Good Documentation Practices
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One of the key Quality Systems that continues to provide a challenge to businesses who fail to implement a simple system that everyone can follow
Tuesday 17 to Wednesday 18 July 2025
Hotel Michelangelo, Milan, Italy
€1200.00 excl. VAT (first booking)
€1080.00 excl. VAT (AFI Member price)
€960.00 excl. VAT (additional bookings from same site)
- delegates are eligible for only one discount type
Type: Pharmaceutical
About this course
The Pharmaceutical Industry generates vast amounts of documentation of all types, shapes and sizes. Documents are intended to assist manufacture and assure compliance.
However, for many companies, documentation systems have become a major business and regulatory concern. For many of you:
- Your documentation systems have become so complex they are almost unworkable
- The number of procedures and policies has spiralled out of control. You now have a system you can no longer afford
- Your documents are actually the root cause of noncompliances, quality problems and massive inefficiencies This course is designed to help you to make your documentation system simple, effective and compliant.
What You Will Learn
- Current industry best practice for document design and control
- How to avoid unnecessary complexity
- How to write documents that people can use and reduce errors due to non-compliances and ‘human error’
- How to get the best from YOUR documents
Who Should Attend
This course is for anyone involved in…
- Designing documents and documentation systems
- Managing documentation systems
- Writing documents
- Reviewing and approving documents
Course outline
Good Industry Practices – Learning from the Best
- How to reduce the number of unnecessary documents
- How to make your documents simple, understandable and usable
- How to dramatically improve procedural compliance
- How to generate good quality documents faster
Designing a Documentation System that Works! – The What, Why and How of:
- Corporate policies
- Site (local) policies
- Standard Operating Procedures
- Centralised vs decentralised systems
How to Write Policies and Procedures that Actually Work
- Design tools and techniques
- Language, style and readability
- What to include and how to avoid information overload
Getting Down to Specifics – Practical Guidance on the Structure and Essential Content of:
- Policies
- Standard Operating Procedures
- Log books, records and reports
- Work instructions
- Deviations and quality incidents
Computerised Systems – Getting the Basics Right
- Electronic records and signatures: principles and practice
- The most up-to-date regulatory expectations relating to validation and operation
- Managing the transition from paper to paperless
The Document Life Cycle – The What, How and Who of:
- Information and data gathering
- Documentation generation, review and approval
- Validation
- Implementation (including training)
- Archiving and destruction
Venue
Hotel Michelangelo, Milan, Italy
Hotel Michelangelo is an impressive building around the corner from Milano Centrale Train Station. It offers well-designed, modern rooms with spa bath, free minibar and free wired internet.
Rooms are soundproofed, and equipped with air conditioning and a TV with satellite channels. The generous buffet breakfast includes cold and hot dishes.
Hotel Accommodation
- It’s your responsibility to book any rooms you may require directly with the hotel either by phone (Tel. +39 0267551) or on-line at www.michelangelohotelmilan.com
- Your account with the hotel should be settled at check out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our experts for this course are:
What you've said
“The course was very beneficial and provided good ideas on simple document design”
Chris Bate, Eisai
“Course provided hands on practical information tips and tricks on how to keep things simple”
Marcella Mijnlieff, DSM
“Course provided good advice on how to simplify documents and work instructions”
Gabriella Cassisa, Merck Serona SpA
An NSF International Company