|
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 seminar will present 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 and group discussions will be used to demonstrate
such approaches and to guide participants through lessons learned by experienced
practitioners. Current trends, such as use of disposables and cell culture
technologies, will be discussed.
This is an advanced level course.
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 seminar 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.
EXPERT
PANEL:
- DIRECTOR:
Antonio
Moreira, Chairman, Peritus Consultants, Inc
- Alison
Demarest, Principal, Meridian BioGroup LLC
- Marta
I. Murray, Director QA Engineering, Abbott Laboratories
- Rich
Yeaton, Principal, East Coast Validation Services, LLC
AGENDA
|
Monday,
10 November |
| 8:00-8:15
am |
Opening
Remarks - Course Introduction and Overview
- Antonio Moreira, Chairman,
Peritus Consultants, Inc |
| 8:15-10:00
am |
Principles of Validation
This session provides the general background for the seminar. 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, Chairman, Peritus Consultants, Inc
|
| 10:00-10:30
am |
Coffee
Break |
| 10:30-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 session describes what is typically
included in the master plan, how to prepare one, and its value to
the validation process.
- Alison
Demarest, Principal, Meridian BioGroup LLC |
|
Noon-1:00 pm |
Lunch |
| 1:00-2:00
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.
-
Alison Demarest, Principal, Meridian BioGroup LLC
|
| 2:00-3:00
pm |
Case
Study Exercises in Validation Planning
This session will use real life case studies in a group team work/panel
discussion format. Participants will have the opportunity to develop
workable solutions for situations presented by the instructors or
of the participants own interest.
Panel:
Alison Demarest, Antonio Moreira, Marta I. Murray, Rich Yeaton
|
| 3:00-3:30
pm |
BREAK;
coffee/refreshments |
|
3:30-5:00
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 is included.
- Marta I. Murray, Director QA Engineering,
Abbott Laboratories |
|
Tuesday,
11 November |
| 8:00-10:00
am |
Facilities
Validation: High Purity Water Systems
Systems for the production of biopharmaceutical process water
represent another key component of a manufacturing facility. This
session 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, Principal,
East Coast Validation Services, LLC |
| 10:00-10:30
am |
Coffee
Break |
| 10:30-Noon |
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 needs to be collected are presented
in this lecture.
- Antonio
Moreira, Chairman, Peritus Consultants, Inc
|
| Noon-1:00
pm |
Lunch |
| 1:00-3:00
pm |
Validation
of Steam Sterilization Processes
Steam sterilization is a critical operation in any bio-manufacturing
process, including sterilize-in-place process equipment such as bioreactors
and filtration equipment, as well as support equipment such as autoclaves.
This session will discuss the development of validation protocols
for these systems and the establishment of achievable acceptance criteria
- Rich Yeaton, Principal, East
Coast Validation Services, LLC |
| 3:00-3:30
pm |
BREAK;
coffee/refreshments |
|
3:30-5:00
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.
-
Rich Yeaton, Principal, East Coast Validation Services, LLC
Case
Studies on Validation of Bioprocessing Equipment and Systems –
PANEL DISCUSSION
This session will present an audience-interactive panel discussion
on various real life examples of validation projects.
Panel: Rich
Yeaton, Antonio Moreira, Alison Demarest, Marta I. Murray |
5:00-6:00
pm |
Keynote |
| 6:00-7:00
pm |
Cocktail
Reception (with Exhibitors) |
|
Wednesday,
12 November
|
|
8:00-10:00
am
|
Validation
of Bioprocesses
This session 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, Chairman, Peritus Consultants, Inc |
|
10:00-10:30
am
|
Coffee
Break |
|
10:30-Noon
|
Cleaning Validation
This session 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.
-
Marta I. Murray, Director QA Engineering, Abbott Laboratories
|
|
Noon-1:00 pm
|
Lunch |
|
1:00-3:00
pm
|
Case
Studies in Validation
This session will present in a discussion format various case studies
dealing with validation of facilities and processes for biological
products. Throughout the course, attendees will have the opportunity
to suggest topics for this session. Specific subjects addressed
could include, for example:
- Validation
of removal of process contaminants
- Validation
of disposable systems
- Re-validation
strategies
- Validation
of legacy systems/processes
Panel: Alison
Demarest, Antonio Moreira, Marta I. Murray, Rich Yeaton
|
|
3:00-3:30
pm
|
BREAK;
coffee/refreshments |
|
3:30-5:00
pm
|
Panel
Discussion: New Developments in Validation
This session will discuss new approaches and trends for validation
of facilities and processes. Topics will include:
- Quality
by design; process development considerations
- ICH
Guidelines
- ASTM
Standards
Panel:
Antonio Moreira, Rich Yeaton,
Alison Demarest, Marta I. Murray
|
REGISTER
NOW! Visit www.asmeconferences.org/Bioprocess08
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