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cGMP Compliances, Inspection & Investigation

March 4, 2021 @ 10:00 am - March 5, 2021 @ 5:00 pm

This Two-Day online training is specifically designed to understand the travails of accommodating off-site Pharmaceutical activities including audits & Inspections

With physical workplaces shut down following the Covid-19 disaster , many organizations rushed to stand up virtual workspaces, messaging applications, videoconferencing, and other collaboration tools. This threw new challenges concerning enhanced security and workplace policies to accommodate off-site work. This responsibility now extends beyond the IT Department- It has impacted all CFTs over a much broader workforce wrt conduction of remote activities with strict SOPS regarding Good Cyber Practices & new trainings – off site as well as on site to ensure meeting Targets within deadlines during & beyond the Pandemic.

There is a dire need for robust & revised Pharmaceutical Quality Management Systems in the industry [with an emphasis on Data Integrity, Governance, Compliance & Controls] in the wake of the Pandemic aligned by new Guidelines & Directives spelt out by Regulatory Authorities worldwide .Global Regulatory Requirements and the huge Gaps [in terms of Effective monitoring and controls]with respect to Data Governance , Integrity , Compliance & Quality Control elements are evident following Inspectional observations & the turbulence in industry ever since the Covid-19 pandemic broke out to meet additional unforeseen challenges including assessment & Mitigation of New & unforeseen risks..

Implementation of the adequate systems & Controls via the right written down procedures, in-depth training and managing the transition phase will be discussed with case studies.

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March 4, 2021 @ 10:00 am
March 5, 2021 @ 5:00 pm
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