Conferences & Workshops

Computer Systems Validation Training by Kalpesh R Vaghela

Computer Systems Validation Training by Kalpesh R Vaghela

PV Chronicle shares one more training Information, Computer Systems Validation Training by Kalpesh R Vaghela, 30 years industry expert. This training is planned in two metro cities i.e Hyderabad and Bangalore.

 

This new 2-day Seminar on Computer Systems Validation will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, with an updated Annex 11 regulation that expands Part 11 requirements, and 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 the field of third party audit of Data Integrity can help your team to better understand & could help reduce your vulnerability of getting 483’s and warning letters, by great amount.

 

This workshop provides the regulatory background and guides attendees through the complete record lifecycle from data entry or acquisition through 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.

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A central element of this course will be an explanation of the GAMP approach to 21 CFR Part 11 compliance, as well as compliance with other international regulations covering electronic records and signatures. The GAMP Guide provides timely and much needed direction on meeting current regulatory expectations for compliant electronic records and signatures.

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The Guide describes how a risk management approach may be used to ensure the compliance of regulated electronic records and signatures, through the application of appropriate controls commensurate wie impact of records and the risks to those records.

The course not only ensures a full understanding of the regulations and guidelines for raw data and other records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations.

For complete details on the Trainings Information : Click Here

Do attend for learning new skills and for good networking. Share in your circles and see you in comments.

 

 

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