Combination Products Regulations and Requirements Course

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The distinction between Pharmaceuticals and Medical Devices, once clear-cut, has become increasingly blurred leading to the emergence of regulations, governing Combination Products that are part Medical Device and part Pharmaceutical or Bio-pharmaceutical. Regulatory requirements for Combination Products, and the expectations of regulatory agencies, differ in subtle ways between the US and Europe. This one-day course gives a clear oversight of the regulations and expectations from both sides of the Atlantic. The course is aimed personnel at all levels within an organization, who have responsibilities relating to the development, production and placing on the market of Combination Products in the US and Europe.

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Introduction to Combination Products Regulation

Regulations and Guidance Documents that apply
CE Marking and Medical Device Classification
Registering a Medical Device in the US
Registering a Pharmaceutical product in the EU
Registering a Pharmaceutical product in the US
Differences between Medical Device and Pharmaceutical Quality Systems
Medical Device Design Controls
Pharmaceutical and Medical Device Vigilance
Parties Involved and their responsibilities
Practical Exercises and Discussions

R&D Product Development Engineers and Management
QA Personnel
Supply Chain Personnel.
Regulatory Affairs Personnel
Sales Staff
Any personnel in the Medical Device or Pharmaceutical Industries involved in the development, validation or registration of Combination Products

On successful completion of this training course, delegates should be able to:

State the EU and US Definitions of a Combination Product
State the main Regulations governing Combination Products
Identify and source the Harmonised Standards and Guidance documents related to Combination Products.
Understand the Medical Devices Regulation 2017/745 and the process for CE Marking
Understand the process for registering Medical Devices in the US
Understand the process for registration of Pharmaceutical products in the EU
Understand the process for registering Pharmaceutical products in the US
Describe salient elements of the FDA Quality System Regulation 21 CFR Part 820 and ISO 13485 and how they differ from Part 210/211 and EU GMP Vol 4.
State the main requirements for Design Controls form FDA Quality System Regulation 21 CFR Part 820 and ISO 13485
State the main requirements of 21 CFR Part 4
State the main requirements of the EU Medical Regulation 2017/745 and ISO 13485 in relation to Combination Products
State the main requirements of the EU Medical Regulation Directive 2001/83/EC and EU GMPs Vol 4 in relation to combination products.
Identify the main differences between
State the requirements for Medical Device vigilance and Pharmaceutical post market surveillance
State what each party is responsible for a given product scenario.
State what each party is responsible for a given outsourced product scenario.

Gerry Burke

Gerry is a self-motivated medical industry professional with kn...

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John Lafferty

John Lafferty is a Quality professional with over 25 years expe...

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In-House Courses
Course tutor will contact your organisation in advance to discuss the programme in detail.
In-house courses can be customised to meet your organisation’s specific requirements.

Course Manual
Delegates will receive a hardcopy course manual with relevant course materials.

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Snapshot

Course Code

LS042

Duration

1 training day

Delivery Mode

This programme is delivered by or In-Company training

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