Drug Discovery and Development for FDA Regulated Companies

PHARMA/BIOTECH/MEDICAL DEVICES WITH XOOLI

Drug Discovery and Development for FDA Regulated Companies from XOOLI
Now on Mobile Devices

PHARMA/BIOTECH/MEDICAL DEVICES WITH XOOLI

Drug Discovery and Development for FDA Regulated Companies from XOOLI
Now on Mobile Devices

Drug Discovery and Development processes are complex and require every participant to focus on his or her particular piece of the puzzle. It’s normal to spend a lifetime in one part of the process and never comprehend the complete picture. But training each participant in every part of the drug discovery and development process is key to keeping a company healthy and profitable.

WHAT YOU WILL LEARN

This course will clear any ambiguity or misinterpretation in any area of the FDA regulations on drug processes and will equip you with the latest developments in compliance.

“Our quality managers enjoyed using XOOLI and I appreciated how time and resource effective it is to offer mobile training to my staff.”

AVAILABLE LEVELS
BASIC & FUNDAMENTAL

TOPICS COVERED

  • An overview of the stages of drug development and review
  • Simplification of Drug Review Steps
  • A picture of the application review process
  • Complete overview of accelerated approval qualifications
  • A primer on possible setbacks in the process
  • The role of user fees
  • The quality of clinical trials
  • How drugs are approved
  • How the FDA differs from other regulatory authorities
  • Frequently Asked Questions about the FDA drug approval process
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PERFECT FOR

  • Workers and personnel in the Pharmaceutical, Biotechnology or Medical Device Industries
  • Workers and personnel in the above industries that are transferring into another part of the drug development process
  • Workers and personnel in support companies such as IRBs, CROs, and Data Monitoring Companies
  • International professionals unfamiliar with FDA processes

Expert training in drug discovery and development processes provides insight and improves interpersonal relationships.

Utilizing a risk-based approach, this course provides a comprehensive overview of the drug discovery and development process while taking into account FDA expectations and regulation.

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.