Dates: October 29, 2024
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.