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: +1-650-963-2556

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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