ISPE
Statistician Forum
Use of Statistics in Support
of the Lifecycle Approach to PV
14 – 15 April 2015
DoubleTree Hotel • Silver Spring, Maryland, USA
Register before 15 March to Save!
Discounted rates apply for groups of three or more.
www.ISPE.org/2015-Statistician-Forum
FDA Leaders Participating
Grace McNally
Alex Viehmann
Senior Policy Advisor
FDA/CDER/OMPT/OC/OMQ/
DPCDO/RPC, Invited
Operations Research Analyst
FDA/CDER/OMPT/OPS/SRS
Karthik Iyer
Senior Product Quality Reviewer
FDA/CDER/OPQ/OPF
Senior Policy Analyst
FDA/CDER/OMPT/CDER/OC/OMQ
Daniel Peng, PhD
Monday, 13 April
NEW! Statistics Primer – Pre-conference Session
Monday, 13 April 2015, 18.00 – 19.30
Process Validation Applicable Statistical Tools, An Overview —
Normality, Intervals, Capability, Sampling Plans (ASTM), and OC Curves
Kim Vukovinsky, Senior Director, Pharmaceutical Science & Manufacturing
Statistics, Pfizer Inc.
Christopher Breen, Senior Research Scientist, Eli Lilly & Co.
Free to registered delegates. Reserve your space when registering.
Tuesday, 14 April
Assuring Analytical Methods to be Appropriate Measuring Devices
Brent Harrington, Senior Principal Statistician, Pfizer Inc.
Setting Specifications for mAbs:
From First Human Dose through PV and Beyond
Alan Richter, AVP, Statistics and Quantitative Sciences, Eli Lilly & Co.
Variability Based Approach to Determining Number of Validation Batches
Maneesha Altekar, PhD, Principal Statistician, AstraZeneca
Selecting the Number of PV Stage 2 Batches: Input Variability Impact
and the Application of Multiple Approaches
Christopher Breen, Senior Research Scientist, Eli Lilly & Co.
Customer Expectations from Statisticians Supporting Manufacturing
Process Validation
David Dolgin, Senior Quality Program Manager, AbbVie Inc.
Wendy Zwolenski-Lambert, Global Validation Leader, Technical Operations, Novartis AG
Sampling Techniques for PV – Devices and Packaging
Tulio Teixeira, Quality Engineering Manager, Bristol-Myers Squibb
Using Process Capability to Ensure Pharmaceutical Product Quality
Daniel Peng, PhD, Senior Product Quality Reviewer, FDA/CDER/OPQ/OPF
Estimating Out of Specification Risks using Process Performance Indices
Abe Germansderfer, Global Manufacturing Science and Technology Lead, Statistics,
Novartis AG
Establishing Content Uniformity Criteria Throughout 3-Stage Validation:
Estimate, Confirm, Control
Kim Vukovinsky, Senior Director, Pharmaceutical Science & Manufacturing Statistics,
Pfizer Inc.
Hear
Hearthe
thelatest
latestFDA
FDAperspective
perspective
and and
discuss
discuss
topics
topics
related
related
to global
to global
expectations,
expectations,
reporting
reporting
of statistically
of statistically
based
based
quality
quality
metrics,
metrics,
establishing
establishing
sampling
sampling
plans
plans
for Process
for Process
Validation
Validation
(PV),(PV),
changes
changes
in blend
in blend
uniformity
uniformity
expectations
expectations
andand
the the
use use
of control
of control
limits.
limits.
Gain
Gain
insights
insights
from
from
andand
interact
interact
withwith
industry
industry
andand
regulatory
regulatory
leaders
leaders
• Examine
• Examine
the merits
the merits
and and
limitations
limitations
of various
of various
statistical
statistical
approaches
approaches
to to
support
support
the lifecycle
the lifecycle
approach
approach
to PV.
to PV.
• Gauge
• Gauge
youryour
company’s
company’s
progress
progress
and and
approaches
approaches
as compared
as compared
with with
others
others
in the
in industry.
the industry.
• Evaluate
• Evaluate
various
various
approaches
approaches
and and
casecase
studies
studies
and and
select
select
or develop
or develop
compliant
compliant
approaches
approaches
which
which
bestbest
applyapply
to the
to specific
the specific
dosage
dosage
formform
typetype
and and
processes
processes
at your
at your
facility.
facility.
• Influence
• Influence
the future
the future
direction
direction
of statistics
of statistics
in PVinthrough
PV through
opportunities
opportunities
for for
further
further
collaboration.
collaboration.
