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. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.
Why Should You Attend:
Effective and compliant computer system validation is critical to any FDA-regulated organization. FDA has set forth very specific requirements for meeting compliance, and a very prescriptive set of enforcement actions to protect patient and/or consumer safety. This course will enable you to best anticipate and prepare for FDA scrutiny, understand your role during inspections and audits, and gain insight to the level of enforcement associated with various findings, consent decrees and warning letters. Examples from industry will be used as case studies to illustrate these.
It is vital for regulated companies to maintain a pulse on the regulatory environment in order to fortify system validation efforts, as necessary, to meet FDA expectations. It is the best practice to have a robust computer system validation, continue executing against it consistently, and documenting it thoroughly. By maintaining a strong and consistent computer system validation program, companies can further build trust with FDA and the consumers who rely on such oversight for protection.
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.
Areas Covered in the Webinar:
- Learn about Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
- Learn about the importance of doing a risk assessment of all FDA-regulated systems
- Learn about the importance of categorizing your FDA-regulated software according to GAMP 5 guidelines
- Understand “GxP” Systems
- Understand 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
- Learn how Data Archival plays a key role in ensuring security, integrity and compliance
- Learn 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
- Understand the latest guidance from FDA on data integrity
Who Will Benefit:
This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance.
Examples of who will benefit from this webinar include:
- Information Technology Analysts
- Information Technology Developers and Testers
- QC/QA Managers and Analysts
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Specialists and Managers
- Supply Chain Specialists and Managers
- Regulatory Affairs Specialists
- Regulatory Submissions Specialists
