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Technical Training Courses

Introduction to the FDA

This is a focussed one-day course which helps to remove the fear-factor from FDA inspections. It provides information on the roles, responsibilities, inspection procedures and outcomes of the US FDA. It also offers a tried, tested and successful method of inspection management.

The course covers the following:

• The FDA organisation and their remit
• QSIT - Quality Systems Inspection Technique
• Explore the US regulations (QSR)
• Inspection management techniques
• How to prepare the organisation for the FDA visit (back room techniques etc)
• Key roles during an inspection
• Non-conformances,483,482, Warning Letters and Establishment Inspection Report (EIR)

Call us for a confidential discussion on your individual needs. Phone us on 01463 797458 or email us at info@invereach.com 

SME (Subject Matter Expert) training

During a regulatory inspection a number of company employees will be required to interface with the inspector. It is important that these employees are confident and knowledgeable in what they say and how they say it. The performance of these Subject Matter Experts (SME) can determine the success or otherwise of an inspection. This half-day interactive course takes the fear-factor out of performing this role during an inspection.

The course teaches the delegate the following:

• The importance of the role of the SME
• Differences between the approaches of the FDA, MHRA and notified bodies
• What questions the FDA will ask
• How not to answer the questions
• What to do if there is a problem
• How to answer an inspection finding

Those employees likely to be on the front line during an inspection should attend this course. 

 Call us for a confidential discussion on your individual needs. Phone us on 01463 797458 or email us at info@invereach.com

This course allows companies to meet compliance obligations by having all their staff trained in GMP. Overview and refresher training, completed in a one-day course, covering the GMP requirements and regulatory framework for the design, production and distribution of medical products.

The course covers the following:

• Special nature of medicines and medical devices
• Regulatory framework of FDA, notified bodies, competent authorities
• 7 subsystems of the QSR
  • Design controls
  • Production & process controls
  • Document controls
  • CAPA
  • Purchasing controls
  • Distribution controls
  • Facility and utility controls
• Validation
• DMR/DHR/DHF definitions, differences and requirements
• Example 483 citations and warning letters

Call us for a confidential discussion on your individual needs. Phone us on 01463 797458 or email us at info@invereach.com 

The product stability course provides the cornerstone for professionals working within the medical device industry. a must-do course for quality and regulatory staff whose responsibilities include creation of, review of or interpretation of product stability data. Highly valuable to production and R&D staff who make technical or project based decisions. The one-day course takes a thorough and logical pathway through the regulations, guidelines and industry practices that drive product stability requirements. Interactive exercises ensure that the course remains interesting and indeed enjoyable. Theoretical and practical examples are used throughout.

The course covers the following:

• Reason for stability
• How much shelf-life is required
• World climate zones
• Use of ICH guidelines
• Storage conditions and time periods
• Arrenhius equation and 1^st order reactions
• Stability indicating testing and use of controls
• Protocol preparation
• Storage - in-house or sub-contract
• Controlled unit validation
• Practical examples

Call us for a confidential discussion on your individual needs. Phone us on 01463 797458 or email us at info@invereach.com   

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As required by ISO13485 and the FDA Quality System Regulation, companies must audit themselves and their suppliers.

This one-day course equips the delegate as an effective auditor. The course includes sections on how to plan the audit, the use and limitations of checklists and tips regarding audit execution. It covers audit closure and the issue of non-conformances. Most importantly, the course merges together the need for regulatory compliance through audit, with the real, tangible business benefits available from the effective use of audit. Many suppliers to Medical Device companies find themselves without expertise in the regulations surrounding the industry. This provides a challenge to a vendor auditor. In the course, we explore these challenges, providing practical and valuable solutions to ensure success for the delegates in their future vendor audit experiences.

Call us for a confidential discussion on your individual needs. Phone us on 01463 797458 or email us at info@invereach.com    

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This two-day intensive course is designed to equip the delegate with a thorough understanding of the requirements of process and equipment validation, in order to satisfy both US and EU regulations. Featuring practical exercises, example protocols, real scenarios and illustrating common pitfalls, the course is interactive and interesting, as well as being informative and thorough.

Covering the validation life-cycle from beginning to end, this course is a must-do for those quality professionals whose responsibilities include creation of, review of or interpretation of validation protocols, data or reports. The course is also a highly valuable asset to production and R&D staff who install and bring into service new equipment for use in production or development environments. The course covers detailed sessions on Validation Master Planning, USR generation, IQ, OQ, PQ and PPQ.

The importance of Test Method Validation (TMV) and Computer System Validation (CSV) and how they inter-relate to process and equipment validation is explained and practised during the course, as are the special requirements of statistical sampling in validation, protocol creation and reporting. The course concludes with expert help on evaluating process risk and where possible, demonstrating equivalence between processes and products and the impact of equivalence on the validation system.