Connecting a World of
Pharmaceutical Knowledge
rorlntern,IICuculatJOilOnly
News For ISPE India Members
Contents at a Glance
Editorial. ...................................................................... I
ISPE's new President and CE0 ..................................... 2
Much More than a Volunteer........................................... 2
Conference Reports ...................................................... ..... 3
ISPE Facility of the Year Award .......................................... 5
Save Your Date
For
ISPE Annual Conference
On
Jubilant- FICCI Quality Systems Excellence Award 2011 .... 6
63rd IPC Scientific Programme, A Brief Report ..................... 6
12th & 13th October, 2012
New Releases ............................................... ............................. ?
ISPE Publications........................................................................ 8
ISPE Membership .......................................................................... 9
At
Hyatt Regency, Mumbai
Event Calender............................................. ............ ...................... .. 10
Editorial
ISPE India has grown from strength to strength in the current financial year. Our Hyderabad Chapter
has been very active and had organized conferences locally on Current Trends in "Design, Validation of
Biopharma I Sterile Facilities" and " Aseptic Process & Compliance," at Novotel & HICC Complex
near Hitec city, Hyderabad. The Affiliate had organized the now popular YPEP conferences,
in 2 1st January, 2012 on "Getting Ready for New Changes in Pharma Operations," at WelcomHotel
Vadodara, Gujarat.
We were sad to see our friend & mentor Bob Best leave ISPE. As Tennyson said: the old order changeth
yielding place to new. We now have a new President & CEO Ms. Nancy Berg. Read all about her in our News letter and about her 100
days in office. Similarly another old order has changed: Kapil Bhargava has taken over from Raghu as the COP head in India.
ISPE continues to be the Association of choice for Regulators around the world. Dr. Salim Veljee has joined our Association and is a
very active volunteer for education & training. ISPE conducts all its programs in China with the SFDA the China Regulatory Agency.
By the time you read this the ISPE India Affiliate would be in the process of electing new members to the Board. In our next issue we
shall give you details of the newly elected Board Members. We then shall embark on a business plan to strengthen ISPE India further by
starting more Chapters and by bringing more local programs . We have also been getting offers ofhelp by volunteers from amongst our
members. We welcome them but also encourage members from outside Mumbai to volunteer for local Chapters. We also request each
one ofyou to please recommend a colleague or a friend to us, who may like to become a member. We shall contact the person with forms
for membership with details ofbenefits of membership. Help us grow so that we can help your growth in the life sciences.
GopalNair
Vice Chairman,
ISPE India Affiliate
ISPE 's new President and CEO
On behalf of the Board of Directors, please welcome Nancy S. Berg as ISPE's new President and CEO. Nancy
comes to ISPE with an extensive background ofleadership, strategic growth and relationship-building. Berg spent
much of her career with the Society of Manufacturing Engineers (SME), serving as its Executive Director/CEO
from 2000-2006 when she left to start her own businesses. She led the development of SME's strategic plan and the
expansion of its technical networks. She also drove the launch of a vital transformation process that prepared the
organization for anticipated changes in manufacturing industry business models, emerging competitive forces and
the impact of globalization and expanded supply chains.
Berg worked in other strategic roles at SME, both domestic and international, where she led exponential revenue and membership
Growth and Program/product development. In addition, she brings experiences as an entrepreneur and a strategic consultant to both
commercial and nonprofit organizations.
Nancy Berg has a passion for working with technical and manufacturing organizations. At SME, she was responsible for a $30 million
budget, 25,000 members, 150 staff and a global network of more than 300 chapters and 100 partnerships in 30 countries. In her
successful initiative to expand SME's technical meetings and events operations, she facilitated dialogue, joint ventures and coalitions
involving trade groups, associations, companies, governments and agencies in multiple industries. She brings links to other
manufacturing industries and associations, along with knowledge and experience in association best practices.
Once you meet Nancy Berg, you will appreciate the energy and vision she will bring to our association and staff. She has many ideas for
involving members, their companies and other stakeholders in building on the successes of ISPE. Her vision to motivate the
pharmaceutical engineering and manufacturing communities to build solutions to industry-wide issues and barriers to competitiveness
comes at a time when companies are experiencing significant pressures to control costs and improve productivity. She looks forward to
hearing from members, customers, partners and the media as she develops the Forward Agenda for ISPE.
Much More than a Volunteer
If you've been a long-time member ofiSPE, then you probably know how important volunteers are to the success ofiSPE initiatives.
