Large Brochure

Launching at this
Year’s Annual Meeting!
Be the First to See it, Discuss it, and Use it!
Take advantage of this year’s
multi-faceted program!
2thought-provoking
keynote presentations
4training courses
Join ISPE
in Philadelphia, Pennsylvania— 6dynamic education tracks
9exciting social events
One of North America’s
leading pharmaceutical
engineering centers!
5 Schedule at a Glance
6 Keynote Sessions
7 Exhibit Hall
8-9 Educational Topics
10-11 Education Schedule
70+comprehensive
14-16 Training
225+exhibitors
1,600+attendees
Countless
4 Highlights
20global regulators
education sessions
Contents
networking opportunities
17 General and Hotel Information
18-19 Expanding Networks
20 Registration
ISPE Drug Shortage
Assessment and
Prevention Tool
Take Drug Shortages Prevention
from Theory to Practice
Easy-To-Use Tool for Self-Assessment
and Continual Improvement
Increase Supply Reliability
The tool is designed to help industry mitigate supply
chain problems, prevent negative impacts of shortages
on patients, and identify gaps in manufacturing
production and quality systems.
Only ISPE Members and Conference Attendees
will have access to this complimentary resource!
Monday, 9 November, 10.45 – 12.15
Business Continuity Planning for the Prevention
of Drug Shortages: Introducing the ISPE Drug
Shortage Assessment and Prevention Tool
21 Onsite Services
See page 18 for a list of these opportunities
2
ISPE Annual Meeting 2015
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3
Annual
Meeting Highlights
Featured Sessions
Latest Trends from FDA in
Compliance, Enforcement,
cGMPs and Quality Systems
Baxter’s Integrated Plasma
Protein Manufacturing Facility:
The Home Stretch
Opening Keynote Session
ISPE leaders and featured speakers kick off this
year’s meeting by addressing your top concerns.
Sponsored by:
Kathryn Wengel
Vice President
Johnson & Johnson Supply Chain
Quality as a Competitive Advantage
in Supply Chain
Successful Delivery of a Large-Scale
Pharmaceutical Facility in China
Asia-Pacific GMP Update and Outlook
• Innovative Technologies in China
• Implementation Challenges
and Solutions
Asia-Pacific Sessions Sponsored by:
John G. Cox
Executive Vice President
Pharmaceutical Operations and Technology
Biogen
Transforming Biologics Manufacturing
to Deliver on a Global Biopharmaceutical
Pipeline: Biogen’s Strategy for
Success through Innovation
2015 FOYA Winners’ Presentations
Program
Sponsored by:
Updated Sessions and Case Studies
Along with Data Integrity, Process
Capability & Validation, Quality
Metrics, Drug Shortages, Single-Use
Technologies, Barrier and Aseptic
Systems, Breakthrough Therapy, Risk
Management, Continuous Processing
and Clinical-Phase Products, Patients
and Technologies
4
ISPE Annual Meeting 2015
Global Regulatory Town Hall
International and US FDA regulators weigh in on the biggest
challenges facing the industry: harmonization, data integrity
and quality risk management. Be there to lend your voice to
the discussion.
Innovation Forum
Interactive sessions focus on unique projects, technologies
and approaches that clearly demonstrate how companies
have successfully adopted innovation as a benefit rather
than as a risk. Does your organization foster a culture that
supports innovation?
Schedule at a Glance
Visit the website for the most updated schedule: www.ISPE.org/2015-Annual-Meeting
SUNDAY, 8 NOVEMBER
TUESDAY, 10 NOVEMBER
08.30 – 09.30
Student Poster Competition Set-Up
0 7. 3 0 – 07.45
Young Professionals
Meet and Greet
12 . 3 0 – 13.30
Young Professionals/Student
Luncheon and Orientation
08.0 0 – 10.00
Membership Breakfast and Awards
10 .0 0 – 10.45
Networking Break in the Exhibit Hall
10 . 4 5 – 12.15
Education Sessions
12 .15 – 13.30
Lunch in the Exhibit Hall
13 . 3 0 – 15.00
Education Sessions
15 .0 0 – 16.00
Networking Break in the Exhibit Hall
16 .0 0 – 17.30
Education Sessions
19. 0 0 – 22.00
Tuesday Night Party at Reading
Terminal Market
15 .0 0 – 17.00
Opening Keynote Session with Kathryn
Wengel and John Cox
17. 0 0 – 19.00
Welcome Reception in the Exhibit Hall
MONDAY, 9 NOVEMBER
0 7. 0 0 – 08.00
7th Annual ISPE Charity 5k Run/Walk
0 7.15 – 08.15
New Member and First-Time Attendee
Orientation and Networking Breakfast
0 8 .15 – 08.30
Young Professionals
Meet and Greet
08.30 – 10.00
Facility of the Year (FOYA) 2015
Category Winners Education Session
08.30 – 10.00
Education Sessions
10 .0 0 – 10.45
Networking Break in the Exhibit Hall
10 . 4 5 – 12.15
Education Sessions
12 .15 – 13.30
Lunch in the Exhibit Hall
13 . 3 0 – 15.00
Education Sessions
13 . 3 0 – 17.00
International Student Poster Competition
15 .0 0 – 16.00
Networking Break in the Exhibit Hall
16 .0 0 – 17.30
Global Regulatory Town Hall
17. 3 0 – 18.30
Mix and Mingle Reception
in the Exhibit Hall
19. 3 0 – 22.00
Young Professionals Event
at Lucky Strike
WEDNESDAY, 11 NOVEMBER
08.30 – 10.00
Education Sessions
10 .0 0 – 10.30
Networking Break
10. 3 0 – 12.00
Education Sessions
Facility Tours
0 9.0 0 – 20.00
Facility Tour III
AstraZeneca’s New Formulation Suite
0 9.40 – 20.00
Facility Tour II
Morphotek’s 2013 Sustainability Facility
of the Year Category Winner
10 .0 0 – 16.00
Facility Tour I
Merck’s Gardasil Vaccine
Production Facility
Sessions marked (Y) are sessions that may be of interest to
Young Professional and Student members.
