Digital Evolution in Impact Analysis for Regulatory Labelling and Artwork Changes
Sponsored by: Perigord Life Science Solutions
- Life Sciences
Date: 9 June
Time: 4PM London/11AM EDT
Learn how you can overcome and manage the challenges of constant change in the end-to-end labelling and artwork process
As the world is digitising, supply chains which are traditionally linear are now transforming into dynamic, interconnected systems. This transformation is exposing the digital disconnects in the labelling and artwork end-to-end process steps. Enhancing a manual based approach to address the digital disconnects is sustainable to a point, but as the quantity and complexity of changes continues to increase, the risk of compliance overburden is likely to negatively impact the supply chain dynamic if an alternative approach is not introduced.
Key challenges to managing the impact of an ever-increasing volume of regulatory labelling and artwork changes include:
• Rising costs of achieving compliance
• Lack of central access to historical and up to date impact knowledge
• Complexity of automatically establishing document and document content relationships for accurate insight and decision making
During this session you will learn:
1. How the move towards dynamic supply chains is increasing and exposing the digital knowledge management disconnects in the non-linear steps of the labelling and artwork process.
2. Why conventional approaches to these challenges don’t solve the problem.
3. What is the scope of Impact Analysis.
4. How to minimise the level of human intervention in completing complex assessments of content changes across related documents and artwork.
5. How to gain an enterprise helicopter view of your labelling and artwork projects.
6. How to simplify the capture and auto transfer of labelling changes from regulatory word PI/QRD to artwork file brief.
7. What a digital impact analysis solution actually looks like.
Benefits of digitising impact analysis:
• Eliminate manual touchpoints involved in identifying artwork components for change and getting labelling updates transferred into artwork briefs.
• Reduce artwork implementation delays and need to destroy stock/re-print.
• Reduce risk and time in aligning disconnected versions of printed vs Health Authority (regulatory regime, body) approved artwork content.
• Reduce of CAPAs related to artwork implementation.
• Reduce in the quantity of projects allowing for easier tracking and management.
• Streamlined Projects – allowing capacity for unplanned/last minute changes to be redirected to facilitate late stage, or just in-time printing.
Reserve your seat to learn how you can overcome and manage the challenges of constant change in the end-to-end labelling and artwork process.
COO, Software Division
Suzanne Ivory joined Perigord in 2005 as the Global Quality Director and in 2018 moved into the role of COO, Global Software Division, for Perigord Data. Suzanne has over 25 years of experience in Quality and Operations Management driving improvement through the implementation of company specific quality systems which are certified to standards such as ISO 9001:2008 and PS 9000 in a range of companies which service the packaging supply chain of the pharmaceutical industry. Suzanne is a qualified IRCA auditor for ISO 9001:2008, ISO 14000 and PS 9000:2011.
Senior Project Manager
Jim Chesterman is a labelling professional with over 25 years of consulting and international project management experience in the Pharma, Medical Devices and Consumer sectors, focusing on labelling, artwork, business process, solution design and system implementation and integration.
Global Business Development Director
Mark is an industry leader and experienced professional within the global Life Science packaging and artwork sector, over the last 30 years he has built up an unparalleled wealth of knowledge, experience and understanding of the global pharmaceutical packaging supply chain. A results-driven strategist, Mark provides expert strategic advice, product guidance and relationship management to his clients. Building trust and working closely with Perigord's customers Mark's focus is on the continuous delivery of the gold level of performance needed to achieve desired results. Mark has a passion for professional and personal development to continue to bring the highest value to clients.
Key Learning Objectives
- What is the scope of Impact Analysis.
- How to minimise the level of human intervention in completing complex assessments of content changes across related documents and artwork.
- How to gain an enterprise helicopter view of your labelling and artwork projects.
- How to simplify the capture and auto transfer of labelling changes from regulatory word PI/QRD to artwork file brief.
- Senior Leaders in:
- Regulatory Affairs
- Digital Transformation
- Artwork & Packaging
- Supply Chain
- Project Management