Auditing Systems for 21 CFR Part 11 Compliance: Preparing Yourself for Inspection

Why Should You Attend:

Can you show me how you manage your computer systems in compliance with 21CFR Part 11?

This presentation will describe a process which has prepared several companies to answer this question from FDA inspectors accurately, completely and to the great satisfaction of the inspectors. We will show how to inventory the site, assess the compliance risk of existing systems, implement new systems, remediate any non-compliance found, prepare SOPs and quality policies, collate the required documentation and train the staff.

Attendees will learn how to prepare and present a concise and comprehensive presentation to regulatory inspectors. Preparation and knowing in advance the expectations and required deliverables for a successful inspection is critical to your pharmaceutical, medical device, biotechnology or software company. Case studies will be presented showing the outcomes for three inspections at companies following this methodology.

Areas Covered in the seminar:

• 21CFR Part 11 Requirements.
• Regulatory Inspections of Computer Systems.
• Required Policies and Procedures.
• Training.
• Performing a Comprehensive Inventory: Team Effort.
• System Inventory Assessment - Preliminary Risk Assessment.
• Compliance Assessment - Compliance Risk Analysis, Gap Analysis and Corrective Actions.
• Remediation Plans and Schedules.
• Presenting to the Inspector.
• Case Studies : Federal and State Regulatory Inspections.

Who will benefit:

This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities, 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

Instructor Profile:
Dr. Rich Poser, is President of First Quality Inc., a quality consulting firm focused on Quality Systems, Training and Validation. Their clients include biotechnology, pharmaceutical and medical device manufacturers, as well as the vendors such as contract laboratories, instrument manufacturers, contract manufacturing sites and software developers that support these highly regulated industries.

Dr. Poser was Director of Analytical Sciences and later Director of Information Systems at the Fisons Pharmaceuticals site in Rochester, NY. Following work in product development, laboratory automation, and validation and quality systems for the Mylan Pharmaceutical Company, Rich joined Dura Pharmaceuticals in San Diego as Analytical Laboratory Director and Director of R&D Quality Assurance. After the acquisition of Dura by Élan, Rich was appointed Director of Quality Laboratory Operations and led their 21CFR Part 11 training and audit team.

Now in private practice as a quality consultant, he also lectures at UCSD Extension in validation, cGMP Regulations and analytical methods validation, and has presented or chaired public seminars and symposia.

Topic Background:

Life sciences companies should regularly audit and assess computer systems for 21CFR Part 11 compliance, both their internal systems used in support of regulated GxP activities as well as systems used by their contract vendors for manufacturing, laboratory testing, drug safety and clinical studies.   This is done routinely as self-assessment and inventory of existing systems, during the implementation of new systems, as during vendor qualification and periodic audits.

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