Volunteers create our content, present our education sessions, run our Communities ofPractice and manage our Affiliates and Chapters.
The International Board of Directors, who set the direction for the entire Society, is made up entirely ofVolunteers. So, it's easy to see
why ISPE needs our Volunteers. But have you ever wondered why so many busy professionals are willing to donate their time and talent
to do all this?
It' s because they want to change the world, that's why. And it's because they know they are so much more than "Volunteers" - they
understand that their work for ISPE makes them Industry Influencers.
People join ISPE for a lot of different reasons - because they want to enhance their resumes, because they have professional mentors
who recommended they do so, or because they want to gain access to other industry professionals for networking. But most people join
because they actively want to make a difference. Our Volunteers understand that the only way to do that is by getting involved in ISPE
activities.
ISPE Volunteers are the driving force behind industry change. They influence global regulations, international best practices and
industry mindsets. They work with colleagues from across the entire supply chain to find better, safer and more cost-efficient ways to
ensure that patients have reliable access to life-saving medication. They change the world.
Aside from these benefits, volunteering also leads to increased career success. ISPE Volunteers have more access to and greater
credibility with global regulators. They get to meet, learn from and work alongside some of the top minds in the pharmaceutical
industry. They gain respect at work for bringing prestige and good ideas to their companies. In some cases, they become globally
recognized industry voices in their own right.
The professionals who work through ISPE to share their knowledge with the world really are much more than "Volunteers." These
experts aren' t simply giving their time, they are shaping their industry and their careers through their participation in ISPE initiatives.
They are truly Industry Influencers.
BLOCK YOUR DATES
ISPE INDIA ANNUAL CONFERENCE ON
FRIDAY, 12 & SATURDAY, 13 OCTOBER 2012
2
Conference Report
ISPE Annual Conference 2011 Report
The ISPE India Affiliate organised a two-day conference, themed "From Basic GMP to a Q 10
Pharmaceutical Quality System", on 21-22 October 2011 at the Hotel Intercontinental The Lalit,
Mumbai. It was attended by over 100 participants from the Biopharmaceutical, Life Sciences,
Pharmaceutical Manufacturing, Pharmaceutical Engineering and Design, Consultants,
Regulatory, Computer System Validation, Food industry, API Manufacturing, Pharmaceutical
Formulations industry.
Conference Day ! - Friday, 21 October 20 II
Mr. Ajit Singh, Chairman ofiSPE India Affiliate delivered the welcome address and Mr. Gopal
Nair, Vice Chairman of ISPE India Affiliate provided an update on ISPE Worldwide and its
Affiliates and Chapters. ISPE President, Mr. Bob Best, in one of his last appearances as active
President, spoke about ISPE membership and its benefits. He was awarded the ' Life Time
AchievementAward' by the Board and Executive Committee Members ofiSPE India Affiliate.
The session was followed by Mr. Bruce Ross, US FDA India Director, who shared the
importance of compliance with basic GMPs and illustrated the serious impact of noncompliance due to compliance failures. Mr. Gerald W. Heddell, Director of Inspection,
Enforcement and Standards Division- Medicines and Healthcare products Regulatory Agency
(MHRA), shed light on why regulators look for effective Quality Systems during their
interactions with companies. He also touched on how inspectors perceive management
responsibility in the context of the establishment and maintenance of a robust system. Heddell
then spoke on the Application of Quality Risk Management to an inspection program and RiskBased Inspections approaches.
The following session was led by Dr. Alok Ghosh, President of Technical Operations - Lupin
Limited. He talked about the Importance of Quality Management, the important roles of senior
management and the cost of poor quality and failure to comply with basic GMPs. Mr. Bryan J.
Wright, who is the ISPE European Regulatory Affairs Advisor, provided the overview and
details on ICH Q l 0 and Pharmaceutical Quality Systems.
Mr. Rob Hughes, Director of Programming CI in R&D, Astra Zeneca, spoke about Process
Performance and Product Quality Monitoring (PPPQM). He provided the delegates with a
better understanding on the Product Lifecycle approach and the important tools to implement
PPPQM. This was followed by Dr. Thirunellai G. Venkateshwaran, Associate Director, Global
Regulatory Affairs- Wyeth Research Division, USA, who shared insights on Corrective Action
Preventative Action (CAPA) implementation. Dr. Chris Watt, (Ex US FDA), Senior technology
Partner - NNE Pharmaplan, spoke on Continued Process Verification and provided useful
examples of process monitoring including the use of statistical techniques applied to different
types of drug products and drug substance.
