Webinar: Regulatory & Quality Expectations After Health Authority Approval
Overview
The pharmaceutical life cycle is a complex structure of interconnected processes. A seemingly minor change can have a significant impact on validated processes and regulatory filings.
Learn from industry experts how to bridge the gap between the operational challenges and regulatory expectations by handling changes throughout the drug product life cycle.
When
Wednesday, 17 August 2022
15:00h – 16.00h (IST)
11.30h – 12.30h (CET)
05.30h – 06.30h (EDT)
Free Registration: Click to reserve your seat!
After registering, you will receive a confirmation email containing information about joining the webinar.
Key Takeaways
- Streamlining Change Control Management
- Do & Don’ts to take control of Product Life Cycle
- Identifying & Overcoming Data gaps across the Product Life Cycle
- Reducing risks, errors, implementation time, and improving profitability.
- Maintaining an effective Quality Management System and Product Quality System
- QMS Regulation and Guidelines – ICH Q8, Q9, Q10, Q11 and Q14
- Engaging with Industry peers and sharing Common Learnings
Who Should benefit?
From C-level executives through Quality VPs, Directors, from managers to the knowledgeable professionals in the lab;
A shared vision with a milestone on the horizon, visible to all stakeholders, is the recipe for success.
Session Learnings
In this webinar, the attendees learn how to take a holistic view across the value chain and the transition from Regulatory Challenges to Product Life Cycle Control.
Featured Speaker
Joe Albanese, Ph.D.
Managing Director of Albanese Consulting, LLC
Joe recently retired from Janssen Pharmaceuticals (part of Johnson and Johnson) with 29+ years of experience in the pharma industry. He held positions in R&D, Supply Chain, and Quality such as Associate Director Product Lifecycle Management and Director Global Quality Systems. His experience has spanned both Small Molecule & Biotherapeutics deve opment, manufacturing,and supply for Janssen.
Speaker
K Lakshmi
Network of Excellence Lead, Global Value Web
Pharma professional certified Six Sigma Black Belt Professional, and has over 14 years of work experience in various streams of the pharmaceutical industry; including, but not limited to, Sales and marketing, patents, Literature Management, and in Drug Product Development.She’s been with GVW for over 10 years and currently leads a Drug Product Development Team.
Moderator
Louis Hendriks
Founder and CEO of Global Value Web
Through over 30 years of experience in enabling global value chains/networks, Louis brings to GVW, a deep understanding of partnering in global networks, and delivering competitive value to clients. Prior to starting Global Value Web, Louis has driven many value chain improvements and integrations for various global companies.
