Documentation and Records in GMP – A Modern Approach

This course will explode some of the myths, remove some of the complexity and re-focus upon the GMP rules and guidance and how they are applied

Explode some of the myths, remove some of the complexity and re-focus upon the GMP rules and guidance

Do you need to understand the practical day-to-day implementation of GMP requirements for documentation and records; including the current EU and USA GMP requirements for paper based, electronic and hybrid systems. Would you like to explode some of the myths, remove some of the complexity and re-focus upon the GMP rules and guidance and how they are applied regarding documentation and records in GMP?  Are you involved in the management, design or approval of documentation?  Would you like to make your documents used and easy to understand?  If so, then this course is for you.  Attend this course and you will leave with a wealth of practical tips and advice for having a well-managed documentation system. Our one-day Documentation and Records in GMP course is available on the following dates:

Course dates Venue Click below to book a place
Wednesday 20th September 2017 Reading, Berkshire, UK Picture1

If you plan to pay by credit card then you should first look at this helpful information. Alternatively, if you want to discuss any aspect of this course or want to reserve a place, please send an email with your enquiry or call +44 1635 866699.

 

Course overview:

Our Documentation and records in GMP course covers the practical day-to-day implementation of Good Manufacturing Practice requirements for documentation and records; including the current EU and USA GMP requirements.  The course covers requirements for paper based, electronic and hybrid systems.

The many different types of GMP documents and records are discussed along with the principles of version control, authorisation, issuing and control of changes.  The course also covers content of documents, and how they should be worded and laid out.  Guidance is given on how to control in-house documents and includes practical ways of managing other types of controlled company information, external reference material and publications such as pharmacopoeias and technical manuals.

The issues surrounding validation and security of certain types of record, record keeping and data management are also included, including the requirements for archiving and retrieval of information as well as the latest expectations with regard to data integrity.

The Documentation and records in GMP course also covers the use of electronic records and use of electronic signatures (including 21 CFR Part 11) explaining the different ways documents and data information can be authorised by utilizing modern technologies.

Who will the course benefit?

This course will suit new, as well as established, Document Controllers, QA and QC personnel and technical personnel involved in generating, approving and using GMP documentation and records.  The Documentation and records in GMP course is full of practical tips and advice for having a well managed documentation system will explode some of the myths, remove some of the complexity and re-focus upon the rules and guidance and how they are applied.

Course location:

UK courses (Reading, Berkshire)
The Holiday Inn – Reading South, 500 Basingstoke Road, Reading, Berkshire, RG2 0SL, UK. The hotel is very close to Junction 11 of the M4 – 25 miles west of London’s Heathrow Airport.
Telephone: + 44 (0)871 942 9067
e-mail: [email protected]
Web: http://www.hireadingsouthhotel.co.uk
A special rate of £121 (including VAT) has been agreed with the hotel (subject to availability). This is for Bed and Breakfast and includes internet access. Quote “Inspired Pharma” when making your booking.

Course cost:

£595  per delegate plus VAT. Course will be charged in GB pounds.

VAT will not be charged for courses held outside the UK. VAT will be charged for the courses held in the UK, however delegates from outside the UK but within the European Union (EU) will not be charged VAT if they supply their own company’s national VAT number when booking. VAT will not be charged for any delegates coming from outside the EU.

The cost of accommodation is not included in the course cost. If required you should book accommodation yourself directly with the hotel.

The cost includes:

  • Refreshments and lunch during the course times.
  • Course folder containing copies of slides and supplementary notes and handouts.
  • Course attendance certificate.
  • Full tutor support and access during course times.

Payment can be made by cheque, electronic transfer, credit or debit card. Payment must be made before the course start date. Either payment or a Purchase Order number will be required to secure a place on the course.

To book a course please use the online booking system by selecting the ‘Book Now’ button on the event of your choice (at the top of the screen/page)

Feedback from previous delegates:

“I would recommend this training course to anyone else in a document management role “
Admin Officer, Clinical BioManufacturing Facility

“Brilliant – thank you”
Document Control Officer, GW Pharma

“Excellent – a good overview of the subject”
Quality Executive, GSK

“Very good”
Document Control Specialist, CooperVision

“Excellent and interesting”
Document Control Assistant, GW Pharma

Dates:

See top of this page for current public dates. Also available for in-house delivery, and may be customised if required.

Times: 

 09.00 – 16.30.

Tutors

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Dominic Parry

Dominic Parry has worked in the pharmaceutical industry since 1992, and is a leading pharmaceutical quality management specialist. He worked for 4 years at Evans Medical Limited (now Novartis Vaccines) as a Production Development Scientist. He then moved to Hoechst Marion Roussel (now Patheon, UK), where he worked for 4 years as a Quality Assurance Officer and then Validation Manager for the sterile manufacturing operations.Over the past 15 years he has worked as a leading pharmaceutical GMP trainer and Quality Management System specialist. He works closely with pharmaceutical companies and their suppliers on evaluating, developing and continually improving their quality systems.He is generally recognised as one of the leading GMP trainers in the UK and brings an enormous amount of interest, enthusiasm and fun into the training he presents. He is Managing Director of Inspired Pharma Training Ltd.

 

martin-lale

Martin Lale

Martin Lale has worked within the pharmaceutical and packaging industries since 1978 and is now focussing on consulting. Martin worked at Wellcome for 10 years within Packaging Development, before moving to Bristol Myers Squibb to become the Nightshift Operations Manager for a further 4 years. He has also worked for Mallinckrodt Animal Health, Eli Lilly and GSK in a variety of supply chain and leadership roles over 20 years. In the last few years he has worked on implementing new quality systems and helping suppliers improve their performance. He is recognised as improving quality and performance, along with making significant step changes to re-engineer the supply chain to meet increasing customer needs.

Course content
  • GMP requirements for documents and records
  • Why control documents and information?
  • Different types of documents and records and their content
  • Good document and record design
  • Approval of documents
  • Paper versus electronic systems
  • Use of electronic signatures
  • Completion of records
  • Data integrity
  • Archiving and retrieval of paper based and computer based systems
  • Common regulatory findings

Documentation Records GMP