Harry Huss
Instructor Harry Huss
Product Id 600910
Duration 90 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Current Concepts & Challenges in Cloud Compliance

Overview:

The evolution of computerized technologies has been both amazing and challenging. Each new wave of technological evolution has been accompanied by a series of compliance challenges, and subsequent strategies to comply with applicable regulatory requirements. Cloud computing is a current example of this evolution.

This presentation will provide a discussion of Cloud concepts, terminology, definitions, architecture, and services; review the contradictions and challenges of using a cloud environment to support regulated activities; discuss assessments of cloud hosting facilities; and stress the importance of a detailed Service Level Agreement (SLA).

Why should you attend: Cloud computing has become perhaps the hottest compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantees that management will expect that compliance strategies will be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help the attendee better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.

Areas Covered in the Session:

  • Understanding the Cloud Definition
  • The Basics - Architecture & Services
  • Contradictions and Challenges
  • Cloud Provider Assessments
  • Compliance - Past, Present, Future
  • The Service Agreement
  • Closed vs. Open Systems
  • Perspective / Compliance Notes / Conclusions
  • Questions & Discussion

Who Will Benefit:
  • Project/Strategic Management
  • Quality Assurance staff
  • IT staff
  • Operations staff

Speaker Profile
Harry Huss has over 30 years of experience in the pharmaceutical/medical industry. He 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. Harry has a M.S. degree in Clinical Microbiology from Thomas Jefferson University, and B.S. degrees in Biology and Medical Technology from Millersville University and Bryn Mawr respectively.

He has provided numerous computer validation and Part 11 presentations at professional meetings, provided computer validation training for the FDA, authored a Master Validation Plan for the FDA National Center for Toxicological Research (NCTR), and published a variety of scientific and regulatory compliance articles. Harry is a member of the Drug Information Association Validation SIAC Core Committee and a member of the Society for Quality Assurance Computer Validation Initiatives Committee (CVIC).

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