Orphan Drug Development History & Overview

Joy L. McElroy

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This program will provide foundational knowledge of orphan drug development, including the history, leading to today’s standards and requirements. You will get an overview of current regulatory and legal requirements. This basis will serve to advance understanding of your role in the drug development process.

Why Should You Attend:

During discovery, thousands of compounds may be potential candidates for development as a medical treatment. After early testing, however, only a small number of compounds will go on to further study.

Before achieving approval, a myriad of research must be conducted.

This program will provide history of the drug development, process evolution and, review the stages of development, including the critical elements of each stage.

Areas Covered in the Webinar:

  • Orphan drug development
  • FDA Review and Approval
  • Generic Drug
  • Phases of Development
  • History

Who Will Benefit:

  • Pharma industry
  • Assistant
  • Associate
  • Manager
  • Anyone needing a full overview of the processes outside their functional area
  • Anyone desiring to enter a career in the pharmaceutical industry
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Joy L. McElroy,

Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt. With 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing. In 2013 Joy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.

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