The event aimed to educate the pharma professionals about the do’s and dont’s during the auditing process
Sachin Jagdale – Mumbai
Managing audits in the pharma industry has always been a complex issue for the pharma operators. To educate the pharma professionals about the do’s and dont’s during the auditing process, UBM recently organised ‘Unannounced audits’ workshop 2016 in Mumbai. Representatives from various reputed pharma companies attended the workshop. Throughout the workshop, the focus was on managing audits in challenging environment in order to meet regulatory expectations.
On day one, Bhavan Mehta, Independent Consultant, FDA expert gave the course introduction and objectives. By giving a few examples of Indian pharma companies who had received warning letters from the regulatory authorities, Mehta spoke on inspection management and good documentation practices. Mehta’s lecture on data integrity and applicable guidance was well received by the audience with many attendees raising questions and Mehta solving them to their satisfaction.
Mohan Ponnudurai, Program Director, Sparta Systems and Anand Iyer, Account Director, UL India were also the speakers on day one. Ponnudurai taught the audience how to manage internal and external audits to reduce risk and ensure compliance. Iyer used few attendees as objects while explaining how to face the audits. He gave a few examples of how employees at the plant get anxious while facing the auditors and how to face the auditors without making spoken or behavioural mistakes.
Contamination control is one of the most worrying issues for the drug manufacturers. Avinash Vhanakaware, Segment Marketing Manager, Kimberly Clark Hygiene Products, briefed the audience on the ways to control contamination. All the sessions during the day were very interactive and the participants got to know many new things about the auditing process.