How to Audit - Devices/Combination Products
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Improving Your Auditing Skills, The How To Audit Series
Tuesday 15 to Friday 18 January 2026
York Marriott Hotel, York, UK
£2400.00 excl VAT – £2880.00 inc VAT
Type: Pharmaceutical
About this course
Determining the appropriate audit strategies when auditing a combination of drug/device and other combination products often leads to confusion, as generally an emphasis is placed by the auditor onto their most ‘comfortable’ area of knowledge.
This course aims to help you to develop the optimum strategy for your audit so that, regardless of regulation or technology, you focus upon the highest risk areas and deliver a robust summary as to the effectiveness of the lifecycle activities. We explore the regulations, risks and requirements in order to equip you with the best strategies and thought processes to deliver an objective, balanced and risk-based audit of your combination product.
Course outline
The course includes:
- Overview of the various types of combination products, particularly in the field of drug/device combinations
- Overview of the regulatory environments, governing laws, good manufacturing practices (GMP) and guidances that influence validations and controls in this area
- Case studies demonstrating the typical project plans, activities and decisions undertaken when designing a combination product
- Case studies demonstrating the typical transfer to manufacture activities and general GMP requirements for these types of products
- Case studies demonstrating the supporting after-market processes, including regulatory vigilance necessary to support these products in a regulated market
- Auditing fundamentals and developing appropriate strategies for the assessment of the design, manufacture and post-market surveillance
- Typical audit risk management plans and checklists necessary to ensure you do a good job in auditing the design, transfer, validation and quality systems
- Review of systematic and compliance based non-conformities and how to articulate this information in the form of reports and statements
The course is highly interactive and will challenge you with identifying audit strategies, undertaking audits, discussing findings and deriving conclusions relating to the effectiveness of your organisation.
We bring together a series of tutors with experience of the design, validation and auditing of combination products who, between them, represent the top five notified bodies in medical devices and the top competent authorities.
Venue
York Marriott Hotel, York, UK
The York Marriott Hotel is within walking distance of York city centre and its many attractions. With 151 stylish guest bedrooms the hotel is ideal for the business or social traveller.
Secure WIFI internet access is available in public areas and their recently refurbished Leisure Club features a heated pool, sauna, steam room, jacuzzi, gymnasium and private tennis court.
Hotel Accommodation
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Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
- To take advantage of this offer, you must book via a special weblink, details of which will be provided to you on receipt of a completed booking form.
- This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
- If you need any help or guidance with the accommodation booking process, please contact our course administration team.
- Your account with the hotel should be settled at check-out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our experts for this course are:
To be confirmed at a later date
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