Event:
Session:
WASHINGTON 2010 CONFERENCE
Dates:
Location:
Wednesday-Thursday 9-10 June 2010
Washington, D.C.
Science and Risk-based Validation: Using Practical Approaches
Across projects to Break Down Implementation Silos
Session Leader: Mark Hannon, Nick Haycocks
Wednesday, 9 June
Start End Time Presentation Title
Time
Speaker
(Leader/Speaker Breakfast 7:00)
Breakfast
Welcome and Introductions
7:30
9:00
9:00
9:15
9:15
10:00
10:00
10:30
10:30
11:15
Networking Break
Brunelle
Science and Risk-Based Validation: Amgen’s Approach to
Implementation for Equipment Qualification
Amgen has been developing and implementing a risk-based approach to
equipment qualification designed to simplify the process utilizing the ASTM
2500 framework and other guidance. The Amgen model utilizes a crossfunctional risk assessment process supported by Good Engineering
Practices. This allows Quality to focus validation efforts around critical
aspects, verifying that appropriate risk control measures are in place and
functioning correctly. This presentation will introduce the process, show
how the program developed, and provide examples of actual practice.
Challenges encountered and benefits realized will be included.
A Risked-Based Approach to Validating Aseptic Processing and Process
Bowen
Validation
Lunch
Selby
Validation: Is Risk Management Religion or Remedy?
Risk management is promoted as the tool to focus the efforts of the
pharmaceutical industry to where it adds most value whilst at the same time
protecting the patient. Nowhere is this more valuable than in validation
activities. This presentation, will offer an overview of risk management as it
is currently practiced and use examples to illustrate how it can be applied in
validation activities to both the advantage and the disadvantage of the
patient and the company.
A Science and Risk-Based Approach to Establishing a Calibration Program Foss
11:15
12:00
12:00
13:00
13:00
14:00
14:00
15:00
15:00
15:30
16:15
15:30
16:15
17:00
17:00
Hannon
Haycocks
Watler
Implementing a Risk-Based Approach for Process Validation
In this discussion we will explore how to implement the FDA’s Guidance on
Quality Risk Management (ICH Q9) and PDA’s Technical Report 42
concepts to identify high risk factors. FMEA will be used to identify critical
parameters which then streamline the validation effort across stages 1, 2
and 3 of the new FDA process validation guidance. The risk analysis will
identify high risk elements to be mitigated during stage 1 through Quality by
Design practices such as mechanistic and DOE techniques. As validation
advances, the risk analysis will become an integral part in justifying
parameters to study during the intensive commercial qualification stage.
Finally, the risk analysis coupled with statistical process control techniques
such as “short-run” SPC, will be used to develop and streamline the ongoing
process monitoring program.
Networking Break
Risk-Based Approach to the Qualification of a Purified Water System
Zoccolante
Hannon
Internal Audits for Risk-Based Approaches to Qualification
Risk-based approaches are applied to many new process and systems
validations. Companies perform internal quality audits to evaluate
commissioning and qualification in advance of regulatory inspections, such
as PAI, and gauge the conformance to company quality policies. Although
not a regulatory requirement, companies are adopting Pharmaceutical
Quality Systems utilizing Quality Risk Management to both facilitate
regulatory inspections and improve Quality Systems. We will examine the
roles for audits described in ICH Q9 and Q10, and what auditors may look
for in evaluating qualification packages. Discussion is based upon the
principles pioneered in the ISPE Commissioning and Qualification Baseline
Guide and currently being furthered developed by the ASTM E 2500
Standard Guide. Additional, topics include Good Engineering Practice,
requirements for commissioning, use of vendor testing (FAT), evaluating
risk assessments, design verification, reviewing validation records, and
capturing the output of validation into living systems, such as Risk Control
Strategies. Attendees will be familiarized with role of internal qualification
audits for risk based approaches then, review practical applications of audit
principles and identify potential pitfalls.
Seminar Adjourns, Reception
Thursday, 10 June
Start End Time Presentation Title
Time
Speaker
7:00
8:00
8:00
9:00
Breakfast
Quality Risk Management – Driving Focus, Controlling Risks, Improving the Howard
Process
Lambert
Acosta
9:00
10:00
10:00
10:30
10:30
11:15
Managing the Risk of Cross-Contamination: ISPE’s Risk-MaPP Baseline
Wilkins
Guide
Networking Break
A Case Study in Master Soils: Risk Based Approaches for Developing Klewer
Robust and Efficient Cleaning Processes
An important strategy for successful cleaning validation is the development
of robust cleaning cycles. A major obstacle in implementing this strategy is
that manufacturing equipment and process soils are often not readily
available for cycle development, resources which are especially scarce
when a new product is being launched. The above obstacles can be
overcome through the use of bench-scale cleanability studies and
Formulated Master Soilants (FMS). The criteria for selecting a suitable FMS
and a methodology for designing, optimizing, and validating cleaning cycles
will be discussed. A case study will be presented to illustrate the
implementation of a formulated master soil.
11:15
12:00
Wozniak
Quality Risk Management (QRM) -- Its Application to a
Biopharmaceutical
It is time to apply QRM effectively and efficiently. This presentation will lead
us on a journey on how to establish, initiate and formalize your QRM efforts
through a case study. Included will be the importance of management
commitment, documentation and formation of teams as well as compliance
with ICH Q9, and Annex 20 of the PIC/SGMP code of GMP. The
implementation of mitigation measures will demonstrate how QRM will focus
attention on the most critical quality aspects and the sense of success that
implementation of these measure can realize in many workplaces. The
FMEA approach will also be discussed, including the pros and cons of this
methodology for the case study presented.
12:00
13:00
13:00
13:45
Lunch
Butterell
Continuous Quality Verification: An Approach to Process Validation
This presentation will provide an overview of Continuous Quality Verification
(CQV) as an approach to process validation and the circumstances under
which CQV may be used. It will show the primary elements of this approach
as applied to the implementation of continuous processing for an existing
product.
How CQV links to real-time release and the expected
impact
of
p
p
p
CQV on regulatory filing content will also be discussed.
13:45
15:00
Gooen, FDA
FDA Guidance Overview
What is the FDA seeing as companies apply Risk-based approaches, where Godwin, FDA
is the industry compared to expectations. Some generic descriptions,
progress to date, sticky wickets, Q&A
15:00
15:30
15:30
16:15
Networking Break
Modular Approach to Risk Based Qualification
- Knowledge management across an enterprise
- Tools you can use
Seminar Adjourns
16:15
**Please Note that Agendas are Subject to Change**
Veverka
Waters