This latest series on Computer Systems Validation will explore proven techniques for reducing costs associated with implementing, using, & maintaining computer systems in regulated environments. The FDA performs GxP & Part 11 inspections, with an updated Annex 11 regulation, & companies must update their systems and processes to maintain compliance.
There is no doubt that data integrity is the current and future inspection focus of all regulatory health care agencies. More than 60% inspection reports such as 483’s and Warning Letters quote data integrity as deviations from GxP regulations. Only way to control and avoid warning letters is by receiving effective Training. Mr. Kalpesh Vaghela’s extensive years of experience in Data Integrity can help your team to better understand & could help reduce your vulnerability of getting 483’s and warning letters.
Why You Should Attend:
This virtual workshop provides the regulatory background and guides attendees through the complete record lifecycle from data evaluation, reporting, archiving and retrieval. It also helps to fully understand not only the text but also the meaning of related regulations such as FDA’s Part 11 and the Annex 11.
Our instructor will use examples and real life case studies to better illustrate the application of the techniques for any validation project. Using recent warning letters as examples, this seminar will demonstrate how current Part 11 requirements will be met. With effective implementation of learning from this course, you can avoid warning letters, reduce costs, improve quality, increase compliance with less documentation. The course not only ensures a full understanding of the regulations and guidelines for raw data and other records but also develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations.
A must attend seminar for professionals in Pharmaceuticals, QC Laboratories, Manufacturers of drug substances (APIs), Oral Solid Dosage Form, Contract Laboratories, Clinical research Organizations, Contract Research Organisations, Contract Manufacturing Organisations and Biopharma companies.