PAID
TAMPA, FL
PERMIT NO. 2661
ISPE is launching its first Facilities of the Future Conference Series
featuring Lessons from 483s – Enhancing Efficiency, Quality and cGMP
Compliance. We’ve taken conferences to the next level and have made them
more interactive and topic specific to meet your industry needs.
NON-PROFIT ORG.
U.S. POSTAGE
CONFERENCE OVERVIEW
FACILITIES OF
THE FUTURE
CONFERENCE SERIES
Facilities of
the Future
Conference
Series
Join us as industry leaders and regulators discuss real industry issues on
how to combine the best in science and engineering to deliver low cost
operations and high quality products.
Each track is separated, but will be themed around recent regulatory
citations (FDA-483s) and will provide guidance on how citations could be
prevented. Special Keynote presentations will also address these issues
and relate each track back to the central theme.
Discover how to
combine the best
in science and
engineering to
deliver low-cost
operations and highquality products.
483s CONFERENCE PROGRAM COMMITTEE
Special thanks to the Lessons from 483s Conference Program Committee for their expertise and time in creating this
outstanding professional development opportunity for ISPE.
ISPE Future Visioning Team Liaison
Keynote Speaker
Keynote Speaker
Keynote Speaker
Track Leader: Biotech
Track Leader: Oral Solid Dosage
Track Leader: Process Validation
Subject Matter Expert
Mike Arnold, Pfizer, Inc., USA
Andy Skibo, MedImmune, USA
Michael Lewis, Eisai, USA
Chaz Calitri, Pfizer, USA
Steven Miller, MedImmune, USA; Wendy Lambert, Abbott, USA,
and Andy Skibo, MedImmune, USA
Alan George, ILC Dover, USA and Ray Scherzer, PM SET, LLC, USA
Joanne Barrick, Eli Lilly & Co., USA
Larry Kranking, Coldstream Laboratories, Inc., USA
Lessons
from 483s:
CONFERENCE SCHEDULE AT A GLANCE
Registration will be open from 07.00 – 17.00 on Monday and Tuesday.
Enhancing Efficiency, Quality
and cGMP Compliance
Monday, 27 February
Grand Hyatt Tampa Bay
Tampa, Florida USA
Grand Hyatt Tampa Bay
Tampa, Florida USA
27 – 28 February 2012
For full agenda, visit www.ISPE.org/FacilitiesConference.
Enhancing Efficiency, Quality
and cGMP Compliance
07.00 – 08.30 Continental Breakfast
08.30 – 17.00 Track 1: Biotech
Track 2: Oral Solid Dosage
Track 3: Process Validation
12.00 – 13.00 Lunch
Lessons
from 483s
Tuesday, 28 February
27 – 28 February 2012
600 N. Westshore Blvd. | Suite 900
Tampa, Florida 33609 | USA
07.30 – 08.45 New Member/First-Time Attendee Breakfast
09.00 – 12.00 Keynote Presentations:
M
ichael Lewis, President, Eisai Product Creation Systems, USA
Small Molecule Researcher’s View to Facilities of the Future
A
ndy Skibo, Executive Vice President, MedImmune, USA
Biotech Perspective on Cost-Effective Operations
C
haz Calitri, Vice President, Global Engineering, Pfizer, USA
2020 Vision – the Next Generation of Manufacturing Facilities
12.30 – 13.30 Lunch Break
13.30 – 17.00 Track 1: Biotech
Track 2: Oral Solid Dosage
Track 3: Process Validation
17.00 – 18.30 Evening Reception in Exhibit Hall
ISPE PINNACLE PROGRAMME
2012 Global Sponsor
Sponsorship Opportunities Available
Sponsoring an ISPE educational seminar or training
program is a cost-effective way to gain competitive
advantage, increase name recognition, and create
top-of-mind awareness in today’s pharmaceutical
science and biotechnology manufacturing industry.
Sponsorships include pre-event exposure on the
ISPE website as well as the delegate mailing
list, onsite exposure with exhibit opportunities,
company logo on signage, and mentions in
print and electronic communication. For more
information or to secure your sponsorships,
contact John Phillips at jphillips@ispe.org or
Daniel Murphy at dmurphy@ispe.org.
