Until May 31, Early Bird Price: 14,000
Sale Date Ended
June 01 to July 11, Regular Price: 16,000
Sale Date Ended
Introduction to the FDA
21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures
The Five Keys to COTS Computer System Validation
Ten-Step Process for COTS Risk-Based Computer System Validation
How to Write Requirements and Specifications
How to Conduct a Hazard Analysis/Risk Assessment-Exercise
System Change Control
Purchasing COTS Software
Cost Reduction Without Increasing Regulatory or Business Risk
FDA Compliance Specialist,
Computer System Validation's principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 260 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.
Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory inspections: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.
Projects involve: medical devices, blood bank, clinical trial, corrective action, document control, electronic data capture, Excel spreadsheets, laboratory instruments, laboratory information management (LIMS), manufacturing, enterprise resource planning, toxicology systems, and VMWare.
David Nettleton is also the co-author of:
Location: Mumbai, India Date: July 13th & 14th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: The LaLiT Mumbai
Address: Sahar Airport Road, Andheri East, Mumbai - 400059
Register now and save ₹ 2000. (Early Bird)
Price: ₹ 14,000 (Seminar for one Delegate)
Until May 31, Early Bird Price: 14,000 from June 01 to July 11, Regular Price: 16,000