The webinar will address each audit item and train the participants how to determine the compliance status. We will use common examples of non-compliance observations from actual audits and suggest remediation plans that are compliant, efficient and economical.
We are required to manage the quality and assure the validation state of computer systems used in support of regulated pharmaceutical processes (cGMP, GLP, GCP, QSR). This presentation will go over the 'how-to' in a way that is simple and intuitive. We will include templates for auditing computer systems used in support of regulated GXP processes.
We are required to manage the quality and assure the validation state of computer systems used in support of regulated pharmaceutical processes (cGMP, GLP, GCP, QSR). This presentation will go over the 'how-to' in a way that is simple and intuitive. We will include templates for auditing computer systems used in support of regulated GXP processes.
Areas Covered in the seminar:
- 21CFR Part 11 Requirements.
- Regulatory Inspections of Computer Systems.
- Risk-Based Inspection and Validation.
- System Inventory Assessment - Preliminary Risk Assessment.
- Compliance Assessment - Compliance Risk Analysis, Gap Analysis and Corrective Actions.
- Remediation Plans and Schedules.
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that need to manage the quality and validation state of their computer systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. Contract facilities providing clinical, laboratory and data systems will also benefit.- End-users responsible for applications and systems
- QA managers and personnel
- Information Technology managers and personnel
- Senior Quality, Regulatory and Operations Management
- Regulatory Affairs staff
- Quality system auditors
Course Provider
Richard Poser(PhD),