ORAL SOLID DOSAGE
Learn through case studies and real-life examples from your peers on how to improve the basic processes
of Granulation and Formulation and apply containment to these parts of Oral Solid Dosage manufacturing.
At the conclusion of this session, participants will be able to:
Understand the two components of OSD processing methodology, Granulation and Compression
Process potent and highly hazardous products in a contained manner during these same process steps
Assure product quality levels while eliminating the risk of cross-contamination
Evaluate the risks associated with various strategies
Gain benefits to the life cycle cost of operations, including how reduced energy use can benefit the site’s
profit and loss (P&L) statement
Leaders: A lan E. George, Product Manager, ILC Dover Inc., USA
Ray Scherzer, PM Set, LLC, USA
Paul Egee, Product Manager, IMA North America, USA
Monday, 27 February
BIOTECH
Learn successful approaches and the variety of tools available to drive effective biotech facility utilization
in this uncertain environment.
Whether you are in a strategic planning position or responsible for the tactical execution to deliver on
that strategy, this conference track will provide you with guidance and real-life experience examples from
experts who have tackled these issues.
The tools discussed include use of disposables to allow for rapid changeover and modular plug and play
production lines while conserving or eliminating downtime for cleaning or sterilization.
At the conclusion of this session, participants will be able to:
• Set the right strategies for driving effective biotech facility utilization through the use of a variety of
tools
• A
ddress challenges and take advantage of scientific progress resulting in new products coming to
patients
• S
tay current within the biotechnology industry
• Effectively plan and utilize costly manufacturing assets
Leaders: Wendy Lambert, Director, Pharma Business Support, Abbott Quality & Regulatory, USA
Steven Miller Director, Process Engineering, MedImmune, USA
Andy Skibo, Executive Vice President, MedImmune, USA
Monday, 27 February
Welcome and Review of Agenda
S
teven Miller, Director, Process Engineering,
MedImmune, USA
Regulatory Issues for Multi-Product Facilities
Kip Priesmeyer, FDA, Retired, USA
QbD Impact on Facility Design
TBD
Impact of High Titers
TBD
Use of Modeling
TBD
Tuesday, 28 February
Capacity Sharing
Ben Machielse, Chief Operating Officer
and Executive Vice President, Omthera
Pharmaceuticals, Inc., USA
Virtual Manufacturing Network
Darren Dasburg, MedImmune, USA
Automation Strategy in CIP and SIP
TBD
Disposable Use in Development
David Clark, MedImmune, USA
D
isposables Use in Manufacturing – Case History
TBD
Automation Simulation and Training
Brent Hill, Director of Automation, MedImmune,
USA
MES Applied to Biotech Manufacturing
Roberto Manjarres, Process Control Manager,
Abbott, USA
F DA Regulatory Issues Around Oral Solid Dosage
Manufacturing
Larry Kranking, President & CEO, Coldstream
Laboratories, Inc., USA
S
etting the Stage for Containment in OSD
Processing – Knowing What Questions to Ask and
How Containment Can be Matched to Your Process
John Farris, President & CEO, SafeBridge
Consultants Inc., USA
xamples of Containment Technologies that Have
E
Been Applied to Granulation and Compression
Processes – A 85,000 Foot Overview
Dave DiProspero, Principal of Pharmaceutical
Engineering & Technology, Stantec Consulting
Services, Inc., USA and Paul Egee, Product
Manager, IMA North America, USA
Update and Availability of ISPE SMEPAC Document
George Petroka, Director, BioPharma and EHS, IES
Engineers, USA
Tuesday, 28 February
ranulation Equipment Set Up – Spray Patterns
G
and Powder Flux to Achieve Consistent Particle
Size and Strength
Dave Jones, President, OWI Consulting, USA
Fundamentals of Successful Granulation – Powder
Wetting, Particle Velocity, Granule Strength and
Attrition Problems
Dave Jones, President, OWI Consulting, USA
C
ontained Granulation for Operator Safety, Product
Quality and Elimination of Cross Contamination –
Case Study 1
Kevin Rosenthal, Director of Manufacturing,
Pharmatek Laboratories, USA
C
ontained Granulation for Operator Safety, Product
Quality and Elimination of Cross-Contamination –
Case Study 2
TBD
C
ompression Equipment Troubleshooting and Early
Warning Signs for Detecting Problems
TBD
ompression Equipment Set Up for Improved
C
Operations and Reliability
TBD
F undamentals of Successful Compression – Strong
Enough to Hold Together, Dissolvable, Not Splitting
During Processing
TBD
C
ontained Compression for Operator Safety,
Product Quality and Elimination of Cross
Contamination – Case Study 1
TBD
C
ontained Compression for Operator Safety,
Product Quality and Elimination of CrossContamination – Case Study 2
TBD
C
ontainment Overview Across the Complete OSD
Process
TBD
This workshop will utilize presentations, practical application examples, small group exercises and discussion
forums to bridge the gap between conceptual contemporary expectations for the lifecycle approach to Process
Validation and implementation.
