loader
 

“Live Review” During Inspections – Is your team prepared?

Loading Events

During this session we will introduce the “Live Review” inspection technique and discuss its use in recent inspections.  Along with this technique comes several challenges, including preparing your System Owners, Subject Matter Experts (SMEs) and Inspection Staff.  This session will offer suggestions on how to best prepare your teams, including a review of Warning Letters, a Case Study, and a walkthrough of several “Live Review” questions.  “Live Review” most frequently focuses on Data Integrity, and understanding your Data Flows are key to successfully answering these types of questions.  Participants will gain access to a pool of questions they can take back to their areas to start the training process and gain alignment between Data Integrity expectations and their Data Flows.  This webinar is intended for Management, Training Staff, Inspection Staff, System Owners, SMEs, and anyone else expected to present their process or area to Inspectors.

 

  • Attendees will gain awareness of the following:
    • Evolution of inspection styles
    • Inspector Live Review techniques
    • Increased inspection focus on Data Integrity
    • Handling Live Review requests
    • Preparing your team for Live Review
    • Importance of understanding Data Flow
    • Including Live Review in Inspection Prep Training
  • Attendees will take with them:
    • Pool of Live Review Questions
    • Learning from Case Studies
    • Training Best Practices

 

Click Here to Register

 

 

Speakers

Camilla Perrotta-Fowler

Quality Compliance Sr. Specialist, Bayer U.S. LLC

Camilla is an experienced quality professional with 16 years of GMP regulated environment experience within the biotech industry, including: Product Release, Training, Complaints/Deviation Investigation, Quality Audit (Internal and External), Quality Risk Management/Facilitation, and Data Integrity. By leveraging regulatory requirements and industry expectations, Camilla’s current focus is on creating and delivering training content covering cGMP Compliance, Data Integrity, and Regulatory Intelligence.