“We created this new Morf Playbook course to provide the context, the impact and the best practices related to the FDA’s 2012 legislation on medical device registration and listing,” said Angela Bazigos, chief compliance officer at Morf Media Inc.
San Francisco, CA (PRWEB) March 30, 2016
Morf Media Inc., developer of Morf Playbook™ enterprise talent development, skill-building and compliance training platform, today released a new course on mobile devices on Medical Device Establishment Registration and Listing for FDA Regulated Companies. The course is essential for owners or operators of places of business that are involved in the production and distribution of medical devices intended for use in the United States (U.S.). The course provides guidance for companies that are required to register annually with the FDA, a process known as establishment registration.
“We created this new Morf Playbook course to provide the context, the impact and the best practices related to the FDA’s 2012 legislation on medical device registration and listing,” said Angela Bazigos, chief compliance officer at Morf Media Inc. “An effective way to accomplish training on the go for use on a smartphone, this interactive course is designed to aid managers and quality control personnel in the formation of new expectations and streamlined processes, based on information directly from the FDA.”
Topics covered in the Morf Playbook course include the following:
- A primer on regulatory requirements
- The full list of who is required to follow medical device registration and listing requirements and what exemptions may exist
- Specifics on when to register and list
- An overview of registration and listing information
- Complete FDA Unified Registration and Listing System (FURLS) information, including;
- FURLS Accounts and Passwords
- Owner Operator Account
- Official Correspondent Account
- Creating Multiple Accounts
- A list of User Fees
- Step-by-step instructions on how to follow regulations
The training on Morf Playbook provides step-by-step guidance on how to expertly formulate registration and listing procedures that provide speed, improve overall product processes, reduce negative FDA reactions, and help build a positive reputation. Utilizing a risk-based approach, the Morf Playbook course provides context for the FDA’s 2012 legislation for medical devices and how to implement best practices based on those revisions. The training helps ensure strategy for delivering high-quality products at a profit with consistent operation of all systems. It provides skill-building and leadership training for regulated industry professionals with RAPS credit.
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 Morf Playbook courses are individually available and are also available with the complete Morf Playbook training system. With its built-in authoring and gamification, reporting tools and analytics to measure an individual’s progress, Morf Playbook provides a secure training delivery platform that's easy, fast and effective. 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
Morf Media Inc. Sector Specialist, Life Sciences and Healthcare
Vice President Marketing of Morf Media, Inc. USA