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Compounding Pharmacy - Key Concepts in Microbiological Quality Control

Feb 07, 2020
Bethesda, MD

  • Education
  • The Americas
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Overview

Many of the regulations for compounding pharmacies have changed over recent years, with resulting requirements looking more like those applied to pharmaceutical manufacturing. As expectations have evolved so quickly for compounders, there has been a concordant need to quickly learn about new expectations and be prepared to put those into place for day-to-day practice. This training course will help close the knowledge gap about how compounders should be performing their microbiological QC testing, as well as control measures that should be implemented to contribute toward sterility assurance of products.

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

PDA Compounding Training Course Series

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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

Erin Patton
Erin Patton
Charles River
Bio
Erin Patton
Charles River

Erin Patton is the Senior Technology and Market Development Manager for Charles River Microbial Solutions, North America. Erin received her Bachelor of Science degree in Biology from Xavier University and her Master of Science degree in Cell and Molecular Biology from the University of Illinois, Urbana-Champaign. Erin has over 16 years’ experience in molecular biology research, microbiology QC, Quality Assurance, regulatory compliance, and compounding pharmacy. Drawing heavily on her background in molecular biology and her experience in sterility testing, Erin provides innovative rapid micro solutions for microbial detection and identification, and environmental monitoring programs. She is currently based in St. Louis, Missouri, USA and serves as a board member of the Missouri Valley chapter of PDA.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Explain the importance of testing in the overall quality program in the compounding facility
    2. Assess when and what to test when considering microbiological quality of product
    3. Evaluate appropriate methods and equipment to use in microbiological QC testing
    4. Review and interpret micro QC results to examine whether the compounded product is safe and the compounding process and facility is performing as expected
    5. Examine current regulations and how they should be appropriately applied in different compounding settings
  • Who Should Attend

    Who Should Attend

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

    Departments
    Quality Control, Quality Assurance, Quality Systems, Technical Operations, Training

    Roles
    Pharmacist, Auditor, Analyst, Microbiologist, Virologist, Supervisor, Manager

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs: 608 / 0116-0000-19-030-L04-P / 0.6
    Type of Activity: Knowledge

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is 6 CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is 6 PDH credits.

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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 $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 Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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SUBSTITUTION: If a substitution request is sent by Jan 04, 2020, no fee will be charged. After Jan 04, 2020, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Jan 04, 2020, a full refund will be given minus a $200 fee. After Jan 04, 2020, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Tel: +49 (0) 30 43 655 08-10

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