Sterile Product Manufacturing Facilities:
Applying the ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation (T12)
Mon 17, Fri 21 Aug 2020: 2.00 - 6.30pm (SGT)
Mon 24 Aug 2020: 2.00 - 5.15pm (SGT)
Objectives
This course uses the second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to provide an understanding of the key requirements and GMPs for sterile manufacturing facilities. The Guide provides valuable information on design, while the USFDA's Guidance helps professionals understand the regulatory context and expectations for sterile drug manufacturing.
Immediately apply the course learning objectives using the electronic download of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition) you'll receive by attending this course.
Using the referenced documents, this course will cover regulatory philosophy, aseptic process and equipment considerations, aseptic clean room design and operation, differential pressure requirements, airlocks, air filtration, HVAC design considerations, and a brief introduction to barrier isolation technology. (Note: parts of Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice that do not focus on facilities and equipment will not be discussed in detail.)
In addition, the course will include an exercise in the layout of an aseptic filling facility. In many cases, when a new facility is required within an existing or new building, the designer will begin by sketching a floor plan. This exercise will demonstrate how to use process flow diagrams and an accommodation schedule to thoroughly define facility requirements before advancing to the floor plan layout stage.
Course Modules
- Introduction to the Baseline Guide
- Concepts and Regulatory Philosophy
- Process and Equipment Considerations
- Architecture and Layout
- Environmental Control Requirements
- HVAC Systems
- Control & Instrumentation
- Commissioning and Qualification
- Barrier-Isolator Technology
- Exercises
- Supplemental Materials
Who Should Attend
- Engineers, validation scientists, quality assurance specialists, and manufacturing managers
- Professionals who want a fundamental understanding of sterile manufacturing facilities and their design, renovation, and operation
- Engineering firm professionals and other consultants who work with the pharmaceutical industry
- NOTE: Participants interested in commissioning and qualification should attend theScience and Risk-based Commissioning and Qualification - Applying the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification training course.
Additional Course Details
Take Back to Your Job
- Understand the regulatory impact on design, construction, and the regulatory context and expectations for sterile drug manufacturing including the use of RABS and isolator systems
- Identify sources of contamination in aseptic operations
- Explain methods for contamination control
- Describe the major requirements for design, renovation, and operation of a sterile manufacturing facility
- Discuss the fundamentals of aseptic clean room design
- Understand the importance of monitoring critical parameters: temperature, humidity, air velocity, differential pressure, airflow patterns, non-viable particle counts, and microbial counts
- Design a systematic process for aseptic facility layout
- Apply ISO 14644-1:2015, Clean Rooms and Associated Controlled Environments - Part 1: Classification of Air Cleanliness to pharmaceutical manufacturing facilities, and the relationship with the GMP requirements
- Distinguish between the 2004 and 1987 versions of the FDA's Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice as applied to the design, operation, maintenance, and modification of facilities
Community of Practice (COP)
This training course is of particular interest to existing and future members of the ISPE Sterile Products Processing (COP).
About the Speakers
Pierre Winnepenninckx, CEO, No deviation, Singapore & Conference Chair, ISPE Singapore Affiliate
Pierre played a leading role in the Design and Qualification of several process equipment in GSK Bio (2001-2011). Since starting his consultancy company in 2007, he has supported several Commissioning and Qualification projects in Singapore and China focussing on a risk based approach and ASTM2500E guidance.
Pierre possesses a scientific mindset which is complemented by the practical approach acquired during his years as an engineer. This combination makes him a perfect fit for Design and Commissioning activities in a field that requires science and productivity.
Actively involved in ISPE since 2012, he helps the association to share knowledges and best practices. Pierre holds a Bachelors degree in Chemistry from the University of Liege and a Masters in Chemical Engineering from the Universite libre de bruxelles (Belgium).
Bruce S Davis, Principal, BD Global Consulting
Bruce runs his own Company for training and consultancy in pharmaceutical science and risk-based approaches, including for example Quality risk management, Process Validation, qualification, GMP for Engineers and Technology Transfer. He is a professional engineer and has many years' experience in the pharmaceutical industry and a wide international knowledge.
Bruce is an Associate to NSF Health Sciences and is based in the UK. He previously worked at AstraZeneca, where he had several responsibilities, including managing international engineering. A member of ISPE since 1991, Bruce held the position of Chair of ISPE International Board of Directors and has co-led teams for several ISPE Good Practice Guides including Technology Transfer. He is an international trainer for ISPE in multiple subjects, and has carried out training in EU, US, Japan and other countries in Asia-Pacific.
Daily Schedule at a Glance
| Mon 17 & Fri 21 August 2020 | |
|---|---|
| 1345 - 1400 | Login & Registration |
| 1400 - 1415 | Introductions |
| 1415 - 1600 | Course Content & Exercises |
| 1600 - 1610 | Break |
| 1610 - 1815 | Course Content & Exercises |
| 1815 - 1830 | Wrap-up, Questions & Discussions |
| Mon 24 August 2020 | |
|---|---|
| 1345 - 1400 | Login & Registration |
| 1400 - 1415 | Recap |
| 1415 - 1530 | Course Content & Exercises |
| 1530 - 1535 | Break |
| 1535 - 1630 | Course Content & Exercises |
| 1630 - 1715 | Wrap-up, Questions & Discussions |
All timings are displayed in Singapore Time
Registration Fee in Singapore Dollars
Conducted online, this is a unique opportunity to attend world-class training at an affordable price. In-person attendance usually costs S$ 1,395 in Singapore or US$ 1,495 in USA!
EARLY (On or Before 31 Jul)
- Member S$ 395
- Nonmember S$ 595
STANDARD (On or After 1 Aug)
- Member S$ 495
- Nonmember S$ 695
Group (3 or more) / Others
- Group: Member S$ 395
- Group: Nonmember S$ 595
- Emerging Market* S$ 295
- Government/Academia S$ 295
- Student S$ 80
*To qualify, attendee must be based in the Emerging market country