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The Medical Single Audit Program(MDSAP) offers the opportunity to demonstrate compliance with the regulatory requirements of up to five participating countries during a certification process. It has been quite a challenge for all of us at Cellview Imaging to go through the stages of certification audits. However, with lots of efforts from RA/QA team and…

In 2018, I had an opportunity to work with a research company- focusing on studies on control of environmental microbiology and pathogens. As a QA consultant, I worked with an amazing team to implement the requirements for Quality Assurance Unit as per OECD guidelines. The full inspections for both facilities and study audits were conducted…

In 2009, I worked on an exciting project to transfer the manufacturing facility and product lines from Europe to Canada. During the transfer plan, I visited the facility in France as well as I performed the audits of critical laboratory suppliers in France. The plan was moving forward until the entire QMS for injectable product…