Overview:
The principles of good documentation practices are applicable to both paper and electronic data or records filled manually or generated electronically in a GxP environment. The webinar will cover requirements of maintaining complete, accurate, truthful and verifiable data in all cGXP documents that are needed to be maintained as per regulatory requirements and various Governmental regulations, laws, rules and statutes/acts. The importance of data generation, maintaining data lifecycle, data governance and data reliability throughout the lifecycle of the document will be covered.
Why you should Attend:
As per Good Manufacturing Practice in regulated industry or in any industry, documentation control is interpreted as "If it is not written down, then it did not happen". The document provides information on when, where, who, why and how to complete the task. The document provides evidence proving that the tasks have been completed as they should be.
Areas Covered in the Session:
Who Will Benefit:
Dr. Chaitanya Baliga has over 20 years of experience in quality management systems, regulatory compliance, and supplier management in industries, such as consumer products, medical device, pharmaceuticals, automotive, and toys. One of Chaitanya’s responsibilities is ensuring quality and compliance activities pertaining to manufacturing of regulated products (drugs, natural health products, cosmetics, and medical devices).