FDA Inspection and Respond to 483 & How to Prepare them - 2017
Overview:
In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection.
Why should you Attend:
FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483's than a disorganized company. If a 483 is received knowing how to respond will lessen chances of receiving a Warning Letter.
Areas Covered in the Session:
Personnel Preparation
Facility needed to support inspection
Behavior during inspection-what not to sign
Internal/ Mock audits
483 response
Who Will Benefit:
Engineering Personnel
Engineering Management
Quality Management
Corporate Management
Manufacturing Management
Division Management
Speaker Profile:
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection.
Why should you Attend:
FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483's than a disorganized company. If a 483 is received knowing how to respond will lessen chances of receiving a Warning Letter.
Areas Covered in the Session:
Personnel Preparation
Facility needed to support inspection
Behavior during inspection-what not to sign
Internal/ Mock audits
483 response
Who Will Benefit:
Engineering Personnel
Engineering Management
Quality Management
Corporate Management
Manufacturing Management
Division Management
Speaker Profile:
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
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