Wednesday,
Wednesday,
1515
April
April
Application
Application
of the
of ASTM
the ASTM
E2709/E2810
E2709/E2810
to the
to Recommendations
the Recommendations
for Assessment
for Assessment
of Blend
of Blend
and and
Content
Content
Uniformity
Uniformity
and and
Tolerance
Tolerance
Interval
Interval
Approach
Approach
for Passing
for Passing
USPUSP
Content
Content
Uniformity
Uniformity
TestTest
James
James
Bergum,
Bergum,
PhD,PhD,
President,
President,
BergumSTATS,
BergumSTATS,
LLC LLC
Recommendations
Recommendations
for the
for Assessment
the Assessment
of Blend
of Blend
and and
Content
Content
Uniformity:
Uniformity:
Modifications
Modifications
to Withdrawn
to Withdrawn
FDAFDA
DraftDraft
Stratified
Stratified
Sampling
Sampling
Guidance
Guidance
Thomas
Thomas
Garcia,
Garcia,
PhD,PhD,
Research
Research
Fellow,
Fellow,
PfizerPfizer
Inc. Inc.
Statistically-Based
Statistically-Based
Sampling
Sampling
Plans
Plans
for PPQ
for PPQ
– An–Implemented
An Implemented
Approach
Approach
Lori Lori
Pfahler,
Pfahler,
Director,
Director,
Merck
Merck
PPQPPQ
Sampling
Sampling
Strategy
Strategy
for afor
Biologic
a Biologic
DrugDrug
Product
Product
Ken Ken
Hinds,
Hinds,
Associate
Associate
Director,
Director,
Janssen
Janssen
R&DR&D
A Pragmatic
A Pragmatic
Approach
Approach
to Stage
to Stage
3 Planning
3 Planning
for New
for New
and and
Legacy
Legacy
Products
Products
Matthew
Matthew
Howard,
Howard,
PhD,PhD,
Global
Global
Technical
Technical
Lead,Lead,
Johnson
Johnson
& Johnson
& Johnson
Utilizing
Utilizing
Statistics
Statistics
to Support
to Support
PV Stage
PV Stage
3b Planning-Baysean
3b Planning-Baysean
Model
Model
Approach
Approach
Kathleen
Kathleen
Giacoletti,
Giacoletti,
Senior
Senior
Statistician,
Statistician,
Arlenda
Arlenda
Inc. Inc.
Statistically
Statistically
Based
Based
Routine
Routine
Release
Release
– Stage
– Stage
3b 3b
JennJenn
Walsh,
Walsh,
Associate
Associate
Director
Director
Technical
Technical
Services,
Services,
Bristol-Myers
Bristol-Myers
Squibb
Squibb
CPVCPV
for Legacy
for Legacy
Products:
Products:
Operational
Operational
Definitions,
Definitions,
StateState
of Control,
of Control,
and and
Confounding
Confounding
James
James
Crichton,
Crichton,
Global
Global
LeadLead
Statistician,
Statistician,
Sandoz
Sandoz
AG AG
FDAFDA
ViewView
of Process
of Process
Monitoring
Monitoring
Expectations
Expectations
& Opportunities
& Opportunities
AlexAlex
Viehmann,
Viehmann,
Operations
Operations
Research
Research
Analyst,
Analyst,
FDA/CDER/OPS/SRS
FDA/CDER/OPS/SRS
ThisThis
conference
conference
is designed
is designed
for experienced
for experienced
statisticians
statisticians
and and
process
process
validation
validation
professionals
professionals
withwith
a considerable
a considerable
working
working
knowledge
knowledge
of statistics.
of statistics.
Presentations
Presentations
will only
will only
cover
cover
the application
the application
of statistical
of statistical
tools.
tools.
Attend
Attend
the Statistics
the Statistics
Primer
Primer
on Monday
on Monday
nightnight
to refresh
to refresh
youryour
understanding
understanding
of the
of the
statistical
statistical
approaches
approaches
presented
presented
during
during
the conference.
the conference.
Agendas
Agendas
and speakers
and speakers
are subject
are subject
to change
to change
without
without
notice.
notice.
EveryEvery
possible
possible
effort effort
will bewill
made
be made
to to
substitute
substitute
a speaker
a speaker
with comparable
with comparable
qualifications.
qualifications.
