PHARMA/BIOTECH/MEDICAL DEVICES WITH XOOLI
Corrective and Preventive Action for FDA Regulated Companies from XOOLI
Now on Mobile Devices
A better CAPA should be developed to solve problems within the system, facility and operation rather than focusing on the remediation of individuals.
WHAT YOU WILL LEARN
This course will equip you with a clear and effective approach to correcting and preventing operational problems, customer issues, and other non-conformities that can negatively affect your company.
This course helps managers relate CAPA with Good Manufacturing Practices (GMP) and focuses on the systematic investigation of discrepancies within operations in an attempt to prevent recurrence.
BASIC & INTERMEDIATE
- A primer on why human error is the automatic designation behind deviations and discrepancies
- How to determine the real root cause of ineffective CAPAs
- Specialized information on the real cause of ineffective processes
- How to successfully discover the true causes and contributing factors of system problems
- How to formulate a better CAPA to address true problems
- Quality Assurance Personnel
- Quality Control Personnel
- Supply Chain and Logistics Managers
- Regulatory Affairs Professionals • Process Development Scientists and Management
- Manufacturing Management and Scientists
- Project Managers working in the CMC arena
“Our quality managers enjoyed using XOOLI and I appreciated how time and resource effective it is to offer mobile training to my staff.”
Expertly formulated Corrective and Preventive Actions (CAPAs) provide correction, improve processes, reduce downtime, and improve work consistency.
Provides a clear approach to correcting and preventing problems, customer complaints and other nonconformities that can exist in a regulated organization.
Clear, step-by-step guidance helps ensure strategy for delivering high-quality products at a profit with consistent operation of all systems.
Provides skill-building and leadership training for regulated industry professionals with RAPs credit — available now on Mobile Devices.
Utilizes an easy, fast and engaging approach to learning using challenges, game theory and social feedback capabilities.
Course Author Bio
Ms. Angela Bazigos
Chief Compliance Officer and Head of Life Sciences
Honored by Stanford Who’s Who for contributions to the Life Sciences Industry, Angela has more than 40 years of experience working with life sciences and healthcare organizations around the world. She is a Past President of PRCSQA, a member of the SQA, CVIC, ASQ, DIA and RAPS. She co-authored Computerized Systems in Clinical Research/Current Data Quality and Data Integrity Concepts with FDA and is a frequent contributor to international and industry publications. Ms. Bazigos was recently quoted in the Wall Street Journal on Using Training to Bring Compliance to the Boardroom. Ms. Bazigos additionally served as CCO for Prime Genomics, and held executive roles at Incyte Genomics, Roche and Counsyl among others.