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Your experienced training specialists

Mr Paul Shane Bennetts

M. Devices Group

Mr Bernard Tremaine

Associate with M. Devices Group

TRANSFER KNOWLEDGE TO FAST TRACK YOUR FDA PROGRAMME & MOVE AHEAD OF YOUR COMPETITORS

The Course Benefits

This is a technically focused practical training courses to help develop a FDA compliance programme, covering:

• Understanding Quality & Regulatory Requirements

• Developing Regulatory Compliance Status

• Understanding the Difference with European Requirements

• Knowing about the 510(k) Submission Process

• Learning about Post Market Issues

• How to manage an Inspection by the FDA

Who Should Attend

• Regulatory Assurance

• Quality Assurance

• Internal Auditors

• Managers whose department’s will be audited

How to Quickly achieve

Regulatory Compliance

with the

CFR 21 Regulations &

New Requirements

Dates By Arrangement

FDA

FDA

FDA Compliance in Europe

Location: Client’s Premises

Two Day

Course

Fees £450 per delegate Book 2 for £399 each or £1800 per Company

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