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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.

Key Course Information

Is this course right for you?

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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

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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

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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Annex 1 2022 Section 10: Quality Control (QC)

This final article looks at the new requirements in section 10 on Quality Control. It is also a useful point at which to reflect on the 2022 version of annex and what might it mean.

Annex 1 2022 Section 9: Environmental and Process Monitoring

This article is covering section 9 which describes the annex 1 guidance for Environmental and Process Monitoring. Section 9 is now a centralized location for monitoring activities.

Annex 1 2022 Section 8: Production and Specific Technologies – part 3

In this final part of the article on section 8 we will look at Sterilization processes. The selection of a sterilization process should be based on scientific principles.

Annex 1 2022 Section 8: Production and Specific Technologies – part 2

This is the second part of the article covering section 8 of Annex 1 2022 and here we are looking at the requirements around Form fill seal and Blow fill seal.

Annex 1 2022 Section 8: Production and Specific Technologies – part 1

This next article in our series is about section 8, which is the largest section of Annex 1 and covers production and specific technologies

Annex 1 2022 Section 7: Personnel

In this article, we move onto the personnel section, section 7.

Annex 1 2022 Section 6: Utilities

In this article we expand upon the equipment section but looking at Utilities as described in section 6.

Annex 1 2022 Section 5: Equipment

In this article we look at the general requirements for the equipment used in the manufacturing of sterile products.

GMP News and Articles

Read our articles on  GMP regulatory developments as well as news about our GMP training courses.

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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Our Public Course range

Most of our public courses are currently 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. In 2022 we began to once again offer traditional classroom courses - see details on each course page.

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Pharmaceutical GMP Auditor/Lead Auditor

Advanced Good Manufacturing Practice

Good Distribution Practice

Good Manufacturing Practice

Internal Auditor

GMP Problem Solving

Responsible Person (RP)

Sterile Products

Webinar: Microbiological control in pharmaceutical production 

QP Courses - full range

See and download our Auditing Brochure detailing our courses and services in this important area.

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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