Course Overview

Has your paperwork grown organically over the years? Have you added extra checks, extra fields and immense numbers of signatures in response to deviations and yet still find the same issues, or similar, repeat themselves? This workshop will provide you with practical tools to help you maximize the potential of your operation by significantly simplifying your documentation and the content of procedures. This will improve the design of batch manufacturing/packaging records.

Why You Should Attend

Do your documents contain inherent risks, error traps or ambiguity? Do they contain over-complexity, poor instructions or inadequate recording space? These issues will lead to deviations and potentially batch losses. You need to simplify – find out how on this workshop.

By The End Of This Workshop, You Will…

By The End Of This Workshop, You Will…

  • Know the causes of complexity and how to measure it
  • Know the regulatory expectations on good documentation practices and recent deficiencies in this area
  • Learn the process to simplify records – procedures, batch documentation
  • Learn best industry practices in order to drive out complexity
  • Understand data integrity implications when completing documentation

There will also be opportunities for discussion throughout the workshop and real life case studies will be presented. 

Who Would Benefit

Is your team performing badly on right first time metrics? Is your management team increasingly concerned as more companies are facing data integrity problems than ever before?

From warehousing to quality this course is ideal for any individual/department who is responsible for documents that are too long, too complicated and result in poorly completed records.

Improve the understanding of your issued instructions, the format that you provide for the record to be completed in and consequently improve your documentation right first time.
 

Facilitated By

Paul Merrick - An engineer by training, Paul has extensive experience of continuous improvement including document simplification projects. He has introduced LEAN philosophy to a leading UK manufacturing company, interacting with and leading cross-functional teams on strategic projects with objectives to reduce lead times by at least 50%.  He has worked with many continuous improvement tools such as Kaizen Blitz process, OEE, Gemba Kanri and 5S, leading to long-term sustainability and embedded continuous improvement techniques.

Catherine Kay - A chemist by training, Catherine has more than 23 years’ experience in pharmaceutical operations management and quality assurance.  She is passionate about keeping things simple and ensuring continuous improvement is part of daily operations.  This was a major part of her role when setting up the systems, procedures and batch records at a new oral solid dose facility.  She has experience in lean manufacturing and in her role in operational excellence, she was keen to analyse and reduce all forms of waste.

Workshop Fees

Course cost (excluding VAT) £695.00

DISCOUNTS AVAILABLE

Early bird and multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators and charities - contact us for details.

Have a question or want to book a place? Contact pharmacourses@nsf.org - you can also register online by clicking below.

Register