Times Subject to Change
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5
Exhibit Hall
Exchanging Ideas
Keynote Sessions
Kathryn Wengel
Vice President
Johnson & Johnson Supply Chain
Ms. Wengel serves on the
Johnson & Johnson Management
Committee and chairs the
JJSC Leadership Team. She
is also a Johnson & Johnson leadership member
of the Regulatory Compliance and Government
Affairs Committee and the Science, Technology
and Sustainability Committee of the Johnson &
Johnson Board of Directors. Ms. Wengel has
enterprise leadership responsibility for all aspects
of Supply Chain, including accelerating Johnson &
Johnson’s innovation and growth objectives, building
and leveraging capabilities that meet the diverse
needs of the business, and enabling the delivery
of a reliable supply of high-quality products and
services to customers around the world.
John G. Cox
Executive Vice President
Pharmaceutical Operations
and Technology
Biogen
Mr. Cox oversees Biogen’s
production facilities, supply chain
operations, technical development, quality and
engineering around the globe. Mr. Cox brings more
than 20 years of experience in biopharmaceuticals
with roles of increasing responsibility at Biogen
Idec. He has led the operations of two world‑class
biopharmaceutical manufacturing facilities,
and has overseen small‑scale cell culture and
purification laboratories, along with the start‑up
of a pilot facility. Additionally, Mr. Cox held a
number of senior roles at Diosynth, Inc. and Wyeth
Corporation, where he worked in technology
transfer, validation and purification.
Facility of the Year Awards (FOYA)
Education Session
MONDAY, 9 NOVEMBER
Program sponsored by:
6
ISPE Annual Meeting 2015
Overall Winner to be announced during the Membership Breakfast and Awards
Learn about the innovative projects from the 2015 Facility of the Year Awards Category
Winners. The FOYA Program recognizes state-of-the-art pharmaceutical manufacturing
projects utilizing new and innovative technologies to improve product quality, reduce
cost and demonstrate advances in project delivery.
Give your company the leading edge
With more than 1,600 pharmaceutical professionals
in attendance each year, ISPE Annual Meeting
brings together industry leaders and decision
makers eager to see the latest technology and
innovative solutions for their businesses.
By sponsoring or exhibiting at the event, you will
gain recognition and the opportunity to develop
relationships with leading industry professionals.
Don’t miss the chance to reserve your space and
take advantage of the many sponsorship opportunities
before they sell out.
A limited number of exhibit spaces and sponsorships
are still available. For more information, contact Alisa
Pachella, Account Manager at [email protected] or
+1-813-739-2274.
Exhibit Hall Giveaways
Visit identified Exhibit Hall Giveaway Sponsors’ Table
Top Exhibits and have your entry card stamped.
Drop your completed card into the drawing tumbler
for a chance to win one of several prizes.
Must be present to win. Only registered education
or training attendees are eligible.
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Exhibit Hall Hours
SUNDAY, 8 NOVEMBER
17.00 – 19.00
Exhibitor Set-Up
08.00 – 16.00
Exhibit Hall Opens
with the Welcome Reception
17.00 – 19.00
MONDAY, 9 NOVEMBER
09.30 – 18.30
Networking Break in the Exhibit Hall
10.00 – 10.45
Lunch Served in the Exhibit Hall
12.15 – 13.30
Networking Break in the Exhibit Hall
15.00 – 16.00
Mix & Mingle Reception in the Exhibit Hall 17.30 – 18.30
TUESDAY, 10 NOVEMBER
09.30 – 16.00
Networking Break in the Exhibit Hall
10.00 – 10.45
Lunch in the Exhibit Hall
12.15 – 13.30
Networking Break in the Exhibit Hall
15.00 – 16.00
Exhibitor Move-out Begins
16.15
Exhibit Hall Walk-through Passes are not available.
www.ISPE.org/2015-Annual-Meeting
7
Go to the website for full list of sessions, descriptions and a speaker list.
www.ISPE.org/2015-Annual-Meeting/Learn
Educational Topics
End-to-End Supply Chain Management
Information Systems
Experience practical applications and real-world
insights from industry leaders as they share
their knowledge and experience as it relates to
clinical sites and patient usage. Hear from US
and EU regulators, patients and special guests
from the US Customs and Border Protection.
