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GMPs for Compounders

Feb 07, 2020
Bethesda, MD

  • Education
  • The Americas


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. Typically, pharmacists do not receive extensive academic training in compounding operations and the FDA requirements governing compounding, and why these requirements exist. These requirements are intended to ensure that compounded products are safe and effective. There have been numerous inspections of compounding operations which have resulted in adverse regulatory findings (FDA-483 observations and Warning Letters). A number of recalls of compounded drug products have occurred, often due to lack of assurance of sterility.

This 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


  • Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.


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

Additional Information

  • Learning Objectives

    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. Illustrate how the FDA requirements help ensure compounded drug products which are safe and effective
    4. Recognize how poor compounding practices can impact the quality of compounded drug products
    5. 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.

    Engineering, Manufacturing, Pharmacy, Quality Assurance, Quality Control, Quality Systems, Quality Compliance, Regulatory Affairs

    Auditor, Director, Manager, Microbiologist, Operator, Pharmacist, Supervisor, Technician

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PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.


Registration Fees

Early Registration
Registration Type Price By December 20, 2019
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $979

Regular Registration
Registration Type Price After December 20, 2019
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $979

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].


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