The first day ofthe conference ended with an interactive session whereby all participants had the
opportunity to exchange ideas and thoughts with the panel of regulators and industry speakers.
Conference Day 2 - Saturday, 22 October 20 II
Day 2 began with Mr. Bryan J. Wright providing a brief overview and recap of the topics
discussed on Day l of the conference. As a continuing theme, Dr. Chris Watts spoke on the
necessity for management review within a PQS. The session continued with Mr. Rob Hughes
sharing insights on Section 2.7 of ICH QlO i.e. Management of Outsourced Activities and
Purchased Materials. Mr. Wright also provided an overview on Q9, Quality Risk Management,
and how it applies to compliance issues.
Pa rtic ipants s tay ing e ng a ged a t the India Affi lia te Confe re nce
3
Conference Report
Mr. Gerald W. Heddell, as a regulator, discussed how Quality Risk Management can be applied to establish a compliance inspection
programme. He also touched on Risk-Based Inspection objectives and process.
Mr. Bruce Ross, M.A. M.P.H. Country Director, India Office, spoke about FDA's International Enforcement/Inspection Priorities and
Process. He shed light on Major Inspection Types, FDA inspection processes, Systems-Based Approach and the top 10 cGMP
deficiencies cited in 2010 for International inspections, including India.
The conference participants were divided into three breakout groups, each lead by a speaker and regulators to discuss the following
topics:
• Obstacles and positives in applying Q 10
• Senior management responsibilities in applying Q 10
• Best approach to outsourcing
Dr. Albinus D'Sa, US FDA, Deputy Director, India, provided a regulatory perspective on the Application of ICH Q8, Pharmaceutical
Development under a Pharmaceutical Quality System.
The conference ended with an interactive session wherein the participants had the opportunity to raise questions and clarify any doubts
they had with the panel of regulators and industry speakers.
ISPE YPEP One Day Workshop, Vadodara, Gujarat, India
"Gettin:: Ready For New Chan::es In Pharma Operations"
ISPE India Affiliate under the leadership of the Steering Committee for GCLP COP, organized a one-day workshop on 21st January
2012 at Hotel WelcomVadodara, Vadodara (Baroda), a city in Gujarat, India where there is a good conglomeration of big and medium
scale pharmaceutical companies. The Chief Guest for the one day event was Dr Hemant Koshia, Commissioner, Food and Drugs
Control Administration, Gujarat State, who complimented ISPE for organizing such a very useful event in Vadodara for the first time.
Dr Koshia, an all time supporter of such educational events, requested ISPE to conduct many more such events in other parts of the
country including the State of Gujarat. The programme was also attended by Dr A Ramkishan, Asst Drugs Controller, Central Drugs
Standards and Control Organization, Ahmedabad and Dr Bharat Patel, Joint Commissioner, FDA Testing Lab, Vadodara.
The programme included an opening session by Mr. Gopal Nair, Vice Chairman, ISPE India Affiliate who briefed the participants on
the benefits oflSPE membership. The different topics for the event included:
• Mr. S G Belapure, President, Zydus Cadi Ia presented on ' Quality by Design [ ICH Q8]'
• Mr. R R Tuljapurkar, President- Manufacturing Formulations, Z ydus Cadi Ia briefly touched on ' CAPA and Root Cause Analysis'
• Mr. Kapil Bhargava, Former Dy. Drugs Controller (1), CDS CO spoke about 'Quality Systems Approach [ ICH Q 10] '
• Dr. Dushyant Patel, President & CEO, Astral Pharmaceutical Industries discussed' Management Reviews'
• Mr. R Raghunandanan, Former Vice President- Quality (South Asia), GSK talked upon 'Quality Risk Management [ ICH Q9]'
• Mr. Vijay Kshirsagar, Executive Vice President, Unichem Laboratories Ltd. Presented on 'Validation- New US FDA guidelines'
All the speakers were experienced industry leaders and they shared their experiences to make the sessions very illustrative. The
workshop was concluded with an hour long question and answer session.
The participants about 110 in number were a mix of junior and middle level managers from APis and Drug Products manufacturing
units as well as from support industries. They interacted well during the sessions and were appreciative ofiSPE's efforts in conducting
such useful events. Many participants expressed their desire to become members oflSPE.