Information systems technology and approaches
continue to rapidly evolve. This constant
change has caused increased application
and utilization, which in turn has created
additional challenges, new expectations, and
heightened scrutiny from regulatory agencies
worldwide. Gain a heightened understanding
of current trends in information systems that
impact our industry’s regulatory landscape.
SELECTED SESSION TOPICS:
• Patient Testimonials from Clinical Trials
• Customs and Border Patrol
• Counterfeit Medicines
• eLabels
Facilities and Equipment
Product Development and Production Systems
Gain a better understanding of the challenges
presented to owners/users throughout the global
biopharmaceutical industry. Learn how to confront
diverse issues affecting facility design, construction
and operation, and how to utilize innovations
in processing technology, such as single‑use
manufacturing equipment and techniques.
• Sustainable Development/Sustainability
Explore lessons learned surrounding the challenges
of Single‑Use, Continuous Processing, Aseptic and
Barrier Isolator technologies. Prepare to deal with
the significant containment issues related to the new
class of products – Antibody Drug Conjugates. Learn
to recognize capacity improvement opportunities
and re-think your established processing of Oral
Solid Dosage products. Discover new approaches
for effective delivery of complex Commissioning
and Qualification requirements and strategies for
successful product launches.
• Risk-Based Qualification for the 21st Century
SELECTED SESSION TOPICS:
• Implementing Single-Use Technology
• Product Launches
• Upgrading/Decommissioning of Existing Facilities
• Continuous Processing
SELECTED SESSION TOPICS:
• Critical Utilities Optimization
• Commissioning and Qualification
• Workflows and New Technologies
• Next Generation Manufacturing
• Policy Influence on the Supply Chain
ISPE Annual Meeting 2015
• Data Integrity
• R&D/Clinical Systems
• Regulated Mobile Applications
• Serialization/Track and Trace
Regulatory Compliance and Quality Systems
Hear from global regulators regarding the
changes facing their organizations and how those
changes will impact your company. From the
perspectives of FDA, EMA, MHRA and PMDA, gain
an understanding of how emerging regulations,
developing guidance and new enforcement
practices may alter your strategies for assuring
product quality with an eye toward efficiency.
SELECTED SESSION TOPICS:
• Quality Metrics
• Preventing Drug Shortages
• International Regulatory Updates
• Breakthrough Therapy
• Data Integrity
• Cloud Computing
NEW this Year!
Innovation Forum
Novel and unique ideas on how our highly regulated
and competitive industry can adopt innovation as a
benefit—and not as a risk—will be the focus of the
Forum. Learn through case studies, discussions,
workshops and roundtables how to foster a culture
that supports innovation within your own organization.
SELECTED SESSION TOPICS:
• Behavior of Your Workforce
• Hybrid Facilities
• Project Capital Efficiency
• Innovative Project Execution in China
• Implementing New Systems
Go to the website for full list of sessions, descriptions and a speaker list.
www.ISPE.org/2015-Annual-Meeting/Learn
8
SELECTED SESSION TOPICS:
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9
Education Schedule
New Directions in Continuous Process
for MAb Manufacturing
15.00 - 17.00 Opening Keynote Session
Hot Topics in Validation - Part 2
17.00 - 19.00 Welcome Reception in Exhibit Hall
Single-Use Standardization Update
– An Interactive Panel Discussion
Biomanufacturing Facility Capacity Improvement
Using Process Modelling
Innovation Forum:
Part 1 - Rapid Deployment Modular OSD Unit
Operations; Part 2 - Hybrid Facilities
16.00 - 17.30
17.30 - 18.30 Mix and Mingle Reception in the Exhibit Hall
Lessons Learned from Implementing Single-Use
Technology
Tuesday, 10 November
Pragmatic Approaches to Data Integrity - Part 1
08.00 - 10.00 Membership Breakfast and Awards
Patient Perceptions of Investigational Medicinal
Products from 2015 Survey Results with Real
World Applications from Takeda
10.00 - 10.45 Networking Break in the Exhibit Hall
Innovation Forum: The Future of Pharma
Manufacturing – The Next 100 Years
Implementing Single-Use Technology
for Biomanufacturing
10.00 - 10.45 Networking Break In the Exhibit Hall
Cross Contamination: Dedication, Segregation
or Other?
