Faculty: Joy McElroy ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB3571


  • Date: 2/6/2023 11:00 AM - 2/6/2023 12:00 PM
  • Location: Online Event

Tickets


Ticket Type
Qty
Live- Single
$250.00
0
For ONE Participant – Live session only
Live Corporate
$750.00
0
For Maximum of 10 participants – Live session only
Recording - Single
$390.00
0
Recording access for ONE participant (viewer) – Unlimited viewing access for 6 months
Recording - Corporate
$1400.00
0
Recording access (Multiple licenses) for up to 10 participants – Unlimited viewing access for 6 months

Total

$0.00

Description

The FDA’s Center for Drug Evaluation and Research (CDER) is responsible for reviewing and approving both prescription and nonprescription or over-the-counter (OTC) drugs. To introduce a new drug product into the U.S. market, some firms submit a new drug application (NDA) to the US FDA/CDER. The firms are responsible for testing a drug and for submitting evidence that the drug is safe and effective.


This webinar is intended to help you better understand FDA’s drug review and approval process. The FDA’s recent approvals of novel drugs will also be discussed. The speaker will walk you through the regulatory requirements for FDA’s drug review and approvals.

Areas Covered in the Session :

  • Latest Laws and Regulations
  • Recent FDA Guidances and Definitions
  • Regulatory Requirements for New Drug Application (NDA) and Biologics License Application (BLA)
  • Drug Development
  • FDA Drug Review and Approval
  • Common Mistakes
  • Critical Considerations
  • Enforcement Actions
  • Recent FDA Approvals
  • Best Practices and Recommendations

Who Should Attend:

  • Quality Assurance Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Compliance Officers
  • Clinical Affairs Professionals
  • Consultants
  • Contractors/Subcontractors
  • Everyone Interested in the FDA Drug Review and Approval Processes

Course Director: Joy McElroy

 

Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the 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 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence.

Her knowledge, experience, have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing, and GMP, Audit Preparation, and SOP writing training, Computer System Validation and Part Compliance.

In 2019 she opened her own company, McElroy Training and Consultancy, LLC which provides consultants for various projects as well as on and off – site training to pharmaceutical and biotech companies throughout the United States.

Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams though implementing 5 simple techniques she has learned and applied through the years.