Aseptic Behaviors for
Isolators Nov 19 - 21
Aseptic Behaviors for
Isolators Nov 19 - 21
Aseptic Behaviors for Isolators Nov 19 – 21, 2024 Raleigh, NC
This 2.5 days course is an in-depth, hands-on training course on aseptic behaviors using isolators for sterile product manufacturing. This course will provide comprehensive knowledge of proper aseptic processing behaviors to ensure contamination control.
During this course, participants will learn about basics of microbiology, aseptic necessities during aseptic processing, basics of isolator technology, Vaporized Hydrogen Peroxide (VHP) decontamination and validation of isolators, FDA and EU (Annex 1) regulations for aseptic processing, environmental monitoring, isolator set-up and parts change over processing, proper aseptic movements in isolators, cleaning and disinfection of cleanrooms and isolators, gowning for aseptic processing in isolators, proper isolator glove use, isolator glove leak testing, sterile filtration of drug products/PUPSIT and risk assessments, aseptic processing simulations, intervention risk assessments, investigating APS failures, and air visualization studies in isolators.
At the end of the course, there will be an ask the experts session with the instructors as well as ex-FDA regulators from Jeff Yuen & Associates.
Dates: November 19 – 21, 2024
Location: SKAN US HQ, Raliegh, NC
This 2.5 days course is an in-depth, hands-on training course on aseptic behaviors using isolators for sterile product manufacturing. This course will provide comprehensive knowledge of proper aseptic processing behaviors to ensure contamination control.
During this course, participants will learn about basics of microbiology, aseptic necessities during aseptic processing, basics of isolator technology, Vaporized Hydrogen Peroxide (VHP) decontamination and validation of isolators, FDA and EU (Annex 1) regulations for aseptic processing, environmental monitoring, isolator set-up and parts change over processing, proper aseptic movements in isolators, cleaning and disinfection of cleanrooms and isolators, gowning for aseptic processing in isolators, proper isolator glove use, isolator glove leak testing, sterile filtration of drug products/PUPSIT and risk assessments, aseptic processing simulations, intervention risk assessments, investigating APS failures, and air visualization studies in isolators.
At the end of the course, there will be an ask the experts session with the instructors as well as former FDA regulators from Jeff Yuen & Associates.
WHO SHOULD ATTEND
- Aseptic Processing Operators
- Manufacturing Supervisors, Managers
- Quality Assurance Specialists, Managers
- Contamination Control Strategy Specialists, Managers
Upon completion of this course, participants will be able to:
- Understand and interpret US and EU regulations on aseptic processing and isolators
- Describe isolator technology and how VHP decontamination and validation is performed
- Create a risk based environmental monitoring program for inside an isolator and its associated cleanrooms
- Perform handling of EM plates and swabs in isolator gloves
- Understand basic microbiology concepts and understand how contamination is controlled
- Develop a risk based aseptic processing simulation program
- Perform an intervention risk assessment
- Assess proper and improper aseptic behaviors in isolators
- Create and interpret air visualization studies for isolators
- Perform proper glove entry using isolator gloves
- Perform isolator parts change over properly for aseptic processing
- Describe how to properly clean, disinfect and surface decontaminate an isolator
- Understand basics of sterile filtration and requirements for PUPSIT
ISOLATOR HANDS ON ACTIVITIES
- Proper glove usage including glove entry/exit
- Glove leak testing and visual inspection
- Collecting air and surface EM samples inside of an isolator (handling contact plates, settle plates and swabs)
- Aseptic behaviors inside an isolator (proper movements inside an isolator, transferring materials in and out of an isolator)
- Cleaning and disinfection inside an isolator
Marsha Steed
Lead Instructor – Marsha Steed, Founder and CEO Steed MicroBio LLC and Microbiology Expert Consultant Jeff Yuen & Associates
Marsha Steed has over 30 years of experience as a microbiologist working in the Pharmaceutical, Biotechnology and Medical Device fields. Marsha is the Founder and President of Steed MicroBio, LLC which is an independent microbiology consulting firm and a Senior Microbiology Associate/Sterility Assurance Expert at Jeff Yuen & Associates, Inc. consulting firm. Marsha is a globally recognized consultant specializing in sterility assurance and contamination control matters in pharmaceutical, biotech and medical device companies. Marsha is a USP Microbiology Expert Committee member and the chair of the USP Microbial Control and Sterility Assurance Subcommittee. Marsha studied Biology at Western New England University in Springfield, MA.
