21 CFR 11 WITH XOOLI
Good Clinical Practice for FDA Regulated Companies from Morf Media, USA
Now on Mobile Devices
At its core, Good Clinical Practice is a set of broad regulatory requirements, standards, and recommendations that apply to thousands of highly specific tasks, processes, and roles in the conduct of clinical research. A large portion of the practical standards used in the conduct of clinical trials are “best practices” derived from interpretation of regulations and common sense.
Given the disparity between the detailed nature of clinical trial processes and tasks and the general GCP requirements and standards under which they occur, it is not surprising that interpreting and implementing GCP standards continues to represent challenges for the pharmaceutical, biotechnology, and medical device industries.
WHAT YOU WILL LEARN
This course will train you in all important aspects of Good Clinical Practice, including how to implement GCP to achieve clinical trial best practices, best patient safety and successful FDA and international regulatory authority inspections.
BASIC & INTERMEDIATE
- The full definition of Good Clinical Practice (GCP)
- An outline of the goals of GCP
- A comprehensive historical perspective on GCP
- An overview of FDA regulations relating to GCP in medical device research
- How to implement GCP
- How to prepare for FDA inspections of GCP
- A clear understanding of how FDA GCP compliance relates to international regulations
- Regulatory Affairs
- Quality Assurance
- Regulatory Authority Inspectors
- Clinical Safety Personnel
- Clinical Data Management Personnel
- IT personnel working on Clinical Systems
“Our quality managers enjoyed using XOOLI and I appreciated how time and resource effective it is to offer mobile training to my staff.”
Comprehensive training in Good Clinical Practice provides insight, improves research and trial processes, and reduces negative agency actions.
Delivers expert training in how to distinguish between best practices and legitimate FDA compliance procedures.
Clear, step-by-step guidance helps ensure strategy for delivering high-quality products at a profit with consistent operation of all systems.
Provides skill-building and leadership training for regulated industry professionals with RAPS credit — available now on Mobile Devices.
Utilizes an easy, fast and engaging approach to learning using challenges, game theory and social feedback capabilities.
XOOLI is the World’s Easiest to Use Mobile & Social Enterprise Talent Development Platform
Course Author Bio
Ms. Angela Bazigos
Chief Compliance Officer and Head of Life Sciences
Honored by Stanford Who’s Who for contributions to the Life Sciences Industry, Angela has more than 40 years of experience working with life sciences and healthcare organizations around the world. She is a Past President of PRCSQA, a member of the SQA, CVIC, ASQ, DIA and RAPS. She co-authored Computerized Systems in Clinical Research/Current Data Quality and Data Integrity Concepts with FDA and is a frequent contributor to international and industry publications. Ms. Bazigos was recently quoted in the Wall Street Journal on Using Training to Bring Compliance to the Boardroom. Ms. Bazigos additionally served as CCO for Prime Genomics, and held executive roles at Incyte Genomics, Roche and Counsyl among others.