Winning Investigations & CAPA

Overview:

The webinar provides a brief overview of the high-level investigations and CAPA process, including key considerations for each. It includes an overview of risk assessments, and root cause analysis tools, and touches on do’s and don’ts for writing clear, concise, logical reports that do not require interpretation and withstand regulatory scrutiny.

Why you should Attend:

Many firms struggle with recurring or repeat deviations, documentation errors, and rework. This webinar provides an overview of a simple but effective high-level process, as well as a prevention mindset, that helps investigators hone in on true, underlying root cause and contributing factors, and design effective CAPA designed to fix the problem and prevent recurrence. This is the goal of all investigations. This webinar will help attendees view investigations through a prevention lens, and start to move the needle toward error reduction at their firms. 

Areas Covered in the Session:

• Regulatory requirements
• Investigation process overview
• Initiation
• Risk assessment
• Root cause analysis
• Prevention mindset
• CAPA
• Report writing

Who Will Benefit:

• Manufacturing Leads, Supervisors, Managers, Associate Directors, Directors, Investigators
• Quality Control Analytical and Microbiology Analysts, Scientists, Leads, Supervisors, Managers, Associate Directors, Directors
• QA and Quality Systems compliance, Specialists, Engineers, Validation, Supervisors, Managers, Associate Directors, Directors, Officers, Auditors
• Engineering/Facilities/Maintenance - Leads, Supervisors, Managers, Associate Directors, Directors.
• Supply Chain/Logistics/Warehouse - Supervisors, Managers, Associates, Leads, Directors
• Manufacturing Science & Technology / Process Development - Scientists, senior scientists, managers, directors, etc.
• Webinar Provides Good Foundational Knowledge for Operations Employees at all Levels
• Training and/or Learning & Development Managers, Associate Directors, Directors