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Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel

  December 23, 2010  

GlobalCompliancePanel, Online Training Webinar

Overview: Although Part 11 has been around for over a decade, lack of visibility can sometimes render compliance with this regulation an afterthought.

Due to serious inefficiencies and non-conformance issues associated with trying to address Part 11 late in the system lifecycle, it is important to give the technical requirements due consideration early in the process. A good understanding of these technical requirements is paramount to avoiding the syndrome of "testing into compliance" later on. Often, the compliance status of a system can be impacted by varying interpretations of the regulation if not properly addressed. This session will provide a focus on understanding the key considerations for the technical requirements of Part 11, to ensure system are compliant from a Part 11 technical perspective and, when coupled with sufficient procedural controls, will result in an overall Part 11 compliant deployment.

Why should you attend: With the announcement in 2010 of a new Part 11 Inspection initiative, life science organizations can expect to see a higher level of scrutiny of the compliance of computerized systems utilized for regulated activities. To avoid any regulatory observations on your automated systems, it is important to ensure that compliance is built into those system from inception. This requires a good understanding of the technical requirements of 21 CFR Part and how to implement them.

Areas Covered in the Session:
  • Leveraging a Part 11 Interpretation document
  • The Importance of Part 11 in Requirements and Specifications documents
  • The Role of Risk Assessment in Part 11 Compliance
  • Technical Controls for Electronic Records
  • The Many Flavors of Audit Trails
  • Open vs. Closed Systems
  • Technical Controls for Electronic Signatures
  • Handwritten vs. Electronic vs. Digital Signatures
  • ID/Password Requirements - Records vs. Signatures
  • Validation as Proof of Compliance
Who Will Benefit:
  • IT Managers and Personnel
  • QA Managers and Personnel
  • Validation Managers and Personnel
  • System Vendors
  • Developers
  • Consultants
Organized by: GlobalCompliancePanel
Invited Speakers:
Robert J. Finamore serves as the Director of Professional Services for QPharma, Inc., a regulatory compliance consulting firm based in Morristown, NJ. He has been a leader at QPharma over the past 12 years in the management and execution of over 100 regulatory compliance projects, and is a recognized expert in computer system validation and 21 CFR Part 11 compliance. Examples of his Part 11 experience include: consulting with system vendors to design compliance controls into their applications, development and execution of site-wide Part 11 assessment and remediation programs, and designing and a carrying out a global Part 11 policy development and training program. He currently oversees the Professional Services group within QPharma, which executes regulatory compliance projects in the fields of validation, quality systems, medical device consulting, training, and auditing for life science customers.
Deadline for Abstracts: 2011-02-16
Wednesday, February 16, 2011  
10:00 AM PST | 01:00 PM EST
Live live online training only for one participant
Price: $245.00
Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care)
Price: $995.00

Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Price: $295.00
E-mail: webinars@globalcompliancepanel.com
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