cGMP Compliances, Inspection & Investigation

(Remote & On-Site Audits)

4th & 5th March 2021

HURRY UP! LIMITED SEATS AVAILABLE…

Workshop Overview

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.

Key Reasons to Attend

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 –

Maintenance of certification -at a time of lockdowns and social distancing.
Greater flexibility in auditing processes
Limited disruption to operations and supply chains

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 .

About the Trainer :

RAJNI JHA
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.

Organizations worked :

Ranbaxy Research Laboratories,Morepen Labs, Torrent Pharmaceuticals,Nicholas Piramal Ltd, Unimark Remedies,Glenmark Pharma, Indswift Labs, Naari Pharma

Division worked:

Chemical Research Division [RnD], Drug Regulatory Affairs [RnD & Plant], Corporate Quality Assurance [Multiple locations], Corporate Regulatory Affairs, RA &QA [RnD], Manufacturing plant Compliance.

About the Speaker :

Mohamed Anvar Deen
CSV and IT GxP compliance Lead at SUN PHARMA

Professional Details (Bio):

Having 16+ years of experience in the Pharmaceutical and biopharmaceutical industry in Quality Control department.
Extensive skills in GMP compliance and IT compliance.
Successfully completed 50+ Computer system validations.
Successfully handled USFDA, WHO, KFDA, COFEPRIS, ISO and Customer inspections.
Successfully handled 100 + deviations and CAPA.

About the Speaker :

Jignasa Oza
Head Quality Assurance – External manufacturing , Sanofi India Ltd.

Professional Details (Bio):

30 + years of experience in Pharma Quality
Have expertise in Managing Contract Manufacturing Sites for Quality Systems including Due diligence, Technology transfer, QMS review.
Successfully handled vendor and CMO audits
Expertise in regulatory audit management.
Qualified auditor, ISO 9008 certified auditor , IRCA certified QMS provisional auditor &
Qualified auditor of Sanofi.
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.

Who Will Attend

Departments

Quality

Manufacturing

Production

Regulatory

Designation

Directors

Senior Vice-Presidents

Vice-Presidents

Heads / HoD’s

Senior General-Managers / General-Managers /

Assistant General-Managers

Managers

Sr. Executives / Executives

current-good-manufacturing-practice

cGMP Compliances, Inspection & Investigation

(Remote & On-Site Audits)

4th & 5th March 2021

HURRY UP! LIMITED SEATS AVAILABLE…

Workshop Overview