Case Study of 12 Flexible Facility Biopharm Projects
10.45 - 12.00
Hot Topics in Validation - Part 1
Business Continuity Planning/ISPE Drug Shortage
Assessment and Prevention Tool
10.45 - 12.15
A Decade of Data – Facility of the Year (FOYA)
Aggregate Metrics
Adoption of Quality Risk Management Principles
in Breakthrough Therapy
Successful Product Launches
Impact of Single-Use Manufacturing on Process
Development
Specialized eClinical Solutions for Clinical
Trial Processes
Current Trends in Barrier and Aseptic Technologies
Pragmatic Approaches to Data Integrity - Part 2
Part 1 - Customs and Border Protection (CBP)
and Roundtable; Part 2 - How Trade Regulations
and Policy Influence the Supply Chain
Part 1 - Turning the Page from Patient Unfriendly
to Patient Friendly; Part 2 - Monitoring and
Enhancing Compliance in Clinical Trials
Innovation Forum:
Part 1 - IT Roadmap for 21st Century and Beyond;
Part 2 - Preventing and Governing Orphan Data
Innovation Forum: Moving Beyond Paradigm
Paralysis
12.15 - 13.30 Lunch in the Exhibit Hall
Biomanufacturing: The Convergence of Continuous
Processing and Single-Use Technology
GMP in Aging Facilities and Upgrade
of Existing Facilities
The Latest OSD Regulation Requirements
and Technologies for Pharma Operations
Baxter Integrated Plasma Protein Manufacturing
Facility: The Home Stretch
ISPE Annual Meeting 2015
13.30 - 15.00
12.15 - 13.30 Lunch in the Exhibit Hall
13.30 - 15.00
Process Capability for Continuous Improvement
- Part 1
Effective Integration of Environmental Health and
Safety Requirements into Project Design Review
Part 1 - Counterfeit Medicines;
Part 2 - Current Status and Trends on Serialization
and Track & Trace
Applying Risk-Based Validation to Move to an
ASTM E2500
Advances in Next Generation Manufacturing
HVAC Sustainability
International Regulatory Updates
C&Q Project Management – The Ultimate Challenge!
The Challenge of IT Infrastructure
Part 1 - Round Table on Counterfeit Medicines;
Part 2 - Regulatory Challenges with the EU
(Annex 6);
Part 3 - Metrics for Clinical Trials
Innovation Forum:
Part 1 - Innovative Process for Expeditious
Preparation of Capital Appropriation Packages for
the BioPharm Industry;
Part 2 - A New Approach to Improve Major
Pharmaceutical Project Capital Efficiency
Improving Your Interactions with Cloud Providers
Current Status and Trends on Serialization and
Track & Trace - Part 1
Innovation Forum: Achieving Innovation in
Science Facilities Design – Providing High Value,
Innovative Design and Delivery Strategies with
Fixed Project Constraints
Case Studies in Suspect Product Notification
Reporting
Development Workflows and Emerging
Technologies in Continuous Processing
PAT in Raw Materials
Part 1 - Real World Experiences with E-labeling;
Part 2 - English Only on Primary Packs and
E-labels;
Part 3 - Transcelate Update on E-labeling
Decommissioning Pharmaceutical Equipment
and Facilities
19.30 - 22.00 Young Professionals Event at Lucky Strike
Critical Utilities Maintenance Program
and Operational Optimization
Quality Metrics - Part 1
15.00 - 16.00 Networking Break in the Exhibit Hall
Global Regulatory Town Hall
Latest Trends from the FDA in Compliance,
Enforcement, cGMPS and Quality Systems, and
Industry’s Perspective and Challenges
Clinical Data Archiving and eTMF Migration
Case Study
Innovation Forum:
Part 1 - Asia-Pacific GMP Update & Outlook;
Part 2 - Innovative Technologies in China
16.00 - 17.30
08.30 - 10.00
Combination Products: Same Vocabulary, Different
Interpretation
15.00 - 16.00 Networking Break in the Exhibit Hall
Risk-Based Qualification – 10 Years After the
Landmark ISPE White Paper on Risk-Based
Qualification for the 21st Century
08.30 - 10.00
Managing Abstract Elements Beyond Facilities
Facility of the Year (FOYA) 2015 Category Winners
Education Session
Part 1 - Patient Testimonials from Clinical Trials
Part 2 - Clinical Supplies and Investigator Site
Wednesday, 11 November
09.00 - 20.00 Facility Tour III - AstraZeneca
09.40 - 20.00 Facility Tour II - Morphotek
10.00 - 16.00 Facility Tour I - Merck
10.00 - 10.30 Networking Break
Facing the China Challenge – An Interactive
Workshop on Construction Projects in China
Quality Metrics - Part 2
19.00 - 22.00 Tuesday Night Party at Reading Terminal Market
End-to-End Product Risk Management
Antibody Drug Conjugates – An Opportunity and
a Challenge
Tracks Color Key
Networking, Lunch, Tours
Facilities and Equipment Track
Regulatory Compliance and Quality Systems Track
Product Development and Production Systems Track
Information Systems Track
FDA Update from the Office of Pharmaceutical
