Steven Laurenz, Principal Consultant – BioPhia Consulting Inc., has over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. He is skilled in taking new products from early laboratory stage to successful manufacturing launch. He is an expert in integrating Quality by Design and risk management into product development. He has proven experience in establishing a Quality System for a R&D Quality Assurance organization.
Steven has headed product development departments at Abbott Laboratories and AbbVie Inc. and held leadership positions in numerous technical consortium.
Steven Laurenz holds an M.S. in Chemical Engineering from the Michigan State University
Successfully Investigating Deviations
Product Id : FDB2161Category : Clinical & Laboratory, FDA Compliance, Food, Drugs & Biologics, Medical Devices
Presenter : Danielle DeLucy
Scheduled On : March 17 2022 1:00 pm
US/Canada (Eastern Time - ET)
Duration : 75 Minutes
Please follow the link to Register :
https://www.webinarcompliance.com/product/successfully-investigating-deviations/
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Learn how to identify and avoid potential pitfalls during deviation investigations.
Areas Covered in the Session :
Review of FDA and Regulatory Requirements for Investigations
What is the definition of a Deviation?
Types of Deviations/Identification of Deviations
Conducting the Investigation
Interviews – do’s and don’ts
Source Documents/Evidence
Determining Root Cause and Effective/Sustainable CAPA to avoid 483 observations
Key Elements of the Investigation Report
Who Will Benefit:
Deviation Investigators
Reviewers and Approvers of Deviation Investigations
Quality Assurance Departments
Regulatory Affairs Departments
Quality Control Departments
Compliance Auditors