This Two-Day online training is specifically designed to understand the significance of robust Pharmaceutical Quality Management Systems in the industry [with an emphasis on Data Integrity, Governance, Compliance & Controls] in the wake of Repetitive & Serious Data Integrity concerns raised 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 Metrics elements are evident following Inspectional observations by global Agencies & the turbulence in industry ever since the Covid-19 pandemic broke out to meet additional unforeseen challenges. 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.
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.
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