Quality
End-to-End Supply Chain Management Track
Process Capability for Continuous Improvement
- Part 2
Innovation Forum Track
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10.30 - 12.00
07.15 - 08.15 New Member and First-Time Attendee Breakfast
Compliant Regulated Mobile Applications
13.30 - 15.00
Current Data Integrity Trends
– A Regulatory and Compliance Perspective
13.30 - 15.00
Sunday, 8 November
Monday, 9 November
10
Times Subject to Change
Drug Shortages Prevention Plan – Best Practices
and Case Studies
Single-Use Technology – The Advances of a
Flexible Technology in a Structured Environment
Current Status and Trends on Serialization and
Track & Trace - Part 2
Early Access to Investigational Medicines
Innovation Forum:
Part 1 - Resisting Temptation – A Unique
Approach to Implementing New Pharmaceutical
Systems;
Part 2 - Case Study: Resolving a Legacy Product
Quality Issue through Application of Process
Understanding and Design of Experiments
www.ISPE.org/2015-Annual-Meeting
11
FRESH THINKING, BETTER OUTCOMES
MAKING THE COMPLEX
ELEGANT
ENGINEERING | COMPLIANCE | COMMISSIONING | LEADERSHIP
• Chemicals/Manufacturing/Controls
(CMC)
THE PHARMATECH DIFFERENCE
• Analytical Methods and Validation
Staffed by industry experts, Pharmatech Associates provides consulting
and services to the regulated life science industry. Pharmatech’s services
cover four spheres of technical expertise that are necessary throughout
the complete product development lifecycle: Product and Process
Development, Compliance, Regulatory, and Validation. Pharmatech
advises clients that range in size from startups to large multi-national
corporations on projects in Asia, Europe and North America from its
headquarters in the San Francisco Bay Area.
• Tech Transfer, Scale Up,
Trouble-shooting
• Quality Management Systems
• Pre-Approval Preparation
& Readiness
• Acquisition/Partnering Due Diligence
• Quality Risk Management
• Commissioning&Qualification
• Compliance Remediation
Mechanical | Electrical | Plumbing | Fire Protection | Process Utilities | Automation
Central Utilities | Critical Environments | CFD Modeling | Energy Optimization | Sustainability
Ambler, PA
215.540.9800
www.precisengineering.com
PRECISION
• Operational Excellence
Compliance Through Science ®
P: 1.510.732.0177 F: 1.510.732.1992 Toll Free: 1.877.787.0177
[email protected] | www.pharmatechassociates.com
ENGINEERING
FOR
PERFORMANCE
Visit our exhibit at
the annual meeting
CRITICAL
connect with us
FACILITIES
Training
See page 16 for Training Course registration and pricing.
MONDAY, 9 NOVEMBER – TUESDAY, 10 NOVEMBER
Managing the Risk of CrossContamination: Applying the
Risk‑MaPP Baseline® Guide (T41)
Instructor: Stephanie Wilkins, PE, President,
PharmaConsult US
Do you need strategies to safely manufacture your
high-hazard products in multiproduct facilities?
Know how to use quality risk management processes
to determine the extent of technical measures required
to control the risk of cross-contamination. This
course outlines a method for you to prepare Quality
Risk Management plans based on ICH Q9, using
health‑based exposure limits to provide manufacturers
with tools to reap the benefits of lower costs and
higher efficiency while maintaining product quality
and patient safety.
Immediately apply the course learning
objectives using the complimentary
copy of the ISPE Baseline Guide:
Volume 7 Risk-Based Manufacture of
Pharmaceutical Products (Risk-MaPP).
A GAMP® Approach to Data Integrity, Electronic Records and Signatures,
and Operation of GxP Computerized Systems (T50) — New course!
(Individual Download)
Instructor: Sion Wyn, Director, Conformity Ltd
Turning QbD into a
Practical Reality (T43) Do you know how to use QbD to reduce costs,
improve manufacturing and meet regulatory
expectations?
This interactive course uses group exercises to
provide examples of how products and processes
can be developed using QbD with an emphasis on
the considerations for implementing these processes
in manufacturing. Topics include: understanding the
principles of a science- and risk-based approach;
product and process understanding and patient
requirements; implications of relevant ICH, EMA,
ASTM E2500, and FDA Guidelines; QRM tools (FMEA,
risk ranking); applying FMEA to Control Strategy
selection; the relationship between PQS and GMP
and how they link to Control Strategy; considerations
when implementing a control strategy derived from
enhanced QbD approaches; and opportunities for
continual improvement arising from application of
statistical techniques.
