How to Prepare for and Host a FDA Inspection and Avoid 483’s (based on practical experience)

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Medical Devices
How to Prepare for and Host a FDA Inspection and Avoid 483’s (based on practical experience)

Bookmark Add to Calendar 2017-09-21 13:00:00 2017-09-21 14:00:00 America/New_York How to Prepare for and Host a FDA Inspection and Avoid 483’s (based on practical experience) Live SignupTraining hello@signuptraining.com

How to Prepare for and Host a FDA Inspection and Avoid 483’s (based on practical experience)

4094

Duration : 60 Minutes

Edwin Waldbusser, Medical Device

Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, softwa Read more

Description

In this webinar you will learn about the types of FDA inspections, necessary preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection, the value of mock audits, how company personnel should conduct themselves during the inspection, how the inspection will unfold and how to respond to 483’s.

Course Objective:

• Types of inspections
• Preparation

o Dedicated personnel for inspection
o Facility resources to support the inspection
o Internal audits
o Mock audits

• SOP for inspections
• Behaviour during inspection-what to say, what not to say
• Inspection process
• 483 response process

Course Outline:

Topics covered include:

• Types of FDA inspections
• Inspection SOP preparation
• Preparation –people, facilities
• Mock audits
• How the inspection proceeds
• Responding to 483’s

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional):
• Reward Points

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

Medical device development/ manufacturing

• Regulatory management
• Engineering
• Corporate Management
• Quality Assurance
• Quality Control

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Duration : 60 Minutes

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How to Prepare for and Host a FDA Inspection and Avoid 483’s (based on practical experience)

Duration : 60 Minutes

Edwin Waldbusser, Medical Device

Description

Webinar

Live

Recorded Options

Recording - Single License

CD-DVD

Flash Drive

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

100% MONEY BACK GUARANTEED

Get In Touch

Similar Trainings

Understanding Combination Products: Navigating the Rules and Regulations

LIVE : Scheduled on 30-April-2024 :01:00 PM EDT

European Union Device Regulation (EU MDR)

LIVE : Scheduled on 01-May-2024 :01:00 PM EDT

Risk Based Design Control

LIVE : Scheduled on 15-May-2024 :01:00 PM EDT

More Trainings By : Edwin Waldbusser

European Union Device Regulation (EU MDR)

Medical Device - Engineering Change Control

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