“SOPs Missing in Action” is Cited as a Top Cause for FDA Warning Letters According to Morf Media Inc. Chief Compliance Officer. Thousands of Professionals at Pharmaceutical, Biotech, Device and Food Manufacturing Organizations Have Benefited from the RAPs accredited course on Writing Effective SOPs
San Francisco, CA (PRWEB) February 04, 2016
Morf Media Inc., shaping the future of enterprise talent development and compliance training, today announced an interactive FDA compliance training course, Writing Effective SOPs (Standard Operating Procedures) on Morf Playbook™. The RAPS (Regulatory Affairs Professional Society) accredited interactive course on Morf Playbook—now conveniently available on smartphones and PCs–provides step by step direction on writing and maintaining effective SOPs.
Though SOPs are required by law for companies regulated by the Code of Federal Regulations such as Title 21, Title 42 and other international regulations, no guidance is offered by regulatory agencies on SOP best practices. Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible. Worse, this often leads to costly errors that first come to light during a regulatory inspection.
“SOPs Missing in Action or Badly Written SOPs” is one of the top causes that trigger an FDA 483 or warning letter,” said Angela Bazigos, chief compliance officer at Morf Media Inc. “An incomplete or difficult to follow SOP can lead to dangerous outcomes. Now, it’s easy to learn a better way to write and manage clear effective SOPs with this proven course on Morf Playbook.”
Thousands of professionals at pharmaceutical, biotech, device and food and beverage manufacturers, diagnostic laboratories and suppliers have benefited from the clear methodology of the course, designed to improve communication and work consistency while reducing costly training time and errors.
Areas covered in the interactive course on Writing Effective SOPs include the following:
- Overview of SOPs and their Relation to Regulations
- Value and Ethics: the Impact of SOPs as part of the Company’s
- Expert Insights on What the FDA (Food and Drug Administration) Looks for in SOPs During an Inspection
- Best Practices for Writing SOPs with a Risk Based Approach
- Hands-on Training on Writing SOPs to Ensure Conciseness, Efficiency and Ease of Use.
- Powerful yet Easy to Use Tools for SOP Life-cycle Tracking
- Clear Requirements for Validation activities for SOPs
The interactive course on Morf Playbook offers complete training with quizzes and exams written by FDA training experts. For those seeking continuing education credits, it offers a certificate of completion. Writing Effective SOPs on Morf Playbook meets multiple agency requirements around the world, such as FDA, ICH (International Conference on Harmonization) and Clinical Laboratory Improvement Amendments (CLIA) Requirements.
The Writing Effective SOPs course is among a growing list of interactive FDA Compliance Training courses now available on Morf Playbook. For a complete catalog of available courses, please visit the Morf Playbook FDA Compliance Series.
“Performing a role with clear SOPs helps build professional confidence and can help support a culture of ethics,” added Bazigos. “Our goal is to bring training that helps professionals perform at their best while contributing ever greater value to their organization and ultimately to patient safety and healthcare innovation.”
With its patented technologies for use on mobile devices, Morf Playbook takes into account an individual’s motivations, interests and strengths, empowering a professional to realize their full potential on a secure and easy to use platform.
For company managers and administrators, Morf Playbook offers a complete system for rapid authoring and delivering certified courses. Its built-in reporting tools and analytics measure an individual’s progress. The secure platform provides personalized recommendations for remediation, tracks completions and exam proficiency and hosts certificates of achievement.
Morf Playbook growing list of courses for accredited 2016 FDA Compliance Training Series on Morf Playbook offers the following list of essential courses with certificates of completion for use toward continuing education units.
21 CFR 11: Basic Concepts
Corrective and Preventive Action
Cosmetics – How Are They Regulated
Drug Discovery and Development – The FDA Way
European Data Protection Reform
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
For more information, visit Morf Media.com or contact Natalia Glatcovschi at natalia(at)morfmedia.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
For the original version on PRWeb visit: http://www.prweb.com/releases/2016/02/prweb13201177.htm