Immediately apply the course learning
objectives using the complimentary
copy of the ISPE PQLI® Guide Series:
Part 1 – Product Realization using
Quality by Design (QbD): Concepts
and Principles and Part 2 – Product
Realization using Quality by Design
(QbD): Illustrative Example.
Can your data integrity process stand up to regulatory scrutiny?
Data integrity is currently one of the highest cited
areas in regulatory observations, and a topic of great
interest within the industry and for regulatory agencies
that are re-evaluating industry guidance and their
enforcement strategies. This course will cover data
integrity, electronic records and signatures, and the
compliant operation of GxP Computerized Systems to
provide the tools and techniques to implement proper
controls for data, and ensure the integrity and validity
of information throughout the data lifecycle.
14
ISPE Annual Meeting 2015
Immediately apply the course learning
objectives with a complimentary bound copy
of the GAMP® 5: A Risk‑Based Approach to
Compliant GxP Computerized Systems Guide
and an individual download of the GAMP Good
Practice Guide: A Risk-Based Approach to
Compliant Electronic Records and Signatures.
See page 16 for Training Course registration and pricing.
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15
Training
General and Hotel Information
MONDAY, 9 NOVEMBER – TUESDAY, 10 NOVEMBER
Practical Application
of Technology Transfer (T19)
Instructor: Bruce Davis, Principal, Global Consulting
Does your technology transfer reflect an enhanced
approach to current best practices?
Technology Transfer (TT) includes knowledge transfer,
science and risk-based principles including ICH
Q8, Q9, Q10, Q11 and efficient processes to meet
evolving business needs. As the industry continues
to experience changes, technology transfer for active
pharmaceutical ingredients (APIs), finished dosage
forms and analytical methods between development
and manufacturing sites and contract manufacturing
organizations (CMOs) have become increasingly
important. This course identifies criteria for successful
TT and provides ‘how to’ examples which can be
individually tailored depending on the type and scope
of transfer. It takes into account current industry
challenges and real-world examples as tools for
industry professionals and regulators to use when
conducting and evaluating TT activities.
Immediately apply the course learning
objectives using the complimentary
copy of the ISPE Good Practice Guide:
Technology Transfer (Second Edition).
Risk-MaPP and QbD Course Fees
TYPE
Member
ON OR BEFORE
11 OCTOBER
US $1,800
AFTER
11 OCTOBER
US $2,000
ISPE Annual Meeting 2015
Cancellation Policy
1201 Market Street
Philadelphia, PA 19107
Tel: +1-215-625-2900
Guests canceling their stay less than 72 hours prior to
the day of check-in will be charged for their full stay.
Registration +
Membership*
US $2,079
US $2,279
Check-in: 16.00
Check-out:12.00
Nonmember
US $2,186
US $2,396
Reservations
Government
US $ 900
US $ 900
GAMP® and Tech Transfer Course Fees
TYPE
ON OR BEFORE
11 OCTOBER
AFTER
11 OCTOBER
Member
US $1,700
US $1,900
Registration +
Membership*
US $1,979
US $2,179
Nonmember
US $2,081
US $2,291
Government
US $ 850
US $ 850
*Fee includes one-year ISPE membership.
Training course registration includes course materials,
break and lunches. Hotel accommodations, hotel fees
and a la carte events are separate from registration
fees. Registration is confirmed only when payment is
received. Annual Meeting registration does not include
training courses.
16
Philadelphia Marriott Downtown
ISPE rate: US$249 single/double
Once you have registered for the event online, you will
see your personal reservation link on the order detail
page to make your hotel reservation. Your registration
confirmation letter will also have your reservation link.
Be sure to make your hotel reservation immediately
to ensure a room at the Marriott. Changes can be
made online by following the directions in your hotel
acknowledgment email.
On 14 October, ISPE will transfer the reservations to
the hotel. Rest assured your room is reserved once
you make your reservation through ISPE. The hotel will
send out confirmations by email after 14 October.
Nonrefundable Deposit
Please note that if you do not arrive on the first
day of your room reservation, the hotel will charge
you a no‑show fee equal to one night and may not
have a hotel room available when you arrive. Please
remember to contact the hotel if you are delayed.
Upgrades
After you have made your hotel reservation
through ISPE, you can contact Althea Morgan
([email protected]) to ask about room
upgrade options.
Amenities
• Complimentary in-room Internet for ISPE attendees
• 25% discount on overnight valet parking
• 24-hour access to fitness center
Airport Information
Philadelphia International Airport
10 mi /16 km to hotel
A deposit of one night is required to hold your
room reservation and is nonrefundable after
14 October. Credit cards will be charged one night
as of 15 October. Please complete the credit card
information in full to have a guaranteed reservation.
