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Live eLearning - PDA 739 GMPs for Compounders

Jun 02, 2020
1:30 PM
4:00 PM
| Eastern Standard Time
  • Virtual
  • Education
  • Online


Pharmacy compounding has become an important means of providing specialized drug products for patients for whom commercially available drug products are not appropriate. Compounding operations may take place in an institutional setting (e.g., hospital, nursing home, etc.), a 503 A or B compounding pharmacy or a conventional pharmacy. Because compounded drug products have not undergone the FDA review and approval process, they have an increased potential to present a risk to the patients who take them.

This live, virtual training course will provide an overview of the FDA regulatory oversight process and will discuss FDA’s regulations and guidances which govern the compounding of drug products, especially in outsourcing (503B) operations. The training course will include a review and analysis of actual FDA citations found during inspections of compounding operations and will provide insights into how to avoid adverse regulatory findings and how to respond to them should they occur.

For more options and/or related training courses, please visit the page(s) below.

PDA Compounding Training Courses


Robert L. Dana
Robert L. Dana
Elkhorn Associates Inc.

Learning Objectives

  1. Describe FDA’s role and mission and how they accomplish it
  2. Explain FDA’s GMP requirements and the special requirements for compounded drug products
  3. Analyze FDA regulatory findings and prepare an action plan to respond to them

Who Should Attend

This training course is intended for professionals who are involved in compounding pharmacy.

  • Quality Control
  • Quality Systems
  • Quality Compliance
  • Manufacturing
  • Quality Assurance Operations
  • Technical Operations
  • Training

  • Specialist
  • Operator/Technician
  • Supervisor
  • Manager

Registration Fees

Registration Type Price
Member $100
Non-member $100
Gov't/Health Auth./Academic $100

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