The workshop will include leveraging Process Validation stage 1 (development) information, determining process
validation acceptance criteria, sampling plans, determining the number of batches for Process Validation stage
2, determining an appropriate level of heightened sampling, and testing post Process Validation stage 2 and
managing the Process Validation stage 3 plan.
Attendees will have the chance to discuss, benchmark, and practice application of practical approaches
for satisfying lifecycle Process Validation expectations. You will also be able to hear regulator reactions to
approaches, including strengths and opportunities for improvement, over the course of the workshop session.
At the conclusion of this session, participants will be able to:
•
•
•
•
Gain insight into the practical impacts into the lifecycle approach to PV
Gain clarity around the content of the FDA PV Guidance concepts
Understand approaches and thinking from industry and regulatory leaders
Explain implementation options and status
Leader: Joanne Barrick, Advisor, Global Validation Support, Eli Lilly & Co., USA
Determining a Process Validation Sampling Plan –
Monday, 27 February
Objectives and Structure; Lifecycle Basics, Update
on PDA TR, Interactive Polling/Benchmarking
Questions
Joanne Barrick, Advisor, Global Validation Support,
Eli Lilly & Co., USA
FDA View of Lifecycle Approach Implementation
Status and Application to Legacy Products,
Including 15 Minutes of Q&A
Grace McNally, Consumer Safety Officer, FDA, USA
Expectations/Deliverables from PV Stage 1
(Process Development) Criticality, Design Space
and Control Strategy
John Lepore, Senior Director, Chemical Process
Development and Commercialization,
Merck & Co., USA
Foundation for PV Acceptance Criteria – Applying
Quality Risk Management to Control Strategy
A
nne Renton, Assoc. Quality Consultant, Eli Lilly &
Co., USA
Statistically Based Process Validation Acceptance
Criteria Determination – Including Example
Approaches
Mark Varney, Abbott
Acceptance Criteria Approach – Small Group
Exercise with Whole Group Wrap Up Session
Joanne Barrick, Advisor, Global Validation Support,
Eli Lilly & Co., USA and Facilitators
Tuesday, 28 February
sing Science and Risk Assessment – Control
U
Strategy and Variability Impact on Process
Validation Plan
TBD
Determining a Statistically Based PPQ Sampling
Plan Utilizing ASTM 2907
Jim Bergum, Associate Director, Non-Clinical
Biostatistics, Bristol Myers Squibb, USA
Small Group Exercise and Debrief
Harold Etling, Research Scientist, Eli Lilly & Co.,
USA and Jim Bergum, Associate Director, NonClinical Biostatistics, Bristol Myers Squibb, USA
Determining the Number of Process Validation
Batches – General Considerations and an Example
Approach, Based on ISPE Process Validation
Subteam Work. Making the Batch Release Decision
Based on Stage 1 and Stage 2 Data
Peter Levy, Principal, PL Consulting, LLC, USA
Determining
the Number of Process Validation
Batches – Small Group Exercise and Discussion
TBD
Exercise Debrief and Discussion with Large Group
Harold Etling, Research Scientist, Eli Lilly & Co.,
USA
Stage 3 – Post Process Validation Monitoring –
ISPE Subteam
Kurtis Epp, Senior Manager of Manufacturing,
BioTechLogic, Inc., USA
Small Group Exercise – Determining a Monitoring
Plan Post Process Validation Execution and/or
When to Switch to Routine Sampling and Testing
Harold Etling, Research Scientist, Eli Lilly & Co.,
USA and Jim Bergum, Associate Director, NonClinical Biostatistics, Bristol Myers Squibb, USA
M
anaging the Post Process Validation Plan and
Incorporation in Quality Systems. Turing Off and On
Heightened Monitoring
Joe Famulare, Senior Director, Genentech Inc., USA
Breakout Sessions – What are Remaining Issues
and Challenges?
