This Event has Passed
Tuesday, March 06, 2018
1:00 PM - 2:00 PM
1:00 PM - 2:00 PM See all dates and Times
http://bit.ly/2EIJSwO
OVERVIEW This webinar will review the regulatory requirements for investigating an OOS Investigation.The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
WHY SHOULD YOU ATTEND
The lack of or inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters.
AREAS COVERED
FDA requirements for handling OOS/ OOT results
Phase I- Laboratory Phase of Investigations
Phase II a Full Scale Investigation
Concluding an Investigation
Out-of Trend investigations
Common pitfalls during OOS Investigations
LEARNING OBJECTIVES
Learn the responsibilities of Analysts and Supervisors
Listen to what the FDA looks for in terms of Human Errors
Describe when a Full Investigation should be triggered
Describe the frequency for Re-testing and Re-sampling
WHO WILL BENEFIT
Quality Assurance/Quality Control Directors, Managers, and Specialists
Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists
Engineering/Development Directors, Managers, and Specialists
SPEAKER
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance.
For more details click on this link:
http://bit.ly/2EIJSwO
You may also refer to this link:
https://www.trainingdoyens.com/product/50167-product-quality-review
https://www.trainingdoyens.com/product/50103-data-integrity-&-cgmp-compliance
https://www.trainingdoyens.com/product/50159-failure-mode-and-effect-analysis
Ticket Price:
Live Webinar : $199
Recorded Webinar : $219
Training DVD or USB Flash Drive : $399
Super Combo Offer 1 : $329
Super Combo Offer 2 : $499
WHY SHOULD YOU ATTEND
The lack of or inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters.
AREAS COVERED
FDA requirements for handling OOS/ OOT results
Phase I- Laboratory Phase of Investigations
Phase II a Full Scale Investigation
Concluding an Investigation
Out-of Trend investigations
Common pitfalls during OOS Investigations
LEARNING OBJECTIVES
Learn the responsibilities of Analysts and Supervisors
Listen to what the FDA looks for in terms of Human Errors
Describe when a Full Investigation should be triggered
Describe the frequency for Re-testing and Re-sampling
WHO WILL BENEFIT
Quality Assurance/Quality Control Directors, Managers, and Specialists
Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists
Engineering/Development Directors, Managers, and Specialists
SPEAKER
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance.
For more details click on this link:
http://bit.ly/2EIJSwO
You may also refer to this link:
https://www.trainingdoyens.com/product/50167-product-quality-review
https://www.trainingdoyens.com/product/50103-data-integrity-&-cgmp-compliance
https://www.trainingdoyens.com/product/50159-failure-mode-and-effect-analysis
Ticket Price:
Live Webinar : $199
Recorded Webinar : $219
Training DVD or USB Flash Drive : $399
Super Combo Offer 1 : $329
Super Combo Offer 2 : $499
