Wed, 01/20/2016 – 4:00pmby Morf Media Inc.
Pharmaceutical, biotech and medical device manufacturers recognize that regulatory inspection is a normal part of their business. Yet many companies are unprepared or do not know the best practices for writing effective standard operating procedures, managing an inspection or responding to citations or other critical action by the agencies. Traditional compliance training often requires professionals to interrupt their workflow or attend a seminar offsite, adding cost, complexity and increasing the burden of adding another mandatory process to an already challenged workload. But organizations can now address this challenge by using secure, validated cloud technology and mobile technology.
XOOLI FDA Compliance Training offers managers a simpler, better way to control, enhance and report on compliance through compliance training. Managers can create multi-year training plans aimed at increasing training frequency and the use of tracking metrics that enable executive management to measure the level of compliance of their employees. This can be reported to executive management on a quarterly basis and corrective and preventive action needs to be taken when the results do not meet expectations.
XOOLI 2016 FDA Compliance Training offers a growing series of online courses available for use on mobile devices and PCs. The interactive courses with quizzes and exams written by FDA training experts, provide secure, yet fast and focused guides and the ‘Golden-Rules’ on preparing for, hosting and managing FDA Inspections, responding to FDA 483’s, CAPA training and more. The courses offer certificates of completion that can be used for continuing education credits.
The FDA Compliance Training series includes online courses on the following:
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 – 21CFR11 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 CRF 11 & CSV
Writing Effective SOPs
Key Factors for an FDA Inspection
XOOLI is a complete system for authoring, delivering certified courses, measuring an individual’s progress, and rewarding achievement. With its patented technologies for use on mobile devices, XOOLI takes into account the employees’ motivations, interests and strengths, empowering them to realize their full potential through an inspiring gamification platform built in collaboration with Yu-Kai Chou, the leading gamification expert in the world.
For more information, visit www.morflearning.com