OOS Test Results and Completing [Robust] Investigations

Event

Online

£ 118.64 VAT inc.

*Indicative price

Original amount in USD:

$ 150

Description

  • Type

    Event

  • Level

    Advanced

  • Methodology

    Online

  • Class hours

    2h

  • Duration

    1 Day

  • Start date

    April
    other dates

  • Virtual classes

    Yes

Healthcare, Education, training

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

Online

Start date

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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

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

Overview:This training program will describe when a full investigation should be triggered and the frequency for re-testing and re-sampling. Attendees will also learn how to implement corrective and preventive action plans (CAPA).
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

https://www.compliance4all.com/control/w_product/~product_id=502162LIVE?channel=emagister_Nov_2018_SEO

OOS Test Results and Completing [Robust] Investigations

£ 118.64 VAT inc.

*Indicative price

Original amount in USD:

$ 150