Les Edwards
Instructor – Les Edwards, VP Technology and BD at SKAN US
Les Edwards is currently VP Technology and Business Development for SKAN US (since 2011), the Swiss-based worldwide leader in pharmaceutical aseptic isolators. Les’ career in aseptic pharmaceutical and biologics manufacturing has been a mix of development, technical and executive roles in which he has been responsible for managing projects and deploying advanced solutions for aseptic manufacturing worldwide. As a subject matter expert in Aseptic Processing, Isolation/Containment Technology and H2O2 biodecontamination, Les has spoken well over 100 times on these topics in global settings since the early 1990s. Les holds a Bachelor of Science in Bioengineering and a Masters in Technology Management, both from the University of Pennsylvania (School of Engineering / Wharton School of Business) in Philadelphia.
Erwin Andrews
Instructor – Erwin Andrews, Senior Consultant & Aseptic Processing Expert, Jeff Yuen & Associates
Erwin Andrews has 17 years of experience in the pharmaceutical industry. Those 17 years have consisted of aseptic manufacturing leadership and quality assurance leadership roles. In these roles, Erwin has focused on instilling a quality mindset in his organizations. Prior to joining Jeff Yuen and Associates, Erwin worked with leading commercial and contract pharmaceutical companies (Merck, Novo Nordisk, Catalent, Emergent, and Pharmaceutics International, Inc.). Erwin developed a strategic vision for his teams and worked with them to accomplish the vision. Erwin has a BS degree from North Carolina Agricultural and Technical State University.
Merritt Postma
Instructor – Merritt Postma, Executive Director of North America Sales, SKAN US
Merritt Postma is the Executive Director, North American Sales for SKAN US in Raleigh, NC. For the last eight years, he has specialized in decontamination and isolator technology. Since 1997, Merritt has been involved in many aseptic filling, freeze drying, and packaging line projects. He is passionate about using new technology and automation to increase sterility assurance and provide safer products to the patients and greater protection to the operators. He is a past president and current board member of the ISPE LA Chapter.
Zoe Reilly
Instructor – Zoe Reilly, Process Applications, SKAN US
Zoe Reilly is the SKAN US Process Applications Specialist, serving as the in-house Subject Matter Expert for Sterility Testing and Advanced Therapy Medicinal Products (ATMPs). With a robust background as the Sterility Testing Technical Lead at a major pharmaceutical company, Zoe has engaged in numerous discussions with major regulatory bodies and supported a significant facility transfer for a sterility testing laboratory. Her extensive experience with barrier isolators and passion for sterility testing led her to SKAN, where she continues to apply her expertise to advance the field.
Course Registration Price
$3299
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 JYA/SKAN event. JYA/SKAN 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). JYA, Steed MicroBio and SKAN will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, 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 JYA/SKAN events.
