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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. This course is delivered using our proven 'live online interactive' courseware enabling you to attend the course from your home or workplace and be heard and seen throughout, just as you would be if we were in a room together.
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.

Some key features of our GMP Documentation and Records course:

Lively and highly interactive course

Our course format is designed to ensure that  this is a lively and highly interactive course with practical workshops and exercises throughout the programme. See the incredible feedback from delegates about our ‘live online interactive ‘ courses  in this article.

Maximum class sizes

For maximum interactivity and effectiveness, our class size is limited to  either 10 delegates  (live online interactive)  or 12 delegates (classroom) with at least two tutors. The quality and effectiveness of our courses is unrivalled in the industry.

Make a Booking

Our one-day GMP Documentation and Records training course is available on the following dates:

2021

Venue for all dates: Your home or workplace using our proven ‘live online interactive’ courseware. From the list below select the date you want to make a booking (dates in blue are ‘Waiting List’ only):

Tuesday 7th Septmeber 2021

Click here to book

Booking details

Select the tabs below to find out all the details you need to know to make a booking:

Course cost

£695  per delegate plus VAT. Course will be charged in GB pounds.

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.

What's included in cost

The cost includes:

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

Payment

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 RP training course or want to reserve a place, please send an email with your enquiry or call +44 1635 866699.

Based Outside the UK?

If so, be sure to pick the ‘Tax Exempt’ options in the payment method list when you are  making a booking. If you are based in the EU then you must also enter your VAT number to qualify to be exempt from VAT.

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.

Coronavirus Update

Due to the uncertainties involved in travel at the moment we will be delivering all of our public courses using our proven ‘live online interactive’ technology. Delegate feedback from the courses we delivered in June and July has been just as positive as our classroom courses and in addition, many people have enjoyed not having to travel in these difficult times

Key Course Information

Is this course right for you?

Click on the tabs below to find out if you will benefit from attending this course:

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 Times:

09.00 – 17.00 consisting of four 90 minute live interactive online sessions and 3 breaks of at least 30 minutes

Course Details

Click on the tabs below for more details on the content of the course:

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.

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

Live Online Interactive Training

This course is currently only available using our proven ‘live online interactive’ format. Select the tabs below to find out more:

Stay Safe - Attend from home or whilst at work

With 2 and sometimes 3 expert facilitators and a maximum of 8 delegates our course will utilise state-of-the art interactive online classroom software that will enable you to:

  • chat online with the facilitators and other delegates
  • raise your ‘virtual’ hand to ask a question
  • participate anonymously in a poll or survey and see an instant display of the class results
  • undertake exercises on your own or in a group

And best of all no travel is needed nor a stay in a hotel reducing any risks of COVID-19 and saving you a lot of time, hassle and money.

 As always we will ensure this event is inspirational, enjoyable and educational. See the feedback below:

What is involved?

For this certified course IRCA lay down strict requirements in terms of the hours of learning (40+), continuous assessment and the supervision of the exam. This means that you will need to undertake just over 3 hours of online learning prior to the 5 day event and that the event itself will be very intensive and includes evening work – see Timetable details above. It is very important that during the 5-day event you focus totally on the course and that distractions are minimal.

We will send you detailed joining instructions once you have booked your place and in sufficient time for you to undertake the pre-course work.. 

Your active participation is expected: everyone will be heard and seen throughout, just as they would be if we were in a room together. To be heard, hear and be seen you will need a microphone, speakers and camera — if you have a modern laptop that’s all you will need. Remember, you’ll need a quiet place to call from and a decent internet connection is a must.

Why choose Inspired Pharma?

Expert Tutors

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 has worked in the pharmaceutical industry since 1992 and is a leading pharmaceutical quality management specialist.  He initially worked for Evans Medical Limited as a Production Development Scientist.  He then moved to Hoechst Marion Roussel where he worked as a Quality Assurance Officer and then Validation Manager for the sterile manufacturing operations.

Over the past 20 years he has worked as a leading pharmaceutical trainer and Quality Management System specialist.  He works closely with pharmaceutical companies and their suppliers on evaluating, developing and continually improving their quality systems so that they add real-value to organisations.  He has a real passion for training in the pharmaceutical industry and has presented GMP and Quality Management related training courses all over the world.  He is an IRCA registered GMP Lead Auditor and regularly performs audits of pharmaceutical companies and their suppliers.

Matt is a dynamic, energetic and authentic trainer who demonstrates his passion and communicates this to all who encounter him. He began his Pharma career at Napp Laboratories before having short spells in related industries. He then spent 15 years with GlaxoSmithKline gaining extensive knowledge of GMP from roles in Packaging, Logistics and QC.

More recently, Matt worked as GMP Learning and Development Manager for Lonza Biologics and draws on all his varied experience to create a lively, relevant training environment.

Delegate Feedback

Excellent and interesting

Document Control Assistant, GW PHARMA

Very Good

Document Control Specialist, COOPERVISION

Excellent – a good overview of the subject

Quality Executive, GLAXOSMITHKLINE

Brilliant – thank you

Document Control Officer, GW PHARMA

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

Admin Officer, CLINICAL BIOMANUFACTURING FACILITY (OXFORD)

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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.

Quick Links

Find your way quickly to any part of our website by selecting any of the links in this section:

Forthcoming Public Courses

All of our public courses are being delivered using our proven 'live online interactive' courseware enabling you to attend the course from your home or workplace and be heard and seen throughout, just as you would be if we were in a room together.

Click on course name for full details:

2021

April

26 Pharma GMP Lead Auditor

May

05 Sterile Products

11 Internal Auditor

17 Pharma GMP Lead Auditor

26 Responsible Person

erson

Online courses available anytime anywhere 

Data Integrity

Good Distribution Practice (GDP)

Good Manufacturing Practice (GMP)

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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