Investigation of Out-of-Specification Test Results
Instructor:
Paul Larocque
Product ID: 706638
Training Level: Basic to Intermediate
- Duration: 90 Min
Why Should You Attend:
Attendees will learn how to streamline and conduct timely OOS and OOT investigations that meet FDA GMP expectations.
- Responsibility of the Analyst
- Responsibility of the Supervisor
- Obvious error
- Retesting
- Resampling
- Result validation
- Initiation of a production investigation.
- Invalidation of the initial result and accept the retest result.
Areas Covered in the Webinar:
- What does FDA say?
- Retesting: testing into compliance.
- Resampling: when can it be done; when not.
- Averaging: do’s and don’ts
- Outlier Tests: when they can be used; when they cannot
- Out-of-Trend: what is out of trend? Statistics.
Who Will Benefit:
Drug and biologic personnel working in production, R&D, regulatory affairs, QA, and QC.
Instructor Profile:
Paul Larocque
President, Acerna Inc
Paul Larocque is the President of Acerna Inc., a pharmaceutical, biological, and medical device consultancy, which provides good manufacturing practice and regulatory affairs services to a global clientele. For the past years consulting, and previously in industry, Paul’s focus was FDA compliance matters.
Previously, Paul held executive positions with Pfizer, Allergan, and Teva Pharmaceuticals, all related to sterile products. He was also head of the unit responsible for the review of the chemistry and manufacturing parts of drug submissions at Health Canada. He also chaired the industry committee that negotiated the sterile products chapter of the GMP regulations at Health Canada. He has provided expert sworn testimony in various legal cases.
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Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
