“A strong CAPA program helps managers and their staff quickly identify and address deficiencies, while pinpointing the sources of potential problems and preventing them,” said Angela Bazigos, FDA expert and Morf Media chief compliance officer.
San Francisco, CA (PRWEB) February 18, 2016
Morf Media Inc., shaping the future of enterprise talent development with compliance training, today announced a new FDA compliance training course, Corrective and Preventive Action (CAPA), on Morf Playbook™. The RAPS (Regulatory Affairs Professional Society) accredited course on Morf Playbook—now conveniently available on smartphones and PCs-provides a clear, effective approach to correcting and preventing problems, addressing customer complaints and fixing other nonconformities that can exist anywhere in a company.
The Root of the Matter
Analysis of Food and Drug Administration (FDA) and other investigation reports reveal that human error is named as one of the top root causes for deviations, discrepancies and quality incidents in pharmaceutical manufacturing. Managers may then feel compelled to rewrite standard operating procedures and retrain staff. But when the issue repeatedly resurfaces, deeper investigation shows that the CAPA is probably ineffective. Namely, the investigation has not yet pinpointed the root cause of the problem or its contributing factors to the problem. An effective CAPA should be developed to solve the problems with the system, facility and operation rather than focus on remediation of people.
“A strong CAPA program helps managers and their staff quickly identify and address deficiencies, while pinpointing the sources of potential problems and preventing them,” said Angela Bazigos, FDA expert and Morf Media chief compliance officer. “We’ve created an easy, fast and engaging interactive course on Morf Playbook to help managers enhance their company’s continual improvement efforts and strive to achieve operational excellence both in product and process.”
The interactive course, Corrective and Preventive Action (CAPA), allows managers to relate CAPA with Good Manufacturing Practices (GMP). It focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence. It shows managers how CAPA is integral to their overall quality management system (QMS). The new course on the secure Morf Playbook platform provides clear guidance to managers and helps them deliver best practices to their teams.
Topics covered in the Corrective and Preventive Action course on the Morf Playbook system include the following:
- Determining ownership
- Defining the problem
- Isolating and containing the problem
- Determining the root cause
- Choosing a corrective action
- Implementing and validating the corrective action
- Preventing Recurrence
- Preventive Action process
“This course shows that most often "human error" is not really the problem but a symptom of a system or facility or operation that is not designed to be run by humans,” added Bazigos. “Humans do contribute to problems but more often than not, because what we are asking them to do is not designed with humans in mind. So a true CAPA should be developed to solve the problems with the system, facility and operation rather than focus on remediation of people. This requires investigations to focus on getting to the real root cause and contributing factors.”
Morf Playbook provides a growing list of courses for 2016 FDA Compliance Training Series with certificates of completion for use toward continuing education units. The new courses include the following topics:
21 CFR Part 11
Cosmetics - How Are They Regulated
Drug Discovery and Development - The FDA Way
Writing Effective SOPs
Excel Spreadsheet Validation for 21 CFR 11
FDA Direct: Establishment Registration and Listing
FDA Direct: Overview of Regulatory Requirements for Medical Devices
FDA Direct: Risk Management & Drug Surveillance
FDA Inspection - Key Factors for a Successful Inspection
FDA Inspections – 21 CFR 11 and Computer System Validation
FDA Inspections - Food Facility Inspections
FDA Inspections - Information Readiness
FDA Inspections - Managing Inspection Outcomes
FDA Inspections - Managing Regulatory Risk
FDA Inspections - Organization Readiness
FDA Inspections - Program Overview
FDA Inspections - Quality System Readiness
FDA Quality Metrics – Latest Advances
Good Clinical Practices
2016 HIPAA Best Practices
Project Management for 21 CFR 11 & CSV
Key Factors for an FDA Inspection
European Data Protection Reform
The courses are individually available and are also available with the complete Morf Playbook training system. With its built-in authoring, reporting tools and analytics to measure an individual’s progress, Morf Playbook provides a secure platform with personalized recommendations for remediation, tracks course progress and completion, exam proficiency and provides certificates of achievement.
For more information about Morf Playbook courses and Morf Playbook platform, visit Morf Media.com or contact Natalia Glatcovschi at natalia(at)morfmedia(dot)com.
About Morf Media, Inc.
Morf Media, Inc. is shaping the future of enterprise talent development and compliance training with Morf Playbook™. The mobile platform provides one-to-one leadership, development, skill building and training on a smart phone, tablet or PC. Morf Playbook delivers interactive courses using a variety of media, including audiobooks and video. Its patented mobile framework offers an engaging way to empower people to perform at their best while providing individuals, team leaders and managers with reporting, metrics and communication tools to optimize talent and performance. Founded in 2013 by a seasoned management team, the company is based in San Francisco with offices in the Silicon Valley. For more information about Morf Media, please visit: http://www.morfmedia.com
Vice President Marketing of Morf Media, Inc. USA