The latest approach for complying with 21 CFR Part 11
Instructor:
Sam Mistretta
Product ID: 700664
- Duration: 60 Min
Why Should you Attend:
Organizations must first develop an interpretation of 21 CFR Part 11 compliance particular to that organizations IT infrastructure, operations, and procedures. From this a targeted re-useable training and validation model can be established. Part 11 can be thought of as a common thread that is weaved throughout the organization touching all aspects of GMP compliance where hardware and software applications are utilized. Configuration Management of complex laboratory and manufacturing systems plays a key role in identifying risk within a given process. Giving end-users the proper tools and training ensures effective monitoring and change management can occur.
Areas Covered in the seminar:
- Defining the scope of 21 CFR Part 11.
- Interpreting the rule.
- Applying the rule.
- Road to compliance.
- Validation considerations.
- Training for part 11.
- Monitoring for compliance.
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that need to comply with 21 CFR Part 11 including companies in the Pharmaceutical, Biopharmaceutical, and Medical Device field. The employees who will benefit include:
- Regulatory Affairs
- Quality Assurance
- Information Technology
- Laboratory Managers
- Validation Manager
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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