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Compounding Pharmacy - Improving Aseptic Operations

Feb 03 - Feb 05, 2020
Bethesda, MD

  • Education
  • The Americas
Closed

Overview

Compliance issues with a significant number of compounding pharmacies make it vital for compounders to have the necessary tools to understand hazards to patients incurred during compounding. Most importantly, compounders need an understanding of aseptic operation. The key intent is to improve knowledge for better decision-making and skills in aseptic technique.

In this training course, you will improve your understanding of microbial control and prevention of cross contamination for better quality compounded preparations. You will gain skills in aseptic technique by participating in hands-on activities such as environmental monitoring, smoke studies, gowning, and aseptic filling of media. Topics will include current issues in compounding pharmacy, cleaning, sterilization and sanitization, and USP <797> and <800>.

Please note that this training course has hands-on lab activities. Please wear long pants and closed-toe shoes.

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

PDA Compounding Training Courses

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Agenda

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

Trainers

Christopher J. Smalley
Christopher J. Smalley
ValSource Inc.
Bio
Christopher J. Smalley
ValSource Inc.

Chris Smalley has retired from Merck, where he had responsibility for innovative implementation and validation, including Single Use Systems and Isolators globally. He now is a consultant for Valsource, focused primarily on Compounding Pharmacies. Previously, he had been Director of Quality Operations for Wyeth Pharmaceuticals for 12 years with responsibility for setting validation standards and validation activities globally. His research experience includes responsibility for Quality in the U.S. operations of the Sanofi Research Division, and earlier he had worked for the Johnson & Johnson family of companies, where he was a Plant Manager.

Chris retired after 21 years of service as a LtCol in the USAF. Chris practiced as a compounding pharmacist across the military hospital system, compounding intravenous solutions and total parenteral nutrition products. Chris is a graduate of the Philadelphia College of Pharmacy. His graduate education includes a MBA from TU Fox School of Business, a Masters of Science in Pharmaceutical Chemistry from TU School of Pharmacy, and a PhD in Healthcare Administration from LaSalle University.

Chris has been a member of the PDA Board of Directors, the PDA Science Advisory Board, and is a member of the ISPE Disposables CoP Steering Committee and the Pharmaceutical Engineering Committee.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Demonstrate how to achieve and maintain environmental control
    2. Demonstrate how to achieve sterilization and differentiate from sanitization
    3. Examine use and limitations of unidirectional HEPA filtered air
    4. Explain cleaning and the role of materials of construction
    5. Interpret the revised USP <797> and <800>
  • Who Should Attend

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

    Departments
    Quality Control, Pharmacy

    Roles
    Supervisor, Analyst, Microbiologist, Pharmacist, Technician

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Travel

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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.

Directions

Registration Fees

Early Registration
Registration Type Price By December 20, 2019
Member $3,419
Non-member $4,103
Gov't/Health Auth./Academic* $2,659








Regular Registration
Registration Type Price After December 20, 2019
Member $3,799
Non-member $4,559
Gov't/Health Auth./Academic* $2,659








* 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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