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17
Expanding Networks
Facility Tours Plus Philadelphia Excursions
WEDNESDAY, 11 NOVEMBER 2015
Includes: transportation, tours and lunch
All tours depart from Philadelphia Marriott Downtown.
Register early. Space is limited. See more details on the website.
Membership and Awards Breakfast
TUESDAY, 10 NOVEMBER 2015
08.00 – 10.00
US$45 (Included in Full and Tuesday-Only
Registrations)
Join ISPE leadership and colleagues
for breakfast as we look back on 2015
and recognize significant achievements.
Celebrate with your colleagues as the
2015 Facility of the Year (FOYA) Overall
Winner and ISPE International Honor
Awards are presented.
Annual Meeting networking opportunities provide the easiest
way to expand your professional contacts and build important
and lasting ties to leaders in your field.
Welcome Reception
SUNDAY, 8 NOVEMBER 2015
17.00 – 19.00
Exhibit Hall, Philadelphia Marriott Downtown
US$50 (Included with Full Registration Only)
Sponsored by:
delivering excellence
7th Annual 5K Charity Run/Walk
MONDAY, 9 NOVEMBER 2015
06.30 (Start time 07.00)
Buses depart at 06.30 from hotel lobby
US$25
Start the day with a run/walk by scenic Boathouse
Row along the Schuylkill River. Proceeds benefit the
Center for Information & Study on Clinical Research
Participation (CISCRP).
Sponsored by:
18
ISPE Annual Meeting 2015
Tour I
Merck’s Gardasil Vaccine
Production Facility
10.00 – 16.00
$50
• Tour Independence Hall
• Tour Merck’s Gardasil Vaccine Production Facility
• Lunch (included)
• Tour of Valley Forge
Sponsored by:
Tour II
Morphotek’s 2013
Sustainability Facility of
the Year Category Winner
09.40 – 20.00
Philadelphia Marriott Downtown
Tuesday Night Party
$85
• Tour Independence Hall
• Tour Morphotek’s Sustainable Facility of the Year
• Lunch (included)
• Tour Longwood Gardens
• Dinner at Victory Brewery (included)
For new ISPE Members and First-Time Annual
Meeting attendees only (Included in Full and
Monday‑Only Registrations)
TUESDAY, 10 NOVEMBER 2015
19.00 – 22.00
(Meet in the lobby by 18.45 to network and walk
over to the party with the Mummers)
New Member/First-Time
Attendee Orientation
MONDAY, 9 NOVEMBER
07.15 – 08.15
New to ISPE? Is this your first ISPE Annual Meeting?
Find out how to make the most of your Annual Meeting
experience and ISPE membership while you enjoy a
continental breakfast. Bring your business cards. You’ll
quickly build your lifelong professional network with
one of our most popular events: Speed Networking.
Young Professionals Networking Event
MONDAY, 9 NOVEMBER 2015
19.30 – 22.00
Lucky Strike
US$58
Get ready for a fun networking event that can bring
out your competitive spirit. Bowling, shoes, food and
soft drinks are included. Hosted by ISPE’s Young
Professionals. (Cash bar)
Reading Terminal Market
US$200 (Included with Full Registration Only)
Experience a Taste of the Terminal with a wide variety
of delicious cuisines and Philadelphia favorites on the
menu! Reading Terminal is a 123-year-old historic
building located in the heart of Philadelphia. On the
list of Top 10 places to visit in America, Reading
Terminal hosts mouth-watering aromas, locally
grown and exotic produce, fresh meats, seafood and
poultry, baked goods straight from the oven, AND
the widest variety of restaurants under one roof! The
night will be full of networking, entertainment by the
famous Philadelphia Mummers—and for the first
time, get ready to rock with an ISPE Member band.
Tour III
AstraZeneca’s Newark Facility
Transformation Project
09.00 – 20.00
$85
• Tour Independence Hall
• Tour AstraZeneca’s New Formulation Suite
• Lunch (included)
• Tour Longwood Gardens
• Dinner at Victory Brewery (included)
Sponsored by:
Independence Hall Tour
Longwood Gardens Tour
and Dinner
Merck Tour Bus Sponsor
AstraZeneca Tour Bus Sponsor
Sponsored by:
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19
Registration
Onsite Services
Four Ways to Register
1
Via Online:
Register online www.ISPE.org/2015-Annual-Meeting/Register
2
Via Email:
Complete the registration form, scan and email it to [email protected]
3
Via Fax:
Complete the registration form and fax it to +1-813-264-2816
4
Via Mail:
Complete the registration form and mail it with payment to:
ISPE Headquarters
600 N. Westshore Blvd., Suite 900, Tampa, Florida 33609 USA
Group Discount Rate
Full Education Prices
TYPE
ON OR BEFORE
11 OCTOBER
AFTER
11 OCTOBER
Member
US $1,950
US $2,150
Registration +
Membership*
US $2,230
US $2,430
Nonmember
US $2,330
US $2,530
Committee
US $1,465
US $1,615
Government
US $ 700
US $ 700
Young Professional
Member
US $1,465
US $1,615
Student Member
US $ 200
US $ 200
Academia Member
US $1,465
US $1,615
Bring your team 3 - 5 participants Save 10%
to ISPE Annual 6 -10 participants Save 15%
11 or more participants Save 20%
Meeting
To qualify, all registrant information must be submitted at
the same time; only ONE payment to cover all registrations
will be accepted. Registrations that arrive later will
NOT be eligible for the group discount. To register as a
group, please contact ISPE (tel: +1-813-960-2105).
