Excellent standards for documentation within a company can be critical in manufacturing quality products that are safe as well as successful during audit situations,” said Angela Bazigos, FDA training expert.
San Francisco, CA (PRWEB) February 29, 2016
Morf Media Inc., shaping the future of enterprise talent development with compliance training, today announced a new FDA compliance training course, Good Documentation Practices on Morf Playbook™. The RAPS (Regulatory Affairs Professional Society) accredited course on Morf Playbook—now conveniently available on smartphones and PCs - allows managers operating at companies in a Good Clinical, Laboratory and Manufacturing Practices (GxP) environment to meet requirements to ensure product quality and product safety.
Good documentation practices are integral to an organization’s overall Quality Management System (QMS). While not law, authorities will inspect against these guidelines in addition to the GxP requirements and make comments or observations if departures are seen.
The proven course provides clear guidance to quality control personnel, supply chain managers, regulatory affairs professionals, process design scientists and management and manufacturing management and scientists on how to formulate and deliver best documentation practices to their teams.
The new course on Morf Playbook allows professionals to provide expert records, streamline processes, reduce negative reviews and outcomes, and improve record consistency. It provides a clear approach to correcting and preventing documentation issues, regulating consistent practices and avoiding negative reviews from the FDA and other agencies. Training offers clear, step-by-step guidance that helps ensure strategy for delivering high-quality products at a profit with consistent operation of all systems.
“Excellent standards for documentation within a company can be critical in manufacturing quality products that are safe as well as successful during audit situations,” said Angela Bazigos, FDA expert and chief compliance officer at Morf Media Inc. “This course will show you how to meet industry standards of documentation by demonstrating how best to record information as it relates to good clinical laboratory and manufacturing processes (GxP).”
Topics covered in the course include the following:
- How to record and round numbers for statistical analysis
- How to be compliant when writing, recording or amending information for documentation used in Good Clinical, Laboratory and Manufacturing Practices (GxP)
- Comprehensive information to ensure records provide documented evidence, traceability and an audit trail that will warrant successful investigations
- How to make documents attributable, legible, contemporaneous, original and accurate.
- Compliance in amending documents or records
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 firstname.lastname@example.org.
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