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.