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Technical Report No. 13: Fundamentals of an Environmental Monitoring Program

Apr 02, 2020
Raleigh, NC

  • Education
  • The Americas

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Overview

Environmental Monitoring is a tool utilized to evaluate the effectiveness of the contamination control strategy in the aseptic and surrounding manufacturing environment. Equipment and tools to assess the clean room and other controlled environments of a pharmaceutical facility serves, in parallel, to the sterility assurance program for the microbial quality of drug products and drug substances. The ideology addressed in this training course include regulations, current methodologies, equipment, identification, disinfection and cleaning, monitoring frequency and alert/action levels.

This training course will include interactive discussion on current methods, best practices, and rapid methods. It will focus on utilizing monitoring to identify gaps in the contamination control strategy in order to improve the quality of the aseptic environment, support investigations and satisfy the global regulatory expectations from a risk-based viewpoint.

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

PDA Environmental Monitoring Training Course Series
PDA Annual Training Course Series

Agenda

  • An agenda will be available soon. Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.

Trainers

Marc Glogovsky
Marc Glogovsky
Valsource LLC

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Apply current regulatory guidance to your environmental monitoring program
    2. Implement improved environmental monitoring procedures utilizing current methodologies and innovations
    3. Identify, select and apply appropriate monitoring methods to support your monitoring program
    4. Utilize trending to establish appropriate alert limits in your monitoring program
    5. Utilize identification data to support the contamination control strategy and aid in appropriate CAPAs for microbiology deviations/investigations
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved in design and execution of an environmental monitoring program in sterile drug manufacturing.

    Departments
    Manufacturing, Quality Assurance, Quality Control, Validation

    Roles
    Analyst, Manager, Specialist, Supervisor, Technician

  • 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: 102-1 / 0116-0000-19-038-L04-P / 0.6
    Type of Activity: Application

    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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500 South Salisbury Street
Raleigh, NC

How to Get Here

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Directions

Registration Fees

Early Registration
Registration Type Price By February 17, 2020
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $979






Regular Registration
Registration Type Price After February 17, 2020
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 Mar 03, 2020, no fee will be charged. After Mar 03, 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 Mar 03, 2020, a full refund will be given minus a $200 fee. After Mar 03, 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: +1 (301) 656-5900
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