“The Morf Playbook course goes into great depth to illustrate the expectations of the FDA in regards to 510k submissions."
San Francisco, CA (PRWEB) March 22, 2016
Morf Media Inc., developer of Morf Playbook™ talent development, skill-building and compliance training platform for use on mobile devices and PCs, today released a new interactive course that explores the FDA Refuse to Accept Policy.
Morf Playbook provides training on best practices with a risk-based approach to regulatory personnel at companies that must file a 510(k) Premarket Notification to receive FDA "approval" to market medium-risk medical devices.
“By instituting a Refuse to Accept Policy, the Center for Devices and Radiological Health will be able to focus substantive review only on submissions that are complete,” said Angela Bazigos, chief compliance officer at Morf Media Inc. “The Morf Playbook course goes into great depth to illustrate the expectations of the FDA in regards to 510k submissions. By following the outlined principles, you can minimize risk of submission rejection and increase the potential for a speedy review and approval by the agency.”
Topics Covered in the Morf Playbook course include the following:
- A complete overview of the FDA’s guidance on Refuse to Accept
- Best practices for pre-submission interaction
- A primer on the 510(K) Refuse to Accept Policies and Procedures, including;
- The 510(K) Checklist
- The FDA review Clock
- What to expect in a notification of acceptance
- The Acceptance Review Checklist
- Clear understanding of Traditional vs. Non-Traditional 510(K)s
The training on Morf Playbook provides step-by-step guidance on how to build a reliable strategy for delivering high-quality products at a profit with consistent operation of all systems. The course provides skill-building and leadership training for regulated industry professionals with Regulatory Affairs Professionals Society (RAPS) credit. Available now for use on smartphones, Morf Playbook provides the world’s premier playbook for compliance training enhanced with challenges, game theory and social feedback capabilities.
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
HIPAA Best Practices
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 - 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
Good Documentation 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 complete secure training delivery platform. It provides personalized recommendations for remediation, course progress and completion tracking, exam proficiency and 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, Morf Media, Inc. USA