ComplianceOnline

Change Management for Regulated IT Processes

Instructor: Sam Mistretta
Product ID: 700761
  • Duration: 60 Min

recorded version

$199.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar will provide valuable assistance to all regulated companies Information Technology practices including companies in the Pharmaceutical, Biopharmaceutical, and Medical Device fields.

Description

The Current GMPs and global standards established by the FDA and numerous global regulating authorities require that Information Technology operations under their auspices demonstrate sound Change Control practices as a fundamental tenant of Configuration Management in general.

Why Should You Attend:

It is recognized that rapidly advancing electronic data handling systems require close monitoring and inspection as being the fundamental means for an organization to maintain all facets of compliance including laboratory data handling systems, manufacturing, enterprise resource planning, corrective action, training, electronic regulatory submissions, etc.

Areas Covered in the Webinar:

  • Defining the scope of Change Management
  • Establishing a compliance model
  • Principles of Configuration Management
  • Laboratory Control Systems
  • Manufacturing Systems
  • Change Control Processes
  • Maintaining compliance

Who will benefit:

This webinar will provide valuable assistance to all regulated companies Information Technology practices including companies in the Pharmaceutical, Biopharmaceutical, and Medical Device fields. The employees who will benefit include:

  • eCTD Submission Specialist
  • QA CAPA System Administrators
  • IT Director
  • QC Laboratory Compliance Specialists
  • Validation Manager

Instructor Profile:

Sam Mistretta, is the founder and CEO of CyberVal Pharma, Inc. a consulting firm that specializes in technical, regulatory, and scientific services for the pharmaceutical, biopharmaceutical, and medical device verticals. Sam is a Microsoft Certified Systems Engineer degreed in Interdisciplinary Natural Sciences with bench experience in the microbiology and chemistry laboratories for QC & R&D GMP environments. One central focus has remained complying with 21CFR Part 11 and all the challenges this presents.

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ComplianceOnline Medical Device Summit 2017
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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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