OOS Test Results and Completing [Robust] Investigations
Event
Online
*Indicative price
Original amount in USD:
$ 150
Description
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Type
Event
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Level
Advanced
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Methodology
Online
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Class hours
2h
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Duration
1 Day
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Start date
April
other dates -
Virtual classes
Yes
How the 21st Century Cures Act will impact the current pharmaceutical and medical device industries, particularly their processes for new product and new product indication requests.
Facilities
Location
Start date
Start date
Reviews
Subjects
- Quality
- Quality Training
- Education and training
- Online Courses
- Medical Education
- Compliance Trainings
- Healthcare programs
- Financial Education
- Audit function
- Compliance Validation
Teachers and trainers (1)
Adam Fleming
Event Manager
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements.
Course programme
Why should you Attend:This 90-minute accredited course is designed to provide sound training on how to recognize and investigate atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.
Areas Covered in the Session:Developing a Proper CAPA Plan to Address Any Corrective ActionsHow to Properly Document FindingsExample of a Proper OOS Investigation Write Up
Who Will Benefit:Lab AnalystsSupervisors and Managers in Pharmaceutical or Biological LaboratoriesRegulatory AffairsGMP AuditorsConsultantsTraining Departments
Speaker Profile: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. Prior to this role, Danielle has been in the industry for 17 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.com
Additional information
OOS Test Results and Completing [Robust] Investigations
*Indicative price
Original amount in USD:
$ 150