2019 - Why & How do we Fail an FDA Inspection

Overview
Trend of inspections is changing globally. While earlier the inspections were focussed on evaluating the procedures in line with the established International standards, but now the focus is on an Investigative approach.
Industry is now moving towards paperless operations, controlled through software. So as to ensure minimal data integrity problems. But it is the MAN, who performs an activity and records the data. A small gap in the operations and recording, leads to Data integrity problems.
If we review a post audit observation report of any facility, it is the least possibility that certain standard procedures were INCORRECT, but the observations relates to the fact that the established procedures were not followed. If everything was possible to be controlled through software/electronic data management, none of the facility audits would fail. Then what is the Factor responsible, it is the MAN, who intentionally or unintentionally commits the errors leading to failure.
Therefore we need to identify the areas, related to human error, which are more prone resulting in the gaps leading to non-compliances.
Why should you Attend
The webinar covers the details on the areas which should be focused in order to ensure 'All time compliance' in the facility.
Areas Covered in the Session
Comprehending the most Common Areas Ignored & its Repercussions
Maximizing the level of Compliance by Minimizing the Human Errors
Who Will Benefit
QA
QC
Production
Projects & Engineering
Maintenance
Speaker Profile
Mr. Vikram Kulshreshta is a Senior Management Professional with experience of more than 30 years with strong Quality Assurance & Regulatory Affairs background, with a good track record in the Organizations worked for. He is an expert in “Designing & implementing the Quality Systems”, Qualifications & Validations, Trouble-shooting & CAPA implementation and Regulatory Affairs.