This webinar will provide valuable assistance to all regulated companies that require regulatory compliant systems be maintained included are companies in the Pharmaceutical, Biopharmaceutical, and Medical Device fields.
Identifying and qualifying all key components of the network infrastructure including server routers and gateway appliances accomplish this. The network is stress tested to demonstrate available bandwidth for various segments of the local area network. In addition effective change management and procedural controls provide the means for documenting and monitoring a dynamic computing environment.
Areas Covered in the seminar:
- Infrastructure component inventory.
- Design Qualification model.
- Installation Qualification model.
- Operational Qualification module.
- Protocol development and execution.
- Remediation.
- Maintaining compliance.
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that require regulatory compliant systems be maintained included are companies in the Pharmaceutical, Biopharmaceutical, and Medical Device fields. The employees who will benefit include:
- Regulatory Affairs
- Quality Assurance
- Information Technology
- Laboratory Managers
- 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.
