Online Training 2015 - Process Validation with a Product Lifecycle Concept to Meet FDA Requirements - By Compliance Global Inc

Overview:
Process validation training activities with a product lifecycle management concept and the FDA risk management framework is critical for the medical device industry, because most of the device failures happen from inadequate processes and poor process control systems. Manufacturers of medical devices must meet the requirements of the Quality System regulation for medical devices (21 CFR part 820). The Quality System regulation at 21 CFR 820.5 states that “each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device manufactured
Proper quality control programs help to control or eliminate manufacturing defects. FDA also believes that incoming material and in-process control validations will assure high quality.
Why Should You Attend:
Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. Too many processes and too many validations are likely to result in too much time and money wasted in addition to FDA warnings. This webinar teaches you how to minimize process controls and process validations.
Areas Covered in the Session:
FDA quality systems requirements
Requirements for design and development planning
Requirements for process inputs
Requirements for process outputs
Requirements for process design review
Requirements for process verification
Requirements for process validation
Packaging and labelling process controls
Requirements for process changes
Maintenance and inspection of equipment
Control, use, and removal of manufacturing materials
Device master record
Learning Objectives:
Learn to minimize the need for process validation
Understand the principles of designing a robust process
Learn to look for advanced warnings of process going out of control
Learn how to prevent process defects for permanently
Who Will Benefit:
Senior management
All manufacturing/production managers
Manufacturing and production engineers
Manufacturing supervisors
Quality assurance staff
Regulatory affairs staff
Production operators
Level:
Beginner
For more detail please click on this below link:
https://www.complianceglobal.us/product/700054
Email: referrals-AT-complianceglobal.us
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Tel: +1-516-900-5515