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Testimonials:
A
truly excellent seminar and a MUST for anyone looking for a detailed
overview of industry trends from the technical leaders in the area.
- Ken Carroll, Head of Dept. of Science, Institute of Technology Tallaght
- Dublin
An
excellent way to acquire a mixture of broad and detailed knowledge about
bioprocess equipment design factors.
- Val Peyton, Group Quality Manager, PM
Group, Ireland
Bioprocess
Equipment Design seminar provides a fast and efficient way of learning
a little bit of the whole chain from design to production.
- Josef Alenius, Quality Manager, Texor AB, Sweden
These
seminars should be integral to the biotech industry and help harmonise
important issues.
- Peter Kierans, Sales Director, Optima Pharma Group, UK
VIEW
OTHER TESTIMONIALS
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| PD485:
Validation of Biopharmaceutical Facilities & Processes |
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Date: October
1-3, 2007 (Monday-Wednesday)
CEUs: 2.25
Description
Validation of facilities, equipment and critical process steps utilized
for the manufacture of biological products is required in order to comply
with regulatory requirements from government agencies such as the US Food
and Drug Administration. The design and execution of an adequate validation
program will assure that the facilities used in manufacturing are appropriately
established and maintained conforming to design specifications and the
production process is under an appropriate state of control. These elements
represent a key contribution to assuring the final quality of the biological
product manufactured.
This course presents a detailed discussion of the approaches that a biopharmaceutical
company can take in order to implement a validation program that will
achieve the ultimate goal of complying with the regulatory requirements
for validation in an evolving environment. Examples from real case situations
will be used to demonstrate such approaches and to guide participants
through lessons learned by experienced practitioners.
What You Will Learn
- An integrated
view of the validation efforts required of a biopharmaceutical manufacturer
- Workable
approaches for implementing a validation program
- Examples
of Validation Master Plan and validation protocol preparation
- The latest
trends in FDA regulatory requirements and their relationship to validation
- Strategic
thinking skills toward the validation exercises
- How to
ask the right questions during validation
Who Should Attend
This course is intended for individuals who are involved with manufacturing,
quality functions, engineering, validation, and process development for
biological products. Such individuals can be involved with the design
and construction of a biopharmaceutical facility, the development, operation,
and validation of a bio-manufacturing process, or preparation for licensure.
Schedule
| Sunday,
September 30, 2007 |
| 3:00
pm - 7:00 pm |
Registration Open - Avoid the lines on Monday! |
|
Monday, October 1, 2007 |
| 7:30
am - 8:30 am |
Registration Desk Open; Continental Breakfast |
| 8:30
am - 10:00 am |
Principles
of Validation
This lecture provides the general background for the course. It
includes the key concepts and definitions of validation and identifies
the various approaches that can be taken towards the validation exercise,
including new approaches to validation. |
Antonio
Moreira
Vice Provost, UMBC, & Executive Vice President,
SPI USA, Inc.
|
| 10:00
am - 10:30 am |
Refreshment
Break |
| 10:30
am - 12:00 noon |
Validation
Master Plan
As the first step toward successful validation, many companies develop
a Validation Master Plan that sets out the validation scope, responsibilities
and schedule. This lecture describes what is typically included
in the master plan, how to prepare one, and its value to the validation
process.
Case study: Preparation of Validation Protocols |
|
| 12:00
noon - 1:00 pm |
Lunch |
| 1:00
pm - 2:30 pm |
Preparation
of Validation Documents and Protocols
Adequate and accurate documentation of the validation program is
of paramount importance to a successful outcome and ultimate acceptance
by the FDA of the validation data. This lecture provides examples
of format and content of various validation documents, outlines
responsibilities for preparation and execution, and addresses in-house
execution versus subcontracted validation.
