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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.

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Make a Booking

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

Tuesday 23rd Febrary 2021

Venue: Your home or workplace using our proven ‘live online interactive’ courseware

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.

All Dates:

The cost is £695 plus VAT. Course will be charged in GB pounds. For full details of what is included in the cost see below.

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.

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.

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:

£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.

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.

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

Live Online Interactive Training

Stay Safe - Attend from home or whilst at work

With 2 expert facilitators and a maximum of 10 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?

We will send you a link to the live online interactive course with your joining instructions once you have booked your place. 

You should log into the training session 10-15 minutes before the start time, to ensure that you have set up the courseware  correctly. The course will start precisely on time and it may not be possible to go back over material missed by late arrivals.

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.

I found the interaction very good by using the chat option as it keeps everyone interested and there was a variety of questions and answers.

Quality / EHS Specialist, DCC VITAL

Great course, although it was virtual I felt we got the same value for money as if it was F2F, a 10 out of 10!!! I will recommend to colleagues

Quality Executive, ABPI

The GMP course was ran very well. Both presenters were very knowledgeable in the area, both for the EU and other countries. I would highly recommend this course to those who are new to the area of GMP, as well as those who just need a bit of a refresher.

 

Training Officer, THORNTON & ROSS

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

Excellent and interesting

Document Control Assistant, GW PHARMA

Excellent – a good overview of the subject

Quality Executive, GLAXOSMITHKLINE

Very Good

Document Control Specialist, COOPERVISION

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:

2020

September 

29 Advanced GMP

October

06 Responsible Person

06 Data Integrity 

09 Good Distribution Practice

12 Pharma GMP Lead Auditor

20 Good Manufacturing Practice

21 Sterile Products

November

10 Internal Auditor

16 Pharma GMP Lead Auditor

24 Problem Solving

30 Pharma GMP Lead Auditor

December

08 Responsible Person

15-17 Multi-day GMP

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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