Brought to you by: Perigord Life Science Solutions

Webinar On-Demand Access

Webinar: Digital Evolution in Impact Analysis for Regulatory Labelling and Artwork Changes

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
  

Key learning objectives you will learn during this session:

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 touch-points 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.

Who should attend

Senior Leaders in: 

• Regulatory Affairs
• Digital Transformation
• Artwork & Packaging
• Supply Chain
• Quality
• Procurement
• Operations
• Project Management

Tune-in now to learn how you can overcome and manage the challenges of constant change in the end-to-end labelling and artwork process.

Meet the Experts

Suzanne Ivory

COO, Software Division

Perigord Life Science Solutions

Suzanne has over 25 years of experience in Quality and Operations Management and was involved in the development of PS 9000 which is a quality standard that was specifically created for the packaging supply chain of the pharmaceutical industry. Suzanne is a qualified IRCA auditor for a range of standards.

Jim Chesterman

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.

Mark Ennis

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.

Brian Cox

Brian Cox is an experienced Artwork Management professional with over 20 years working in Perigord Life Science Solutions. In his role as senior Business Analyst, Brian works directly with Perigord leading pharmaceutical clients across many aspects of the artwork production process and understands fully the complexities clients face when assessing the impact of an safety change.