alternative payment products including decoupled debit. As a trusted partner with vision to understand his client’s future business he has helped design and evaluate several new products and services in today's changing marketplace, such as: development of connectivity products for payment cards; digitization of electronic benefit transfer and means tested programs; merchant card acceptance and capital funding solutions; cross border money transfer and bill payment services; BSA/AML best practices and guidelines; and, alternative payment products and services, prepaid and gift.

Mr. Khachadourian has also served in executive positions at several top ten financial institutions and helped them maximize growth and revenues in today’s challenging electronic payments marketplace. As a vice president of JPMorgan Chase’s Prepaid Product in Treasury Services, he was responsible for designing and launching prepaid cards in the EU market. As a senior vice president at Visa USA, he expanded card acceptance to new markets such as supermarkets, recurring payments, quick service restaurants and federal government agencies. His expertise in card products extends to issuance of credit, debit, prepaid and commercial cards.

Mr. Khachadourian earned a bachelor’s degree in mathematics and a master’s degree in computer science from the San Jose State University in California. He authored the “Basics of Data Communications” textbook and lectured at College of San Mateo, CA. He was awarded an honorary teaching credential by the State of California. Mr. Khachadourian is a member of the United States National Masters team; he has represented United States at four world championships. He is an accomplished marathon runner and tri-athlete, having completed in seven Ironman competitions.


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