FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed.
This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data integrity. The life cycle approach takes all aspects of validation into account throughout the life of the system and the data that it houses. The data is a key asset for any FDA-regulated company and must be protected through its entire retention period.
This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.
- To become aware of areas of FDA focus during inspection and learn how to prepare to become inspection-ready.
- Learn about the potential areas of risk during FDA inspections of computer systems and how to avoid these pitfalls.
- In their professional capacity, they will be much more knowledgeable about FDA audit and inspection, and what to do to prepare for these.
Areas Covered in the Session:
- Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
- Importance of risk assessment of all FDA-regulated systems
- Categorizing the FDA-regulated software according to GAMP 5 guidelines
- “GxP” Systems
- 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
- How Data Archival plays a key role in ensuring security, integrity and compliance
- How to develop a solid Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes
- Learn about recent FDA findings for companies in regulated industries, specifically related to computer systems, validation, 21 CFR Part 11 and data integrity
- Latest guidance from FDA on data integrity
- Recent trends in technology that need to be addressed in the CSV approach
- Industry best practices for becoming inspection ready
- Live Q&A Session
This is an all-inclusive webinar benefiting all individuals within the Pharmaceutical, Medical device, Biological, Tobacco, Food and Cosmetic manufacturing organizations but particularly those in positions of management and supervision.
- Information Technology Analysts
- QC/QA Managers
- QC/QA Analysts
- Clinical Data Managers
- Clinical Data Scientists
- Analytical Chemists
- Compliance Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Managers
- Manufacturing Supervisors
- Supply Chain Specialists
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
- Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
- Auditors engaged in the internal inspection of labeling records and practices
About the Presenter:
Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. Carolyn has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. She is currently an independent consultant, advising companies on FDA compliance, computer system validation and large-scale IT system implementation projects.
You will receive an email with login information and handouts (presentation slides) 1 day before the live webcast that you can print and share to all participants at your location.
Operating System: Windows any version preferably above Windows Vista & Mac any version above OS X 10.6
Internet Speed: Preferably above 1 MBPS
Headset: Any decent headset and microphone which can be used to talk and hear clearly
Can’t Listen Live?
No problem. You can get access to On-Demand webinar. Use it as a training tool at your convenience.
For more information you can reach out to below contact:
Toll-Free No: 1-302-444-0162
Email: [email protected]
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