Using a risk driven approach, life sciences companies can get ready in advance of the FDA visit to address the key areas of concern including CAPA, risk management, vendor controls, and adverse event reporting during inspection.
San Francisco, CA (PRWEB) November 25, 2015
Impacting global manufacturers of medical devices and pharmaceuticals to biologics and biotech products, the U.S. Food and Drug Administration (FDA) continues to expand its powerful regulatory oversight. While international agencies often look to and adopt FDA guidelines, manufacturers around the world are seeking a better way to manage if not prepare for FDA investigation. Morf Media Inc. and World Compliance Seminars today announced they are delivering a simpler, better and more effective way for companies to get the FDA investigation training they need to perform at their best with a risk driven approach.
The comprehensive FDA Inspection Overview training course is available as a live seminar on December 3-4, 2015 in Boston and on February 4-5, 2016 in San Diego , online for mobile devices via Morf Media Inc. and coming in early 2016, on the Morf Training App for tablets and smartphones.
“Using a risk driven approach, we are helping life sciences companies get ready in advance of the visit to address the key areas of concern including corrective action or CAPA, risk management, vendor controls, and adverse event reporting during inspections,” said Angela Bazigos, CCO Morf Media Inc. “Together with our world-class partner, World Compliance Seminars, companies get the compliance training they need to understand what their regulatory risks are and to execute on plans to effectively address any gaps.”
While the course focuses on FDA inspections, inspections by other regulatory authorities such as European and Japanese regulatory authorities will be compared and contrasted to an FDA Inspection. The training is designed to provide proactive guidance to quality assurance regulatory affairs and validation auditors, risk managers, compliance officers and senior management. Bazigos presents best practices and tools to empower life sciences managers and executives to simplify management of the following:
- Assess quality system readiness for FDA inspection
- Identify compliance risks
- Mitigate before, during and after the inspection
- Follow up procedures to FDA Form 483, issued to at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
- Responses to warning letters
“The FDA inspection is one of the critical measures for success for your product and your organization as a whole,” added Bazigos. “This proven course will provide participants with the knowledge and the tools to build a solid foundation for passing FDA inspections from the perspective of the FDA inspector-valuable information to share with your teams that will benefit your company today and in the future.”
Online training for this course is available from Morf Media Inc. The company is developing its mobile training platform—Morf Playbook™ for companies of any size to offer cost-effective mobile compliance training to their staff and partners on their smartphone or tablets.
The FDA Investigation training course is among a library of certified courses that is delivered in an innovative way to support learning, engagement, measurement and achievement for professionals on the go. “We are building Morf Playbook to serve as the world’s easiest to use compliance training platform, made social, mobile, fast and fun,” said Roy Hanif, founder of Morf Media Inc. U.S.A. “With its mobile game-like three minute courses supported by a variety of media including text to voice and video for offline training, a framework of powerful analytics and reporting, life sciences companies and leading training companies, like World Compliance Seminars, are coming to us to provide training for the global mobile workforce anytime, anywhere.”
Morf Media offers a mobile training delivery platform with patented technologies that personalize learning, measure progress and reward achievement. For managers, the secure Morf Playbook software-as-a-service platform helps organizations streamline compliance training management, administration and reporting.
For more, please visit http://www.morfmedia.com
Twitter @morfmediainc #Morf2Compliance
About World Compliance Seminars, Inc.
WCS Consulting Inc. has the top industry experts and consultants in the country. Our onsite trainers and consultants are dedicated to providing you with the most useful and up-to-date information available at the most reasonable price. Our trainers and consultants will exceed your expectations by providing top quality training that will meet your training objectives. For more information, visit https://worldcomplianceseminars.com Contact us for Seminar Booking Toll Free 844-267-7299 support(at)worldcomplianceseminars(dot)com
About Morf Media, Inc.
Morf Media, Inc. is a social training delivery platform for the mobile workforce. For the first time a digital training system, Morf Playbook™ provides one to one training, anytime, anywhere, to millions on a smart phone or tablet. Serving as the world’s easiest to use training system, more than 100 companies and partners in the financial services and life sciences industries are choosing Morf Playbook with built in authoring, reporting, analytics and proof of examination certifications. Morf Playbook delivers interactive three minute courses via a variety of media including text to voice and video. Using Morf Playbook professionals can conveniently engage in training, reference policy details and get reminders and compliance notifications on the go. As a mobile platform-as-a-service, Morf Playbook offers secure centralized reporting for talent management and compliance training on a sustained basis.
Founded in 2013 by a seasoned management team, the company is based in San Francisco.
For more information about Morf Media, please visit: http://www.morfmedia.com
Vice President Marketing of Morf Media, Inc. USA