Good Documentation Practices

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 spiraled out of control. You now have a system you can no longer afford
• Your documents are actually the root cause of many non-compliance reports, quality problems and massive inefficiencies

This course is designed to help you make your documentation system simple, effective and compliant.

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
• Centralized vs decentralized 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

Computerized 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 Lifecycle – The What, How and Who of:

• Information and data gathering
• Documentation generation, review and approval
• Validation
• Implementation (including training)
• Archiving and destruction

Venue

Glen Hove Conferencing, Johannesburg, South Africa

Glen Hove Conferencing is centrally located in Johannesburg and close to the very popular Melrose Arch Complex with its superior hotels and dining facilities. Glen Hove Conferencing is the headquarters of the Southern Gauteng branch of the South African Pharmaceutical Society.

For assistance in finding accommodation please contact the Course Convener, Dr A J Thomas on [email protected]

The courses will be held in the ultra modern Upper Glen Hove meeting room which can comfortably seat 80 persons. Acoustics in the room are excellent as is the standard of catering facilities provided. For further information please visit the conference centre’s own website at www.glenhove.co.za or email them at [email protected]

Catering

During the course, mid-morning tea plus snacks will be served at approximately 10.00 with afternoon tea served at 15.00. At lunchtime you can enjoy an appetising finger buffet served in the foyer.

After each day’s activities a closed bar service will be available, chargeable to your account where relevant.

Special Dietary Requirements

If you have any special dietary requirements, please contact the conference management.

Venue Address and Contact Details

Glen Hove Conferencing, 52 Glenhove Road
Melrose Estate, Johannesburg, 2196

PO Box 2467, Houghton, 2041

Tel: 011 442-3601
Fax: 011 442-3678

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:

• Dr Allan Thomas
  Partner
  Dip.Pharm, MPharm, DPharm, MPS(SA), MPD(IMD), CHE(NWU)

  • [email protected]
  • +27 (0) 21 558 4515
• Ms Anna Naidoo
  Consultant
  Chemist

  • [email protected]
  • +27 (0) 21 558 4515

What you've said

**Feedback received for this course in Europe*

“The course was very beneficial and provided good ideas on simple document design.”

Christopher Bate, Eisai Manufacturing, UK

“Course provided hands on practical information tips and tricks on how to keep things simple.”

Marcella Mijnlieff, DSM Anti-Infectives, The Netherlands

“Course provided good advice on how to simplify documents and work instructions.”

Gabriella Cassisa, Merck Serono, Italy