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2020 BioMan

Environmental Monitoring and Contamination Control

Sep 24 - Sep 25, 2020
Dublin, Ireland

This course will provide a detailed review on how to establish and maintain an effective risk based EM Program for sterile/aseptic processing, non-sterile manufacturing, cell and gene therapy manufacturing and medical device manufacturing.

  • Education
  • Europe

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Program Highlights


Establishing a comprehensive microbial control strategy for your company is a key component of contamination control and an expectation of regulatory agencies. This fact is highlighted in the revised version of Annex 1. Contamination control for sterile, non-sterile, low-bioburden and cell and gene therapy manufactured products will all be included in this course with discussions around the differences in each area.

This two-day training course will be a complete review of all aspects of a contamination control program. A review of the regulation and requirements will be performed along with discussions around practical deployment of the requirements as well as challenges and solutions.

This interactive course will provide a detailed review on how to establish and maintain an effective risk based EM Program. Cleanroom classification, HVAC Qualification (EMPQ) and routine environmental monitoring requirements and best practices will be discussed along with establishment of cleaning/disinfection programs and disinfectant efficacy testing. EM alert/action level setting, EM excursion investigations and microbial identifications will be discussed.


  • Day 1
  • Day 2
  • Thursday , 24 September 2020

    Welcome & Introduction

    Guidance and Regulations

    • FDA Sterile Guidance
    • Annex 1 2008 and revised version
    • ISO 14644
    • USP/EP
    • PDA TR13 ‘Fundamentals of an Environmental Monitoring Program’

    Coffee Break

    Classification of Cleanrooms and EMPQ

    • ISO 14644-1 & 2
    • Selection of representative sample locations
    • Use of risk
    • Periodic classification
    • Baseline studies
    • Environmental Monitoring risk assessments
    • Static and Dynamic EMPQ

    Lunch Break

    Establishing Cleaning and Disinfection Programs

    • Selecting agents
    • Mopping
    • Rotations
    • Disinfectant Efficacy Studies

    Coffee Break

    EM Risk Assessment Methods

    • EM-REM
    • FMEA
    • HACCP

    End of Day 1

  • Friday, 25 September 2020

    Environmental Monitoring Equipment

    • Sampler types for viable and nonviable
    • Microbial ID EQ

    Environmental Monitoring (EM)

    • Non-viable particulates
    • Viable air and surface
    • Surface particulates
    • Personnel EM
    • Frequency of monitoring
    • Number of samples
    • Growth promotion of media
    • Establishing EM SOPs
    • In-house vs. CTO options
    • EMPQ

    Coffee Break

    EM for Different Manufacturing Processes

    • Sterile Products
    • Low Bioburden
    • Non-sterile
    • Cell and Gene Therapy

    Lunch Break

    EM Trending

    • Establishing alert and action levels
    • Meaningful trending and reporting
    • Use of EM Software

    EM Investigations

    • Conducting EM Investigations

    Coffee Break

    Microbial Identifications

    Summary, Q&A

    End of Course


Marsha L. Steed
Marsha L. Steed
bluebird bio

Additional Information

  • Learning Objectives

    Learning Objectives

    • Apply current regulatory guidance to your environmental monitoring program and contamination control strategies
    • Review and discuss the NEW contamination control requirements in the revised Annex 1
    • Understand the requirements of cleanroom classification and ongoing monitoring according to ISO 14644-1,2
    • Describe and discuss industry best practice and requirements for establishing cleaning and disinfection programs
    • Discuss disinfectant efficacy studies
    • Describe how to implement environmental monitoring risk assessments
    • Understand differences in EM requirements for non-sterile, low-bioburden, cell and gene therapy and sterile product manufacturing
    • Discuss how to create and perform EM performance qualifications (EMPQ)
    • Compare and contrast new and existing environmental monitoring equipment
    • Explain how to conduct EM investigations
    • Describe how to establish EM alert and action levels and how to prepare meaningful trend reports
    • Describe and review microbial identification instruments and methods
    • Understand how to establish the best microbial control strategy for your company
  • Who Should Attend

    Who Should Attend

    • Manufacturing - Supervisors/Managers/Specialists
    • Quality Control - Managers/Specialists/Technicians/Microbiologists
    • Quality Assurance - Managers/Specialists/Technicians/Microbiologists
    • Validation - Supervisors/Managers/Specialists/Technicians
    • Engineering - Supervisors/Managers/Specialists/Technicians

Got a Question? We have answers

Contact Us


PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Sheraton Munich Arabellapark Hotel

Northwood Park
Dublin, Ireland
Phone: +353 1 862 8888

Sheraton Munich Arabellapark Hotel
  • Accommodations

    Crowne Plaza Dublin Airport
    Northwood Park
    Santry Demesne
    Dublin 9

    The hotel is a 5-minute drive from Dublin Airport, with a free shuttle to and from the airport. It has luxurious rooms, free internet and good bus links to the city centre.
    Each bedroom has air conditioning, an on-demand movie system, a safe and ironing facility.Crowne Plaza Dublin Northwood is set in parkland, close to the M1 and M50, and 15 minutes from Dublin city centre.

    Northwood Crowne Plaza has a coffee bar, the Cinnabar Red Bar and a Californian-Asian restaurant, for a great variety of food and drinks. Breakfast starts early at 06:00. Crowne Plaza Northwood offers a park and fly facility and is on the airport bus route. Omni Shopping Centre, Swords Pavillions, Movie Plex and Northwood Business Campus are nearby. Croke Park Stadium is a short drive away.

    PDA Europe has reserved a limited number of rooms until the 24th July 2020
    Book your room for the PDA Group Rate

    • Single Superior Room € 159 per night*
    • Double Superior Room € 189 per night*

    *Rates are per room and night, including the following services and benefits free of charge:

    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service Charge will apply
  • Amenities

How to Get Here

By Air

Nearest Airport:

Dublin Airport - DUB
Airport Phone: +353 1 814 1111
9km , 10 min by car
Free Shuttle Bus fom and to the Hotels

By Car

The hotel is almost 10 km away from the Dublin Airport.

Other Options

More information coming soon.


Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT

* 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 30 days before the event, no fee will be charged. After this period, 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 30 days before the event, a full refund will be given minus a $200 fee. After this period, 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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