Disclaimer
Aseptic Behaviors for Isolators
Agenda – 2.5 Days Course
Day 1
8:00 Arrival – coffee
8:30 Welcome and Introductions
9:00 Lecture: Basics of Microbiology and Aseptic Necessities
- Basics of Microbiology
- First Air Principles
- Facility/Cleanroom Design for Isolators
- Layout and Flows
- Gowning for Isolators
- Material transfer into an isolator
10:00 Lecture: Annex 1 Guidance and FDA Regulations for Aseptic Processing
- Annex 1 requirements for aseptic filling
- FDA aseptic processing requirements
- Regulatory requirements for isolators
- Aseptic Processing Key Terms
- Background of aseptic processing
11:15 Lecture: Isolator 101 and VHP Decontamination and Validation
- Isolator Design, use, and function
- Vaporized Hydrogen Peroxide (VHP) and SKANFog© Decontamination
- Microbial Validation with biological indicators
12:15 Lunch Break
1:15 Lecture/Video Reviews: Set-up of isolator change parts
- Lecture and video review
- Direct and indirect product contact part installation sequences
- Do’s and Don’ts to avoid introduction of contamination
2:45 Break
3:00 Hands on Activities Using Isolators
- Environmental Monitoring Sampling
- Glove Use and Leak Testing
- Aseptic Movements
4:00 Q & A Day 1
5:00 End Day 1
Day 2
8:00 Arrival – coffee
8:15 Day 1 Review – Q & A
8:30 Lecture: Environmental Monitoring (EM) in Isolators
- Basics of EM
- Viable air sampling – active and passive
- Nonviable air sampling
- Surface sampling
- Swab sampling
- Selecting appropriate swabs
- Developing a swabbing technique
- Changing plates in an isolator
- Removing plates from an isolator
- Risk Based EM sample locations
10:00 Lecture Sterile Filtration
- Regulatory requirements for sterile filtration, FDA and Annex 1
- Filter validation for bacterial retention
- Filter integrity testing: PUPSIT or not?
- Filter integrity testing
10:45 Break
11:00 Lecture Air Visualization Studies and CFD Analysis
- Static versus dynamic
- Regulatory Aspects
- Proper movements to maintain unidirectional airflow
- Training operators on smoke study Do and Don’t Videos
12:00 Lunch
1:00 Hands on Activities Using Isolators
- Environmental Monitoring Sampling
- Glove Use and Leak Testing
- Aseptic Movements
2:00 Aseptic Processing Simulations (APS) Media Fills
- Regulations
- Interventions in an isolator
- Intervention Risk Assessment
- Investigating APS failures
3:30 Break
3:45 Q & A Day 2
4:45 End Day 2
5:00 Happy Hour Event (in Brier Creek)
7:00 End Happy Hour Event
Day 3
8:00 Arrival – coffee
8:30 Day 1 and 2 review and questions
- Open Q & A
9:00 Lecture: Cleaning and Disinfection and Glove Use
- Cleanroom cleaning and disinfection
- Isolator cleaning and disinfection
- Proper Glove Use
- Glove entry/exit
- Glove Integrity Testing
- Troubleshooting glove leak test failures
10:00 Hands on Activities Using Isolators
- Environmental Monitoring Sampling
- Glove Use and Leak Testing
- Aseptic Movements
11:00 Break
11:15 Ask The Experts – Panel
12:15 End Day 3 – Wrap Up & Survey
Travel
Training Course Location
SKAN US Headquarters
7409 ACC Blvd., Raleigh, NC 27617, USA
Accommodations
The following hotels are located near the training course location:
The Westin Raleigh-Durham Airport
Address: 3931 Macaw St, Raleigh, NC 27617
Embassy Suites by Hilton Raleigh Durham Airport Brier Creek
Address: 8001 Arco Corporate Dr, Raleigh, NC 27617
Phone: 919-572-2200
Hampton Inn & Suites Raleigh-Durham Airport-Brier Creek
Address: 8021 Arco Corporate Dr, Raleigh, NC 27617
Phone: 919-484-0500
How To Get Here:
By Air – Raleigh Durham Airport (RDU)
Transportation to SKAN:
Please utilize rideshare to get from hotel to SKAN.
Parking is VERY limited at SKAN. If you drive, please park on the street.
RIDESHARE TO TRAINING FACILITY HIGHLY ENCOURAGED!!!
