Meeting The New ISO Cleanroom Standards And Changing EU Guidances - How Will You Comply?

March 02-03, 2017 | Montreal, Canada

Course Description:

The International Cleanroom Standards (ISO 14644-1 & 2) have been updated, these changes affect the requirements for the classification testing and monitoring of ALL cleanrooms. The classification testing standard has significant changes and includes the requirements for the development of a “Monitoring Plan” based upon risk assessment. How will you comply with these changes?

With changes to number of sampling sites, testing frequencies, particle classification limits and rules it is critical to re-visit your environmental monitoring program.

How will you address the differences between particulate limits for classification and monitoring as changed in the new ISO 14644 parts 1 & 2 and those of current EU Ennex1?

A risk based approach to environmental monitoring is emphasized in the new ISO standard and the current EU Annex 1. As the ISO standards are being updated, PICs supported by EMA is in the process of revising EU Annex 1 to align with ICH Q9 and Q10 risk based approach and current technologies. A risk based approach to sample site selection, considerations for monitoring technology, as well as other risk considerations during environmental monitoring will be discussed in this two day intensive training.

gallery 1

Ziva Abraham

President and Founder

Microrite, Inc.

Ziva Abraham is the President and Founder of Microrite, Inc., a California based consulting firm. She has over 25 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master’s Degree in microbiology with a focus on Mycology and has worked on developing microbial Insecticides using entomogenous bacteria and fungi for her doctoral research. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She has trained personnel from various industries in microbiology techniques and methods. She uses her extensive experience to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective.

gallery 1

Morgan Polen

Member of IEST’s US Technical Advisory Group to ISO/TC 209 Cleanrooms

Microrite, Inc.

Morgan Polen has been involved with cleanrooms and contamination control since 1984, working in over 40 countries involved with projects ranging from cleanroom design, construction, validation, monitoring program development, particle counter design and product management for cleanroom related products and systems. Addressing monitoring and control solutions in a wide variety of clean industries such as pharmaceutical, medical device, semiconductor, data storage, aerospace, defense, automotive, optical and others. Morgan is a member of IEST’s US Technical Advisory Group to ISO/TC 209 Cleanrooms and Associated Controlled Environments, participating in the process of adapting the latest cleanroom standards.

Day 1 Course Agenda & Contents
8:00 AM – 8:30 AM
Registration and continental breakfast
8:30 AM – 10:00 AM
Changes to ISO Standards-What does it mean to you?
  • Understanding the changes to ISO 14644 parts 1 and 2
  • How long do you have to comply with the new ISO Standard?
  • How will it affect you current EM program?
  • What has changed in the standard that may affect your current EM program?
  • Proposing shelf life based on the ICH Decision Tree and statistically estimated shelf life
10:00 AM - 10:15 AM
Mid-morning Refreshment Break
10:15 AM – 12:00 PM
Airflow Pattern analysis-Why do regulators expect this?
  • Role of Airflow visualization studies (smoke studies) in:
    • Confirming airflow parameters, direction and uniformity to mitigate contamination risk and assess and define critical control points
    • Assess airborne particles and microbial contamination risk to product
12:00 PM - 1:00 PM
Networking Lunch
1:00 PM - 2:00 PM
Methods of airflow pattern analysis-meet ICH Q9 and Q10 risk based approach
  • Benefits of performing airflow analysis during static and dynamic conditions
    • Simulation of interventions to assess and prevent risk during aseptic processing
  • Equipment considerations to visualize airflow from source to return
  • Why type of smoke generating equipment and placement of video equipment is important in order to assess risk
  • Residue considerations; cleaning after completion of airflow visualization studies
2:00 PM - 3:00 PM
Establishing a risk based sample sites to maintain current industry thinking
  • Sample site locations in relationship to placement of probes, plates, fixtures, particle counters and active air samplers
    • Particle monitoring
    • Active air sampling
    • Passive air sampling
3:00 PM – 3:15 PM
Mid-Afternoon Refreshment Break
3:15 PM – 4:00 PM
Selection of particle counting instruments/systems/ notification systems
  • Type of particle counter
  • Installation of particle counter and sampling probe location
  • Operator notification/interface
  • Data: Reporting, retention and security
4:00 PM – 4:45 PM
Selection of viable particle sampling/ real time microbial detection (New Technology)
  • New technologies are being addressed in changing guidances, understand type of viable particle counter updated technologies
  • Continuous monitoring of viable particles-benefits and challenges
4:45 PM – 5:00 PM
Questions and Answers and discussions
5:00 PM
Conclusion of Day 1
Day 2 Course Agenda & Contents
8:00 AM – 8:30 AM
Continental breakfast
8:30 AM – 9:15 AM
Frequency of monitoring to adequately address risk
  • Understand the requirements for cleanroom classification testing per the new ISO standard and changing EU Annex 1 and those for routine environmental monitoring
  • Use product type and risk to patient to establish a reasonable frequency for monitoring
9:15 AM – 10:00 AM
Performance qualification-First step to address risk
  • Setting limits for sterile and non-sterile using a myriad of guidances-evaluation of the applicability of each guidance
  • Value in performing a baseline study before establishing action levels for environmental monitoring
  • Planning a disinfection and cleaning strategy; why chemical kill and physical removal are equally important
  • Establish length of microbiological PQ of environment and gases to collect relevant data evaluate hot spots that may pose risk to product; and which risk assessment tools can be used
  • Know the operational risks before performance qualification testing
10:00 AM - 10:15 AM
Mid-morning Refreshment Break
10:15 AM – 12:00 PM
Establishing a Risk Based EM Program
  • Strategy for reasonable monitoring without overkill
  • Operational risks during monitoring: common errors in choice of media, management of media, and incubation
  • Revising limits-errors to avoid
  • Key elements of an EM procedure-cannot generate good data without a sound procedure
  • Adequate data recording-first component for assessing risk
  • Managing EM data for purposeful trending
  • Microbial identification
    • What is objectionable in your product?
12:00 PM - 1:00 PM
Networking Lunch
1:00 PM - 3:00 PM
Trend Analysis- What does the data mean?
  • USP <1116>; how does it apply during trending
  • Trending excursions vs. organisms-the key to foresee risk to product and patient
  • Using data trends to identify facilities, gowning, cleaning and other deficiencies
  • Key element of an EM summary report to assess risk to product and patient
3:00 PM – 3:15 PM
Mid-Afternoon Refreshment Break
3:15 PM - 4:15 PM
Investigating Environmental Monitoring Excursions
  • Developing and action plan when an excursion occurs
    • Planning an investigation-information to be collected
    • Three step approach-Estimated cause(s), Probable cause(s), Root cause
    • What are corrective actions and how effective are they
    • When is it appropriate to use EM data as a product release criterion?
4:15 PM – 5:00 PM
Questions and Answers and discussions
5:00 PM
Conclusion of Program
Who will benefit:

