Dates: January, 2025
Location: Open Biopharma, Carlsbad, CA
This 1-day course is an in-depth, in-person, training course on how to establish an effective and comprehensive Environmental Monitoring (EM) for sterile product manufacturing as well as for ATMPS, low-bioburden products and/or non-sterile products and compounding pharmacies. This course will provide comprehensive knowledge of the basics of EM, the regulatory and compendial requirements for EM, how to perform a risk assessment for your EM Program and requirements for EM Performance Qualification (EMPQ).
During this course, participants will learn about FDA and EU Annex 1 requirements for EM, USP 1115 & 1116, basics of environmental monitoring (traditional and modern EM equipment, types of media, incubation schemes, analyst training, etc.), how to perform and EMRA, differences between cleanroom classification, EMPQ and routine EM. Let’s get back to basics in this interactive course and discuss everything you need to know to have an effective environmental monitoring program.
WHO SHOULD ATTEND
⦁ Environmental Monitoring analysts/supervisors/managers
⦁ Contamination Control Strategy Specialists, Managers
⦁ Microbiology leadership
⦁ Quality Assurance leadership
⦁ Internal/External auditors
Upon completion of this course, participants will be able to:
⦁ Understand and interpret US and EU requirements for EM
⦁ Describe the elements that should be included in the EM Program
⦁ Develop and implement an effective EMPQ
⦁ Develop and document an EM risk assessments
⦁ Describe how to measure the effectiveness of the EM Program
⦁ Understand what EM regulatory and reference documents are available to aid in your EM Program
Marsha Steed
Founder and CEO Steed MicroBio LLC
Course Registration Price
$1050
General Terms and Conditions: Steed MicroBio LLC will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in this Steed MicroBio event. Steed MicroBio reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event is cancelled, registrants will be notified by Steed MicroBio immediately and will receive a credit (registration fee paid). Steed MicroBio will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and instructors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all Steed MicroBio events.
Environmental Monitoring (EM) Best Practices Training Course
Basics of EM, EMPQ and EM Risk Assessment
Agenda – 1 Day Course
8:00 Arrival – Breakfast pastries/coffee
8:30 Welcome and Introductions
9:00 Lecture: Background and Regulations for EM
⦁ Annex 1 requirements for EM
⦁ FDA requirements for EM
⦁ Key terms
⦁ USP 1115, 1116 chapters for EM
⦁ Background on EM
⦁ Basics of Microbiology
9:30 Lecture: Basics of EM
⦁ Basics of EM
⦁ Equipment – traditional and modern
⦁ Media selection
⦁ What should I use if I get molds in my facility?
⦁ Incubation schemes
⦁ 1 temp, 2 temps
10:30 Break – snacks/beverages
10:45 Lecture: Classification and EMPQ
⦁ ISO 14644-1 Classification
⦁ Environmental Monitoring Performance Qualification Requirements and Best Practices
⦁ Tools to aid (BioPhorum EMPQ)
⦁ Prerequisites to EMPQ
⦁ EMPQ sample locations
⦁ Room Occupancy States
⦁ Number of Runs to Perform
⦁ Baseline EM
⦁ Acceptance Criteria
12:00 Lunch Break
1:00 Lecture: Continuation of EMPQ
⦁ Tools to aid (BioPhorum EMPQ)
⦁ Prerequisites to EMPQ
⦁ EMPQ sample locations
⦁ Room Occupancy States
⦁ Number of Runs to Perform
⦁ Baseline EM
⦁ Acceptance Criteria
2:00 Break
2:15 Lecture: How to Perform EM Risk Assessment
⦁ Prerequisites to an EMRA
⦁ Tools for EMRA
⦁ Risk Toolbox tools that work best for EM
⦁ Risk Factors to Evaluate and Score in the EMRA
⦁ Documentation
⦁ Actions for High-Risk Results
3:30 Interactive Activity: Sharing Current EM issues
⦁ Review your current EM, EMRA and/or EMPQ issues and get group and expert feedback
4:15 Q & A Day 1
4:30 End Day 1
Training Course Location
Open Biopharma Research and Training Institute
1958 Kellogg Ave., Carlsbad, CA 92008, USA
Accommodations
The following hotels are located near the training course location:
The following hotels are located near the training course location:
Courtyard by Marriott
5835 Owens Ave
Carlsbad, CA 92008
Hampton Inn Carlsbad-North San Diego County
2229 Palomar Airport Rd
Carlsbad, CA 92011
Homewood Suites by Hilton Carlsbad-North San Diego County
2223 Palomar Airport Rd
Carlsbad, CA 92011
Fairfield Inn & Suites by Marriott San Diego Carlsbad
1929 Palomar Oaks Way
Carlsbad, CA 92011
How To Get Here:
By Air – The nearest airport is San Diego International Airport (SAN)
Transportation to Open Biopharma:
Open Biopharma has a parking lot at the facility.