Case
study: Preparation of Validation Protocols (cont'd.) |
|
| 2:30
pm - 3:00 pm |
Refreshment
Break |
| 3:00
pm - 5:00 pm |
Facilities
Validation: HVAC Systems
HVAC systems represent one of the key operational systems in any
biotechnology facility. This segment describes in-depth aspects related
to validation of such systems from initial installation to ongoing
operation. Discussion of case studies on HVAC Systems Validation. |
|
| 5:00
pm - 6:00 pm |
Networking
Hour |
| Tuesday,
October 2, 2007 |
| 7:30
am - 8:30 am |
Registration Desk Open; Continental Breakfast |
| 8:30
am - 10:00 am |
Facilities
Validation: High Purity Water Systems
Systems for the production of biopharmaceutical process water represent
another key component of a manufacturing facility. This lecture discusses
the installation, operational and performance qualification of water
systems, including the common test elements, types of data to be collected,
the frequency and duration of testing, and validation pitfalls. |
Rich
Yeaton
President, East Coast Validation Services, LLC
|
| 10:00
am - 11:00 am |
Validation
of Bioprocessing Equipment
A wide variety of processing equipment is utilized in a typical bio-manufacturing
facility. This equipment includes bioreactors, filtration skids, centrifuges,
chromatography columns, etc. Validation approaches for these types
of equipment and examples of data that need to be collected are presented
in this lecture. |
Antonio
Moreira
Vice Provost, UMBC, & Executive Vice President,
SPI USA, Inc.
|
| 11:00
am - 11:15 am |
Refreshment
Break |
| 11:15
am - 12:00 noon |
KEYNOTE |
| 12:00
noon - 1:00 pm |
Lunch |
| 1:00
pm - 2:30 pm |
Validation
of Steam Sterilization Processes
Steam sterilization is a critical operation in any bio-manufacturing
process, including sterilize-in-place process equipment such bioreactors
and filtration equipment, as well as support equipment such as autoclaves.
This lecture will discuss the development of validation protocols
for these systems and the establishment of achievable acceptance criteria. |
Rich
Yeaton
President, East Coast Validation Services, LLC
|
| 2:30
pm - 3:00 pm |
Refreshment
Break w/ Exhibitors |
| 3:00
pm - 5:00 pm |
Case
Study on Part 11 Compliance
The use of automation and computerization systems is of central
importance in the bio-manufacturing environment. Such systems are
potentially under a requirement for compliance with Part 11 depending
on how the information obtained is used for decision making and
FDA reporting. A case study on Part 11 compliance will be presented.
Case
Studies on Validation of Bioprocessing Equipment and Systems |
Rich
Yeaton
President, East Coast Validation Services,
LLC
All
Instructors
|
| 5:00
pm - 7:00 pm |
Opening
Reception with Exhibitors |
|
Wednesday,
October 3, 2007 |
| 7:30
am - 8:30 am |
Registration Desk Open; Continental Breakfast w/ Exhibitors |
| 8:30
am - 10:00 am |
Validation
of Bioprocesses
This lecture describes approaches that can be taken for validation
of the main steps that typically compose a bio-manufacturing process.
These include cell banking, fermentation/cell culture, early recovery
steps, and chromatographic separations. The critical issues that need
to be addressed are identified. |
Antonio
Moreira
Vice Provost, UMBC, & Executive Vice President,
SPI USA, Inc.
|
| 10:00
am - 10:30 am |
Refreshment Break w/ Exhibitors |
| 10:30
am - 12:00 noon |
Cleaning
Validation
This lecture describes the considerations that need to be addressed
when designing and validating cleaning of the process equipment utilized
in bio-manufacturing systems. Goals of the cleaning program, types
of residues that need to be considered, and mechanisms/approaches
for cleaning are included. CIP systems are discussed. |
|
| 12:00
noon - 1:00 pm |
Lunch
w/ Exhibitors |
| 1:00
pm - 3:00 pm |
Case
Studies in Validation
This final session will present in a discussion format various case
studies dealing with validation of facilities and processes for
biological products. Specific subjects that will be addressed will
include:
- Validation of removal of process contaminants
- Validation of disposable systems
- Re-validation strategies
- Quality by design and new validation concepts |
|
| 3:00
pm - 3:30 pm |
Refreshment
Break w/ Exhibitors |
ASME
Travel Policy : ASME is not responsible for the purchase of
non-refundable airline tickets or the cancellation/change fees associated
with canceling a flight. Please call to confirm that the course is running
before purchasing airline tickets. ASME retains the right to cancel a course
up until 3 weeks of the scheduled presentation date. |
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