TYPE
ON OR BEFORE
11 OCTOBER
AFTER
11 OCTOBER
Member
US $ 749
US $ 849
Nonmember
US $ 949
US $1,099
Cancellations must be made in writing. If cancellations are
received by 18 October 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 the difference in fees prior to the start of the event.
ISPE is not responsible for lost airfare due to cancellations.
Exhibit Badge Cancellations
If you are unable to attend, substitutions will be
accepted and will result in a $25 per person change
fee. Payment for the change fee is due at the time
the change is requested and is non-refundable.
Questions?
Tel: +1-813-960-2105
20
ISPE Annual Meeting 2015
Find your next amazing job opportunity or your next great employee
using ISPE Career Solutions. Visit the Career Solutions Hot Jobs booth
to review current job postings and learn about the benefits of posting
your open positions on ISPE’s online job board.
Cancellations and Substitutions
*Includes a 1-year membership to ISPE.
One-Day Prices
(Monday, Tuesday or Wednesday)
Career Solutions (and Hot Jobs!) Find a Job… or a New Employee
ISPE Membership
Show pride in your local
Affiliate or Chapter. Pick
up your Affiliate or Chapter
badge ribbon at the ISPE
Membership display.
ISPE — Membership Has Its Benefits
Did you know that Members get big savings on all of ISPE’s training
programs and events? A “Registration + Membership” bundled
registration fee includes a one-year ISPE Membership.
Visit www.ISPE.org/Membership for details on benefits as well as
discounted dues rates for Young Professionals, Students, Academics,
Regulators and industry professionals from emerging economies.
Thank you to our Program Committee for developing this dynamic event!
Visit www.ISPE.org/2015-Annual-Meeting to learn more about them.
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www.ISPE.org/2015-Annual-Meeting
21
Thank You to Our Sponsors
PINNACLE SPONSOR
PINNACLE SPONSOR
PINNACLE SPONSOR
Badge Sponsor
Independence Hall Tour Sponsor
Keynote Speaker Sponsor
Lanyard Sponsor
Wireless Internet Sponsor
Leadership Reception Sponsor
Tote Bag Insert Sponsor
Host Sponsor
Supporting Sponsor
Refreshment Sponsor
Charity 5k Walk/Run
Sponsor
Exhibit Hall Giveaway
Sponsor
Lunch Sponsor
Lunch Sponsor
Exhibit Hall Giveaway
Sponsor
Membership Breakfast Sponsor
Welcome Reception Sponsor
Longwood Gardens Tour
and Dinner Sponsor
AstraZeneca Tour Bus
Sponsor
Hotel Key Card Sponsor
Exhibit Hall Giveaway
Sponsor
Merck Tour Bus Sponsor
Exhibit Hall Giveaway
Sponsor
Tuesday Night Party Prize
Sponsor
Exhibit Hall Giveaway
Sponsor
Poster Competition Sponsor
Exhibit Hall Giveaway
Sponsor
Exhibit Hall Giveaway
Sponsor
Gold Sponsor
Leadership Reception Sponsor
delivering excellence
Tote Bag Sponsor
Silver Sponsor
FOYA Marquee Sponsor
Tuesday Night Party Sponsor
Silver Sponsor
Exhibit Hall Giveaway Sponsor
Silver Sponsor
Exhibit Hall Giveaway Sponsor
Membership Breakfast Sponsor
Welcome Reception
Sponsor
Exhibit Hall Giveaway Sponsor
22
ISPE Annual Meeting 2015
CONNECT SHARE FOLLOW #ISPEAM15
Membership Breakfast Sponsor
www.ISPE.org/2015-Annual-Meeting
23
ISPE Global Headquarters
600 N. Westshore Blvd., Suite 900
Tampa, Florida 33609-1114 USA
Bring your team to the ISPE Annual Meeting
Group Discount Available 3 - 5 participants Save 10%
See page 20 for more information
6 -10 participants Save 15%
11 or more participants Save 20%
Be Sociable
www.facebook.com/ISPEorg
#ISPEAM15
http://bit.ly/ISPELinkedIn
http://blog.ISPE.org/