FDA Keynote Address
Grace McNally
Senior Policy Advisor
FDA/CDER/OMPT/OC/OMQ/DPCDO/RPC, Invited
Implementation Status of the Lifecycle Approach
to PV in Industry and at FDA
Special Sessions
NEW! An Exchange of Views: Stage 1 Batches to be Included
in PPQ Evaluation
Tuesday, 14 April 2015
Hear varied opinions on this controversial topic: Selecting Stage 1 batches to be
included in PPQ; deciding which Stage 1 batches/information can be utilized in
stage 2; determining criteria to progress to stage 2.
NEW! Process Capability – Night Session
Tuesday, 14 April 2015, 18.00 – 19.30
Using Process Capability to Ensure Pharmaceutical Product Quality
Daniel Peng, PhD, Senior Product Quality Reviewer, FDA/CDER/OPQ/OPF
Estimating Out of Specification Risks using Process Performance
Indices
Abe Germansderfer, Global Manufacturing Science and Technology Lead,
Statistics, Novartis AG
NEW! Lessons Learned – Your Company’s Experience Revisited
Tuesday, 14 April 2015
Where does your company stand on the implementation of the Lifecycle
Approach to Process Validation? Which statistical approaches have worked —
which have not. How have they worked for other companies represented at the
conference? Delegates from last year’s conference, along with first time delegates
will be surveyed. Problems and potential solutions will be explored.
NEW! Integrated Case Study
Apply multiple tools at Stages 2 & 3 of the Lifecycle Approach to PV. Presenters
and conference leaders will demonstrate approaches and resulting outcomes
as applied to a unified data set. Compare and contrast results utilizing different
statistical approaches.
Program Committee
Chair: Joanne Barrick, Advisor, Global Validation, Eli Lilly & Co.
Co-Chair: Jenn Walsh, Associate Director Technical Services,
Bristol-Myers Squibb
Members:
James Bergum, PhD, President, BergumSTATS, LLC
Christopher Breen, Senior Research Scientist, Eli Lilly & Co.
Mark Johnson, Principal Research Statistician, AbbVie Inc.
Markus Kiefer, PhD, Head Manufacturing Science & Technology,
Sandoz AG: Global Technical Operations
Tara Scherder, Managing Director, Arlenda Inc.
Kimberly Vukovinsky, Senior Director, Pharm Sci & Manufacturing Statistics,
Pfizer Inc.
Wendy Zwolenski-Lambert, Global Validation Leader, Technical Operations,
Novartis AG
Conference Fees
and Registration Information
TYPE
ON OR
BEFORE
1 MAR
ON OR
BEFORE
15 MAR
AFTER
15 MAR
Member
US $999
US $1,545
US $1,745
New Member*
US $1,278
US $1,824
US $2,024
Nonmember
US $1,915
US $1,915
US $2,125
Committee
US $999
US $1,160
US $1,310
Government
US $700
US $700
US $700
Student Member
US $700
US $700
US $700
Academia Member
US $999
US $1,160
US $1,310
*New Member price includes a 1-year membership to ISPE.
GROUP
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How to Register
The program is designed for experienced statisticians and process validation professionals with
a considerable working knowledge of statistics.
Online: www.ispe.org/2015-Statistician-Forum
Via Fax: Complete the registration form online and fax it to: +1-813-264-2816.
Via Mail: Complete the registration form online and mail it with payment to:
For room reservations,
call +1-301-589-5200. When
making your reservation by
phone, mention ISPE for the
discounted rate of US$179
single/double. This rate is good
until 23 March 2015, or until the
room block is full, whichever
comes first. Please contact the
hotel as early as possible to
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DoubleTree Silver Spring as this enables ISPE to meet contract
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5
TEL: +1-301-589-5200
DoubleTree Hotel
Silver Spring, Maryland, USA
DoubleTree by Hilton
8727 Colesville Road
Silver Spring, Maryland
20910
USA
14 – 15 April 2015
Hotel Information
Use of Statistics in Support
of the Lifecycle Approach to PV
Cancellations must be made in writing. If cancellations are received by 15 March 2015,
a full refund, minus a $100 handling fee, will be issued. After that time, no refunds will be
granted. If you are unable to attend, substitutions will be accepted. However, nonmembers
substituting for a Member must pay difference in fees prior to the start of the event. ISPE is
not responsible for lost airfare due to cancellations.
www.ISPE.org/2015-Statistician-Forum
Cancellations and Substitutions
Discounted rates apply for groups of three or more.
ISPE Statistician Forum
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Questions? Call ISPE at tel +1-813-960-2105, or email: ask@ispe.org.
For more information visit www.ispe.org/2015-Statistician-Forum.
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Register before 15 March 2015 to Save!
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