Breakout Session Summaries and Panel Response
ISPE – Membership Has its Benefits - Did you know that ISPE
Members attend training programs and other events at discounted rates? New
Member registration fees include a one-year ISPE Membership, a $239 value.
Visit www.ISPE.org/Join for details on Member benefits and special rates for
Young Professionals, Students, Regulators, and persons from countries with
Emerging Economies.
www.ISPE.org/FacilitiesConference
EXTEND YOUR STAY TO ATTEND PROFESSIONAL DEVELOPMENT TRAINING
PROCESS VALIDATION
Understand how you can improve unit operation performance and contained processing, focusing on the
underlying science and engineering required to predict and maintain good performance.
•
•
•
•
•
Wednesday – Thursday | 29 February – 1 March
Managing the Risk of Cross Contamination: Applying the
Risk-MaPP Baseline® Guide
Are you ready for inspections? Would you like to run multiple products in a existing
facility but are worried about cleaning, cross contamination and GMP compliance? Want
to avoid 483 observations?
Attend Managing the Risk of Cross Contamination: Applying the Risk-MaPP Baseline®
Guide to take advantage of state of the art guidance and understand how to assess and manage
the risks of cross contamination, dramatically increase your manufacturing efficiency, maintain
product quality and improve GMP compliance and to:
• Determine when multi-product facilities can be used
• Use the logic diagram to guide a team through the process of determining how to manage the
risk of cross contamination
• Understand where to get health-based data for use in risk assessments
• Develop scientific risk-based cleaning validation limits
• Prepare a Quality Risk Management Plan for Cross Contamination
NOTE: This course will expand upon some basic concepts in the following areas so attendees
should be familiar with the basics prior to attending this session.
• Containment basics and the use of operator exposure limits.
• Setting cleaning limits (note this session will not discuss cleaning procedures, processes, etc).
Immediately apply the objectives using a complimentary copy of the
ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP).
Instructor: Stephanie Wilkins, PE, President, PharmaConsult US, Inc.
Course Level: Intermediate
CEUs: 1.3
* The training course registration is not included in the conference registration fee.
SCHEDULE AT A GLANCE
Registration will be open from 07.00 – 17.00 on Wednesday and Thursday.
Wednesday, 29 February
07.30 – 08.45
09.00 – 17.00
10.30 – 11.00
12.30 – 13.30
15.00 – 15.30
17.00 – 18.30
New Member/First Time Attendee Breakfast
Managing the Risk of Cross Contamination
Networking Break in Exhibit Hall
Lunch
Networking Break in Exhibit Hall
Evening Reception in Exhibit Hall
09.00 – 17.00
10.00 – 10.30
12.00 – 13.00
14.30 – 15.00
Managing the Risk of Cross Contamination
Networking Break in Exhibit Hall
Lunch
Networking Break in Exhibit Hall
Thursday, 1 March
How to Register
Online:
Visit www.ISPE.org/FacilitiesConference
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:
ISPE Headquarters, 600 N. Westshore Blvd., Suite 900,
Tampa, Florida 33609 USA
Questions?Call ISPE at tel: +1-813-960-2105, or email: ask@ispe.org
Written confirmation will be sent to you after your registration is processed
(time permitting). In order to be listed in the official delegate roster, you must be
registered and paid by 6 February.
Hotel Information
Hotel accommodations and hotel fees are separate from Conference registration fees. For room
reservations at the Conference venue, Grand Hyatt Tampa Bay, USA., call tel. +1-888-421-1442
or +1-402-592-6464. When making your reservation by phone, mention ISPE for a discounted
rate of $229 single/double. This rate is good until 6 February 2012, or until the room block is full,
whichever comes first. Please contact the hotel as early as possible to make your reservations to
ensure you are in the headquarters hotel.