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Best Practices for Investigating Deviations and Non-Conformances

 
  August 26, 2019  
     
 
CfPA-The Center for Professional Advancement, Online Live
October 15, 2019 at 11:00 a.m.–12:30 p.m. (ET)


Who Should Attend?
This online training is intended for professionals in the Pharmaceutical, Biotech and other life-science industries. It will be especially valuable to:
  • Deviation investigators
  • Reviewers and approvers of deviation investigations 
  • QA staff and management
  • Regulatory Affairs staff and management
  • QC staff and management

Course Description
One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses the investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, release of sub-standard product, or product recall. Furthermore, costly and time-consuming system remediation may be required.

Having a procedure on Deviation Investigations is not enough. It is the content and conclusions of the investigations themselves that truly count. Doing a proper root cause analysis, gathering evidence and ensuring a sustainable corrective action is key to a proper deviation investigation. 

This 90 minute accredited course will help attendees understand the fundamental investigation steps and skill sets. Key focus will be placed on identification and initial reporting of deviations, fact/evidence gathering, and arriving at the correct root cause and CAPA. The importance of investigation planning, critical thinking skills and effective preventative action plans will also be discussed. 

Can't Make this LIVE Webinar? 
Simply select the On Demand option when registering and we will send you the link to view the recorded version.

On Demand available approximately 3 business days after the live offering.
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   Danielle DeLucy, MS; Owner, ASA Training & Quality Consulting LLC

Danielle DeLucy, MS, is currently the owner of ASA Training & Quality Consulting, LLC, an Independent Consultant Agency to the Biologics and Pharmaceutical Industries specializing in the areas of Quality Assurance and Quality Systems. Prior to this role, Ms. DeLucy has been in the industry for 18 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. Ms. DeLucy began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Ms. DeLucy assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.

 


 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
 
 
   
 
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