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.
At the end of this workshop the cross functional team members will be more conversant with the most current global Regulations for Remote Auditing .
They will be able to ensure –
They will also learn effective methods for remote working with effective and well-practiced project management, processes, and technology capabilities. Once the gaps are identified, the CFT will be able to bridge them and align themselves with the current global Regulatory & GMP Expectations wrt additional aspects now mandated by the Covid-19 Disaster. By channelizing the Management for effective monitoring to control systems and processes ,organizations would be able to manage the risks involved via timely decisions by efficient Transition phase Management to ensure faster approvals of Marketing Authorization applications thereby meeting the business aspirations of the Company despite the Pandemic challenges .
IIT Kanpur Scholar, Synthetic Organic Chemistry
Trainer for QBD, GMP and Regulatory Affairs
A Senior Pharmaceutical Scientist with 28 years of Industry Experience in various leadership positions in multi-disciplinary departments.
A Freelance Advisor imparting trainings, workshops, Pharmaceutical guidance ; conducting GMP inspections and audits of plants for both API & Formulations, Technical Content writing for Specialised Technical n Soft skill aspects in Academic Institutions & Industry.
Ranbaxy Research Laboratories,Morepen Labs, Torrent Pharmaceuticals,Nicholas Piramal Ltd, Unimark Remedies,Glenmark Pharma, Indswift Labs, Naari Pharma
Chemical Research Division [RnD], Drug Regulatory Affairs [RnD & Plant], Corporate Quality Assurance [Multiple locations], Corporate Regulatory Affairs, RA &QA [RnD], Manufacturing plant Compliance.
Mohamed Anvar Deen
CSV and IT GxP compliance Lead at SUN PHARMA
Head Quality Assurance – External manufacturing , Sanofi India Ltd.
Member, of several professional organizations including IPA , IPA-APA, MPA. Presently Vice President of IPA Baroda branch.
Qualification : Bachelor of . Pharmacy in 1988 from M. S. University, Vadodara. ISO 9008 certified auditor, IRCA certified QMS provisional auditor & Qualified auditor of Sanofi.
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