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Documentation and Records in GMP – A Modern Approach

Our 1-day GMP Documentation training 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 Key informationWhy Inspired

This 1-day GMP Documentation training course will explode some of the myths, remove some of the complexity and re-focus upon the GMP rules and guidance

Our 1-day GMP Documentation training course will help you 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 in relation to 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 GMP Documentation training 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.

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Make a Booking

Our one-day Data Integrity training course is available on the following dates:

Wednesday 6th November 2019

Venue: Reading, Berkshire UK

Tuesday 25th February 2020

Venue: Reading, Berkshire UK

Tuesday 15th September 2020

Venue: Reading, Berkshire UK

All Dates:

The cost is £650 plus VAT. Course will be charged in GB pounds. The cost of accommodation is not included in the course cost. For full details of what is included in the cost see below. To find out more the venue select the link in blue in this sentence.

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.

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.

Group Bookings - discounts of up to 50% 

Book 2 or more individuals from the same company for the same course date to enjoy substantial discounts. The first booking is charged at the full published rate with the second booking charged at full published rate minus 20%. A third or fourth booking is charged at full published rate minus 50%. These discounts are applied automatically when you make a booking.

Key Course Information

Course overview:

Our GMP Documentation training 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 the 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 GMP Documentation training 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.

TAKE NOTE! We now have a 20-minute online Data Integrity course designed to bring your team up to speed on this important topic – click here for more details.

Who will the course benefit?

This GMP Documentation training 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 GMP Documentation training 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 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

Course cost:

£650  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.

Times: 

 09.00 – 16.30.

Venue details

Reading, Berkshire, UK

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.

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Why choose Inspired Pharma?

Expert Tutors

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.

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.

 

Delegate Feedback

I would recommend this training course to anyone else in a document management role

Admin Officer, CLINICAL BIOMANUFACTURING FACILITY (OXFORD)

Brilliant – thank you

Document Control Officer, GW PHARMA

Excellent – a good overview of the subject

Quality Executive, GLAXOSMITHKLINE

Very Good

Document Control Specialist, COOPERVISION

Excellent and interesting

Document Control Assistant, GW PHARMA

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About Inspired Pharma

We help people in Pharma organisations to continually improve their regulatory systems to gain competitive advantage and ensure compliance.

We offer a wide range of highly praised and respected classroom and online training courses and also provide our global pharma clients with consultancy support. Our classroom courses are available on a public schedule and also can be customised for inhouse delivery at a client site.

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Forthcoming Public Courses

September

23 Pharma GMP Lead Auditor

October

8 Data Integrity

10 Good Manufacturing Practice

15 Responsible Person

22 Advanced GMP

November

Pharma GMP Lead Auditor Manchester, UK

6 Documentation and Records

7 Good Distribution Practice

12 Pharma Internal Auditor

19 Sterile Products

26 Pharma Problem Solving

December

Pharma GMP Lead Auditor 

All pharma training courses held in Reading UK unless stated otherwise. Click on course name for full details.

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Good Distribution Practice (GDP)

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Pharma Quality Management Systems module

QP Medicinal Chemistry & Therapeutics module

QP Quality Management Systems module

Each course typically consists of 10-20 minute chapters of content followed by a quiz based assessment. The QP courses feature tutor assessment too. The learning is accessed over the internet using desktop computers, laptops, tablets and even smartphones.

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