The need for conducting many more such events was evident at the end of the day and the leadership ofiSPE India Affiliate will take
necessary actions to make this happen for the benefits ofPharma professionals.
ISPE Facility of the Year Award
EISAI Knowledge Centre, Vizag
The Eisai Knowledge Centre, winner of the 2012 Facility of the Year Award for 'Project Execution", is hailed as the first large
production facility in India by a major Japanese pharmaceutical company.
Located on a Greenfield site in Visakhapatnam, Andhra Pradesh, India, this contemporary Active Pharmaceutical In-gradients (API)
Research and Production and Oral Solid Dosage (OSD) Manufacturing complex spans 50 acres and comprises 14 independent
buildings.
The drug product facility has an annual capacity to produce approximately two billion tablets. The drug substance facility has an annual
capacity of 30 tons. R&D and manufacturing are supported by 12 other facilities located within the complex, including warehousing
(raw materials, packaging materials, and finished goods), engineering services, quality assurance (validation, stability, etc.), quality
control, information technology, process development, regulatory and administration.
The site integrates API research, support, and manufacturing facilities into one flexible, state-of-the-art complex, increasing Eisai's
capacity and capability to research, scale-up and manufacture multiple API products simultaneously.
The entire facility was built in just 17 months for an investment of under $50 million. Also remarkable was the project team's ability to
overcome the challenges of delivering a project of this size, given the complexities of doing so in India.
To achieve such an aggressive deadline, construction activities for all 14 facilities began simultaneously and in parallel. The center's
innovative design and project size demanded a well-organized and coordinated effort to deliver a successful project, which was
achieved by robust project management practices, including upfront planning, continuous monitoring and communication, and
resource management.
The entire project was handled by one project team and at its peak 2,000 personnel were working at the site. Remarkably, despite five
million man-hours worked, there were no reportable safety incidents.
The Eisai Knowledge Centre is a unique, completely integrated complex that offers state-of-the-art flexibility, capability, and capacity,
mitigating risk of global supply chain interruption and meeting current and future strategic drug development/manufacturing needs.
Jubilant- FICCI Quality Systems Excellence Award 2011~-------
With awards galore, Jubilant Life Sciences Ltd (JUBL ), Mysore is one of the most
recognized organizations in the Pharma space. Their longstanding reputation is
braced to continue with strong growth in the future. They have received innumerable
corporate awards that speak for the innovations introduced by them and the various
milestones achieved. Under the leadership of its Senior Vice President (Operations)
and ISPE Board Member, Mr. Biswajit Mitra, JUBL has reached greater heights in
terms ofManufacturing excellence and Quality Systems.
They are proud to be recognized by important organizations and publications for the
many ways they have embraced Quality Systems in Pharma Manufacturing. They
have three awards to their credit in the last few months. They were awarded the FICCI
Quality Systems Excellence Award 2011 for Good Practices in Quality Systems, thus
being the only organization along with GlaxoSmithkline Consumer Healthcare Ltd,
Rajahmundry to receive the coveted Gold Prize in Medium Size Category. In addition,
the organization has secured First Place at en Southern Region QC Circle
Convention held at Chennai in September 20 11 , for best-in-class Quality Circle
activities in the industry. They have also bagged the award under 'Tools &
Visualization' category at Cn Quality Circle competition held at Bangalore in the
month ofN ovember 2011.
JUBL, Mysore have been consistently recognised for their commitment to best
practises in the area of Environmental Health and Safety. In November 201 1, they
have been conferred the e n National Water Management Award 2011 under the
category 'Excellent Water Efficient Unit (Within Fence Category)'.This has been
awarded recognizing the Water Management Initiatives at JUBL, Mysore. During the
month of March 2012, they received the 'Best Safe Industrial Boiler Award 20 11' and
also secured First place in Medium Scale Category in Cn Southern Region Excellence
Award in Environment, Health & Safety for the year 20 11 . The awards were instituted
by Department ofF actories, Boilers, Industrial Safety & Health and Confederation of
Indian Industry (CII) Corporate Sustainability Initiative Forum respectively. These
awards recognise JUBL's outstanding commitment to responsible Safety &
Environment management at all levels within its operations.
63rd Indian Pharmaceutical Congress Scientific Programme- December, 2011
The 63rd Indian Phannaceutical Congress was held in Ban galore from Friday, 16th to Sunday, 18th December 201 1successfully.
