FDA is increasing emphasis on scrutiny of computer systems validation and adherence of 21 CFR part 11 compliance to companies under FDA regulatory jurisdiction. A third of FDA”s recent warning letters have been with respect to improper or ineffective validation practices. Increasing use of automated manufacturing and quality system is forcing exposure of computer systems. Validated computerized systems are integral for producing accurate, reliable and consistent data. For many small to mid-sized organizations, meeting the regulatory requirements is a daunting task and Part 11 compliance is a major focus for audits.
This seminar discussed the basics of 21 CFR Part 11 requirements and practical techniques for evaluation of the current compliance status of a given organization. It also covered other areas such as validation plans, user requirements, test plans, test reports, change controls, standard operating procedures, data backup and business continuity. Case studies are used to highlight common issues and potential solutions. We will ensure your readiness for Part 11 compliance to confidently face the next FDA audit.
Held on 28th Jan 2015 | Time: 2 PM EST | Duration: 45 Min
- Defining the scope of 21 CFR Part 11
- Compliance Assessment
- Validation of Computer Systems – Validation Plans, Checklists and Test Reports
- Implementation and Documentation Recommendations
- Achieving Successful Compliance
- Preparing for 21 CFR Part 11 Inspections
Karthikeyan Balasubramanian, AVP – QA & Validation Services, comes with 15 years of experience in Software Testing focusing mainly on QA Validation managing services, quality & delivery.
He manages solutions & delivery of validation engagements for clients requiring FDA regulatory implementations. Prior to his stint at Indium, he spent his entire career in the USA as a testing service/management consultant for companies like Schering Plough, Yamaha Music & AIG.