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