Course Description

This web seminar will describe the basics of chemistry, manufacturing and control requirements for pharmaceutical (new drug) development. Participants will gain comprehensive understanding of regulatory expectations and industry best practices essential for successful drug development and commercialization. The course covers key regulatory pathways, documentation requirements, and quality assurance principles that ensure pharmaceutical products meet safety, efficacy, and quality standards throughout their lifecycle.

Learning Objectives

• Identify critical components to include in the CMC section of the FDA investigational and new drug applications
• Differentiate conformities and non-conformities to product specifications during manufacturing
• Find appropriate FDA guidance documents about CMC and GMP compliance

Who Should Attend

• Entry-Level Pharmaceutical Chemists
• Entry-Level Regulatory Professionals who have 0-5 years of regulatory experience and are looking to learn the “next level” of regulatory, beyond submission preparation
• Drug or Combination Product (drug/device) Team Members who would like to learn more about pharmaceutical regulatory requirements for chemistry, manufacturing and control details during pharmaceutical development

Instructor

Joy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.P.S, F.R.A.C.P.

Click here for complete trainer biographies

Registration Fees

$835*

*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1 hours (0.1 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-25-053-L99-P. Released: 8/25. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.