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 Contamination Control Strategy (CCS) for sterile product manufacturing as well as considerations for ATMPS, low-bioburden products and/or non-sterile products. This course will provide comprehensive knowledge of the elements that should be included in a CCS and will evaluate different document structures for a CCS.
During this course, participants will learn about Annex 1 requirements for CCS, elements of a CCS, relationships of contamination control risk assessments performed to the CCS (A CCS is NOT a risk assessment but should reference the risk assessments that have been performed), process and facility design, facilities and equipment, personnel, utilities, raw material controls, containers and closures, vendor approvals, management of outsourced activities, quality risk management, process validation, validation of sterilization processes, preventative maintenance, trends, CAPAs, continuous improvement and determine the best, most practical templates to document your CCS.
Working on your company CCS now and struggling? Bring your draft and get expert review and feedback on how to improve and finalize it.
WHO SHOULD ATTEND
⦁ Contamination Control Strategy Specialists, Managers
⦁ Microbiology leadership
⦁ Quality Assurance leadership
⦁ Internal/External auditors
⦁ MSAT
Upon completion of this course, participants will be able to:
⦁ Understand and interpret US and EU requirements for CCS
⦁ Describe the elements that should be included in the CCS
⦁ Develop and implement an effective CCS document
⦁ Understand how microbial risk assessments support the CCS
⦁ Describe how to measure the effectiveness of the CCS
⦁ Understand what CCS reference documents are available to aid in your CCS creation
Marsha Steed
Founder and CEO Steed MicroBio LLC
Course Registration Price
$1099
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.
Development of an Effective Contamination Control Strategy (CCS)
Agenda – 1 Day Course
8:00 Arrival – Breakfast pastries/coffee
8:30 Welcome and Introductions
9:00 Lecture: Annex 1 Guidance and FDA Regulations for CCS
⦁ Annex 1 requirements for CCS
⦁ FDA views for CCS
⦁ Key terms
⦁ Elements of a CCS per Annex 1
9:30 Lecture: Development and Documentation of a Company’s CCS
⦁ Industry Guidance available
⦁ Stages to developing and documenting a CCS
⦁ Template Ideas
⦁ Structure Ideas
⦁ Approach to
⦁ DOs and DON’Ts of writing your CCS
⦁ How to Structure the Document for CDMO or Multi-Site
⦁ What about ATMP and low-bioburen, non-steriles?
10:45 Break – snacks/beverages
11:00 Lecture: CCS Elements Key Points
⦁ Review all required elements and what to include in your CCS under each one
⦁ Design of Plant and Process
⦁ Facilities and Equipment
⦁ Personnel
⦁ Utilities
⦁ Raw Material Controls
⦁ Product Containers and Closures
⦁ Vendor Approval
⦁ Management of Outsourced Activities
⦁ Process Risk Assessment
⦁ Process Validation
⦁ Validation of Sterilization Processes
⦁ Preventative Maintenance
⦁ Cleaning and Disinfection
⦁ Monitoring Systems
⦁ Prevention Mechanisms (Trending, CAPA, etc.)
⦁ Continuous Improvement
12:00 Lunch Break
1:00 Lecture: Continuation of Elements
⦁ Design of Plant and Process
⦁ Facilities and Equipment
⦁ Personnel
⦁ Utilities
⦁ Raw Material Controls
⦁ Product Containers and Closures
⦁ Vendor Approval
⦁ Management of Outsourced Activities
⦁ Process Risk Assessment
⦁ Process Validation
⦁ Validation of Sterilization Processes
⦁ Preventative Maintenance
⦁ Cleaning and Disinfection
⦁ Monitoring Systems
⦁ Prevention Mechanisms (Trending, CAPA, etc.)
⦁ Continuous Improvement
2:30 Break
2:45 Lecture: Effectiveness Checks and Maintaining Your CCS
⦁ How Often to Revise the CCS
⦁ Management Review of the CCS
3:15 Interactive Activity: Sharing Current CCS
⦁ Review your current CCS drafts and get 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.
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.