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Workshop Overview

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.

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One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations, Root Cause analysis, CAPA & risk assessment. The FDA uses the investigation reports and investigation trends to identify potential quality problems and action plan taken in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, release of sub-standard product, or product recall. Furthermore, costly and time-consuming system remediation may be required.

Having a procedure on investigations, Root Cause analysis, CAPA & risk assessment is not enough. It is the strategy, content, extent of efforts made and final conclusions that truly count.

This seminar will help attendees understand the fundamental steps, practical approach towards investigations, Root Cause analysis, CAPA and proactive approach as well as reactive approach of risk assessment.

Key focus will be put on practical examples, implementation & compliance practices with respect to current guideline requirements, FDA citations and learning from observations.

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.

This course has been updated to include the update on 21 CFR Part 11 and also electronic version of CFR part 11. Further we are ensuring to make you understand about the new FDA expectations for computer software assurance(CSA).

This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements.
Regulatory guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.
The course will provide principles and an overview of the overall computer systems compliance.

This 2 -days event will provide a basic, but a comprehensive overview of Overall Global Pharmaceutical Regulatory-Affairs in a relaxed and interactive environment, yet complete focus on Quality, Safety, Efficacy and Market Driven Targets’ . The aim shall also be to touch basis Laisioning with various Ministry of Healths (country-specific FDAs)