The main highlight of the congress was the power-packed scientific programme, exhibition of equipment and machinery, international
buyer- to-buyer meet etc. The scientific sessions of the 63rd IPC were current and contemporary and were in line with the conference
theme "Vision 2020, India The Pharma Powerhouse". The programme included 14 symposia and 73 topics.
For the first time in the history of the congress, a special full day, ISPE sponsored track was included in the scientifc programme. The
ISPE track was designed to support the theme of the event and covered some of the latest topics such as Product Quality Lifecycle
Implementation, Quality by Design, Quality Risk Management, Change Control Management, Lean Manufacturing, New USFDA
Guidance on Process Validation and Technology Transfer.
Ajit Singh, Chairman, ACG Worldwide, Mumbai and Chairman, ISPE India Affiliate, was Chairman of the Symposium on ' Product
Quality Life Cycle Implementation' . Mr. S M Mudda, Executive Director-Technical & Operations, Micro Labs Ltd, Bangalore and
Board Member, ISPE India Affiliate, was Chairman of Scientific Services Local Organizing Committee and under his guidance the
63rd IPC experienced stupendous success.
New Guide Release:
-~
Guido
Comparator
Management
Packaging, Labeling,
and warehousing
Facllnles
Comparator Management
INR 3,250/INR 3,250/-
Applied Risk
Management tor
Commissioning and
Qualification
ProJect Management
tor the
Pharmaceutical
lndustrv
Water and
Steam
svstems
Applied Risk Management
for Commissioning and
Qualification
Stertle Product
Manutacturlng
Facilities
Project Management
for the Phamaceutical
Industry
Water and Steam Systems
(Second Edition)
Sterile Product
Manufacturing Facilities
(Second Edition)
· =lice
Guido
Interactive Response
Technology
Assessing the
Particulate Containment
Performance ot
Pharmaceutical Equipment
Electronic Format Only
~ PQU
IIMI......
~ PQLL
.......... -=-=-=--=
-=-=-=-.....=
Pll'lt -Product Realzatlan uU1g
Quality by tiOIItln (QbO): c ........ and
Pl'inciples
....... -...~ ........... c.ww .......
Assessing the Particulate
Containment Performance
of Pharmaceutical Equipment
(Second Edition)
Port 2 - ProdUCt Rellllltlan uU1g
Quality by Design (Qtlll): lluatratfvo
Ex. .
Part 1: Product Realization
using QbD, Concepts and
Principles
7
Part 2 : Product Realization
using QbD, Illustrative
Example
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Baseli ne Pharmaceutical E ng ineering G uides
API 0607
OSDI I09
STER09 11
WAT1211
CQO IO I
RISK0910
BI00604
1-93 1879-00- 1
1-93 1879-06-0
1-93 1879-06-0
1-931879-09-5
4,500.00
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Active Pharmaceutical Ing redients Baseline Guide
Oral Solid Dosage Fonns Baseline Guide (Second Edition)
Sterile Manufacturing Facilities Baseline Guide (Second Edition)
Water and Steam Systems Baseline Guide (Second Edition)
Comm issioning and Qualification Baseline Guide
Ri sk Based Manufactu re Of Pharmaceutica l Products (Risk MaPP )
Biophannaceutica l Manufacturing Facilities Baseline Guide
GAM P GOOD PRACTICE GUIDES
5 BOUND
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4VLCS
4fT
4G IS
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GG PGOGCS
GGI'GMES
GGPGPC
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IG PG MA INT
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TT0303
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CMGUIDE
C MHB 2006
C MRETGD
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PQLI2
IG f>GARMCQ
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IGPGCMG MT
G MP035
GMP036
GM J>037
GMP038
GMP039
GMP044
GM f>045
GMP048
GMP046
GMP049
GMP046
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1-931879-43-5
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A Risk Based Approach to GxP Complaint Computerized Systems-GAMP5
A Risk Based Approach to Compliant Electronic Records and Signature
Validation Of Laboratory Computerized Syste ms
IT lnfrastnocturc Control and Compliance
Global Information Systems Control and Compliance
Electronic Data Archiving
