Documentation Simplification Training
About This Course
Has your paperwork grown organically over the years? Have you added extra checks, extra fields and immense numbers of signatures in response to deviations only to find the same, or similar issues reoccurring? This pharmaceutical documentation simplification training course provides you with the 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.
If you choose our virtual learning option, training will be delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. Full details will be sent to you following registration.
Key Learning Objectives
Do your documents contain inherent risks, error traps or ambiguity? Do they contain over-complexity, poor instructions or inadequate recording space? These issues can lead to deviations and potential batch losses. You need to simplify your documents, and this course is designed to show you how.
Upon completion of this course, delegates 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 and batch documentation
- Learn best industry practices and drive out complexity
- Understand data integrity implications when completing documentation
There are also opportunities for discussion throughout the workshop, as well as real-life case study presentations.
Who Should Attend
Is your team performing badly on first-time metrics? Are your documents too long, too complicated and creating poorly completed records? Companies are facing data integrity problems more than ever before, and management teams are growing increasingly concerned.
This course is ideal for any individual/department who is responsible for documentation. From warehousing to quality, you’ll gain a better understanding of your issued instructions, record formatting and more, resulting in significant improvements to your overall documentation process.
Course tutors will be selected from the following:
Paul Merrick - An engineer by training, Paul has extensive experience of continuous improvement including document simplification projects. He has introduced the Lean process 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 percent. He has worked with many continuous improvement tools such as the 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 analyze and reduce all forms of waste.