Organize and Presented By
247compliance
Sponsored By
247compliance
Organizing/Related Departments
Medical Device
Organization Type
Event Organizing Company
WebinarCategory
Non Technical
WebinarLevel
All (State/Province/Region, National & International)
Related Industries
Medical/Healthcare/Hospital
Location
Newark, Delaware, United States
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using documents, interviews, and objective evidence to arrive at a root cause and a corrective and preventative action plan.Learn how to identify and classify deviations for easier management and investigation.
- Describe what types of deviations exist
- Explain how to conduct a proper investigation
- Learn new tools for proper root cause analysis
- What things to avoid during the investigation
- How to properly document and manage the deviation details
- How to close the deviation and assess impact to the final product.
FDA, EMA, and other international regulatory agencies require that there be a deviation investigation system as a subsystem of a company's overall quality system. Those involved in performing investigations, review and acceptance of non-conformance investigations, will learn how to conduct investigations, dos and don'ts in interviews, how to determine CAPA and more in this webinar.
- Review of regulatory requirements for investigations
- What is the definition of a Deviation?
- Types of Deviations/identification of Deviations
- Conducting the investigation
- Interviews - dos and don'ts
- Source Documents/Evidence
- Determining root cause and effective/sustainable CAPA
- Key elements of the investigation report
- Mid-Level Managers
- Compliance Officials
- Manufacturing Personnel
- Laboratory Personnel
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 15 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.
Others Details
For more detail please click on this below link:
http://bit.ly/2ksgHbO
Email: [email protected]
Tel: +1-(510)-868-1040
Registration Fees
Available
Registration Fees Details
Live session for 1 participant
$199
Live + Recorded Session
$269
Live + Transcript
$249
Live + Training CD
Free shipment within 72 hours from the date of webinar completion.
$450
On Demand Options
Transcript
$179
Downloadable recorded session
$239
Training CD
Free shipment within 72 Hours, from the date of webinar completion
$350
Group Session unlimited participants + Recorded
$799
Registration Ways
Email
Phone
Website
Other
Address/Venue
247compliance
2035 Sunset Lake,
RoadSuite B-2,
Newark,
Delaware - 247compliance
Pin/Zip Code : 247compliance