A Risk Based Approach to Operation Of GxP Computerized Systems
Manufacturing Execution Systems- A Strategic and f>rogram Management Approach
A Risk Based Approach to GxP Process Control Systems
A Ri sk Based Approach to Calibration Management (Second Edition )
ISPE GOOD PRACTICE GU I DE AND OTHER
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Good Practice G uide: Maintenance
Good Engineering Practice
Good Practice G uide: Heating, Ventilati on. and Air Conditi oning (IIVAC)
Technology Transfer
Assessing the Paniculate Comainmentf>erformancc Of Pharmaceutical Equipment
Introduction Guide to C linical Materials
Comprehensive Guide to C linical Materials
Investi gational Materials Sample Retention Guide
Commission in g & Qualification of Pharmaceutical Water & Steam Systems
1SPE Good Practice guide: Process Gases
Science and Ris k Based Approach for The Delivery of Facilities, Systems and Equi pment
ISI'E Good Practice guide : Cold Chain Management
Development of Investigational Therapeutic Biological Products
Good Pmctice Guide: Project Management for the Pharmaceutical Industry
Pan 1- PQLI- Product Realization using QbD, Concepts and Principles
Pan 2- PQLI- Product Realization using QbD, Illustrative Example
Applied Risk Manageme nt for Commissioning and Qualification
ISPE Good Practice Guide: Interactive Response Technology
ISPE Good Practice Guide: Packaging, Label ing_ and Warehous ing Facilities
Assessing the Paniculate Containment Performance of Phannaceutical Equipment
(Second Edition)
Comparator Ma nagement
REGULAT ION AND GUIDANCE M IN I- II AND BOOKS
Phannaccutical (2 1 CFR Pans 210. 2 1 I)
Medical Device (21 C FR Pans 820)
Blood (2 1 C FR Pans 606)
Food (2 1 C FR Pans I 10)
Medical Devi ce Qua lity Syste ms Manual
Electronic Records: Electronic Si gnatures (21 CFR Pan I I)
Q7A ICII Guidance for A Pis
IC I-I Q8
IC I-I Q IO
Dietary Supplements (2 1 CFR Part I I I)
IC H Q9 - Quality Risk Ma nagement
I
5,650.00
3,250.00
3,250.00
3.250.00
3,250.00
3,250.00
3.250.00
3,250.00
3,250.00
3.250.00
3,250.00
3,250.00
3,250.00
3,250.00
3,250.00
325.00
3,250.00
150.00
3,250.00
3,250.00
4,500.00
3.250.00
3,250.00
3,250.00
3,250.00
3,250.00
3.250.00
3,250.00
3,250.00
3,250.00
3,250.00
115.00
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115.00
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ISPE Membership
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Here's how it works:
For eve y end you refer who joins ISPE, you'll earn one free month of
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Gwd I
ble r
Co nnect ing a Wo rld of
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• "Acmb rs r em nvc e
as are u/1 of yw efforts
9
II
Event Calender
July3-4
ISPE United Kingdom Affiliate HVAC
two day tra ining course
http://www. ispe.org/ uk/event-3-4-ma rc h-20 12
July 10- 11
ISPE Spain Affiliate Event- Calidad I Quality
http://www.ispe.org/ spainlevent-1 0 / 1 1-july-20 12
July 19
San Francisco/B ay Are.a Fun D ay
Golf Tournament & Wme ry Tour
.
http://www. ispe.org / san-francisco/ 19-July-Fun-Day
July 24
ISPE New Jer sey Chapter Event
http://www.ispe.org/new-jersey/ Coming-Soon-Event
October 2
ISPE UK Affiliate - Gamp Event
http://www.ispe.org/uklevent-02-oct-20 12
October 12 - 13
ISPE India Annual Conference
ISPE India Affiliate
October 17 - 18
November 11 - 14
Brooks Merrion Hotel,
Leeds
Barcelona/ Madrid
Spain
Poppy Ridge Golf Course
C 1c
·
a ILOffila
Alderley Park
Cheshire
Hyatt Regency, Mumbai
India
ISPE Spain Affiliate Event- Biotechnology
http://www. ispe.org/spain/event-17I 18-october-20 12
Annual Meeting- Global GMP Solutions through
Innovation and Transformation
http://www.ispe.org/20 12annualmeeting
Barcelona
Madrid
San Francisco
California USA
November 22
ISPE Nordic Affiliate - Next Generation Manufactureing
http://www.ispe.org/nordic/event-2 1-november-20 12
November 23
ISPE Spain Affiliate Event
http://www.ispe.org/spain/event-23-november-2012
December 3 - 6
ISPE 2012 Training Series - Classroom Training
http://www. ispe.org/20 12decembertraining
10
Malmo/Sweden
Madrid
InterContinental Hotel
Tampa, Florida USA