This program is set up to eliminate the confusion between regulatory requirements, inspectors’ expectations and the changes to ISO standards and upcoming EU Annex 1 changes. FDA observations, warning letters and case studies will be used to clarify regulatory expectations for sterile and non-sterile facilities.

Which industries does this workshop apply to?
Pharmaceuticals, Biotechnology, Medical Device, In Vitro Diagnostics, Food, Beverage, Pharmacies and Technology Companies

Who will benefit?
QC Microbiology, Quality Assurance, Regulatory, Training, Validation, Facilities, and Certification Personnel
Registration Fee & Discounts
Early Bird:
Till January 06, 2017
Discounted Price:
January 07, 2017 to January 31, 2017
Regular Price:
February 01, 2017 to March 02, 2017
$788 +HST CAD $888 +HST CAD $988 +HST CAD
Academia / Government
At all time (Save Over $250.00)
$688 +HST CAD

Group Registration Discount

Special group rates available for 3 or more registrants. Some restrictions apply. For more details please contact us: By email: enquiry@ipacanada.com or Call: 416-410-7402

Registration Fee Includes:

The fee is payable in advance and includes continental breakfast, lunch & refreshments, course material and certificate of attendance.

Cancellation Policy

Cancellations received in writing more than 3 weeks before the event will be subject to a service charge of $150.00 CAD. The full conference fees remain payable if cancellations are received less than 3 weeks prior to the event. Substitutions are welcome at any time. It may be necessary for reasons beyond the control of the organizer to alter the timing of the program or the identity of the speakers. In the unfortunate event that an event is cancelled IPA are not liable for any costs incurred by delegates in connection with their attendance.

Course Venue and Hotel Accommodation
Holiday Inn Montreal Aeroport- Airport
6500 Cote De Liesse Montreal, Quebec H4T1E3 Canada
Telephone: 514-739-6440

Special Room Rate
IPA has arranged a special room rate for attendees at the Holiday Inn Montreal Aeroport- Airport (Conference Venue). To reserve a room at the Holiday Inn with our group rate, please call the hotel directly and mentioned IPA. Note guests are responsible for their own accommodations.

Nearby Hotel:
Crowne Plaza Montreal Airport
Hotel Front Desk: 1-514-344-1999
Guests are responsible for their own accommodations. Please call the hotel directly.

CTD/eCTD content and format
November 29-30 2016 | Montreal, Canada
More Details
Advanced Regulatory Affairs
January 24-26, 2017 | Toronto, Canada
More Details


IPA is the premier Canadian provider of training and skill development seminars, conferences, and expositions for professionals engaged in pharmaceutical, biotechnology, medical device, natural health products, cosmetics, and Allied industries.


Tel: (416) 410-7402
Email: enquiry@ipacanada.com


Stay connected with IPA upcoming events and services. Please click here to opt in and update your email preferences.