Overview: This course provides regulatory/quality professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program.
The purpose of this course is to provide an introduction to the fundamentals of process validation, explaining how, when, where and why one should validate. Participants will learn how to comply with FDA and international regulations for validation protocols.
Attendees will also learn how to maintain adequate validation documentation systems and perform equipment qualifications and process validations, and evaluate the need for re-validations.
Why you should attend: The guideline on "General Principals of Process Validation" was issued in May, 1987, and since then, medical device companies have struggled with process validation. Regulators believe through careful design and validation of the process, a manufacturer can establish a high degree of confidence that all manufactured units from successive lots will be acceptable. Successfully validating a process reduces the dependence upon in-process and finished device testing. Routine finished device testing is often insufficient to assure product quality. In some cases, destructive testing is required to show that the manufacturing process is adequate. End-product testing may not reveal product variations that can occur which may impact safety and effectiveness.
Areas Covered In the Seminar:
* What is Validation?
* When should it be used?
* How does it differ from verification?
* Validation vs. Verification: Which One?
* Protocol preparation
* Different types of validation
* IQ, OQ, and PQ
Who will benefit: This webinar is targeted toward professionals involved in meeting FDA's Quality System Validation requirements:
* Validation Specialists/Managers
* Process Engineers
* Manufacturing Engineers
* Quality Engineers
* Product/Process Development personnel
* Research and Development personnel
* Quality/Regulatory Personnel
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
The purpose of this course is to provide an introduction to the fundamentals of process validation, explaining how, when, where and why one should validate. Participants will learn how to comply with FDA and international regulations for validation protocols.
Attendees will also learn how to maintain adequate validation documentation systems and perform equipment qualifications and process validations, and evaluate the need for re-validations.
Why you should attend: The guideline on "General Principals of Process Validation" was issued in May, 1987, and since then, medical device companies have struggled with process validation. Regulators believe through careful design and validation of the process, a manufacturer can establish a high degree of confidence that all manufactured units from successive lots will be acceptable. Successfully validating a process reduces the dependence upon in-process and finished device testing. Routine finished device testing is often insufficient to assure product quality. In some cases, destructive testing is required to show that the manufacturing process is adequate. End-product testing may not reveal product variations that can occur which may impact safety and effectiveness.
Areas Covered In the Seminar:
* What is Validation?
* When should it be used?
* How does it differ from verification?
* Validation vs. Verification: Which One?
* Protocol preparation
* Different types of validation
* IQ, OQ, and PQ
Who will benefit: This webinar is targeted toward professionals involved in meeting FDA's Quality System Validation requirements:
* Validation Specialists/Managers
* Process Engineers
* Manufacturing Engineers
* Quality Engineers
* Product/Process Development personnel
* Research and Development personnel
* Quality/Regulatory Personnel
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
