Pharma IQ’s Cold Chain & Temperature Management Summit provides the largest and most comprehensive forum for Canadian pharmaceutical, biotech and medical device professionals involved in the temperature-controlled supply chain. Attendees are able to network with and learn from other organizations who face similar challenges in monitoring, controlling, and maintaining temperatures of products throughout the supply chain. All new discussions will include: review of Health Canada’s revised <0069>, Canadian importation strategies, specialty logistics, stability data and risk mitigation.
Getting Started with GFSI (For Manufacturers)TraceGains
If you have any questions or comments, please send them to connect@tracegains.com. We look forward to hearing from you.
Meeting Description:
Being compliant with a Global Food Safety Initiative (GFSI) recognized scheme can be a business accelerator, but is also often viewed as a daunting task. It doesn’t need to be.
Join our webinar to learn about the impetus for creating the GFSI, its benefits, and basic steps to get you going on the process to becoming compliant.
Karil Kochenderfer, GFSI’s North American representative, will start with an overview of the Global Food Safety Initiative and its benefits.
John Kukoly, Director of BRC in the Americas, will then give a general overview of what is required to begin the compliancy process with any GFSI-compliant scheme relevant to food manufacturers and ingredient processors.
Topics to be addressed:
-Why certification to a GFSI scheme matters to you
-Considerations in choosing a scheme
-The audit process explained
-Best practices for successful implementation
-Poor practices to avoid
-Key areas to focus on in planning and implementation
The webinar will conclude with both Karil and John taking questions from the audience.
About the Global Food Safety Initiative:
The Global Food Safety Initiative is a business-driven initiative for the continuous improvement of food safety management systems to ensure confidence in the delivery of safe food to consumers worldwide. GFSI provides a platform for collaboration between some of the world's leading food safety experts from retailer, manufacturer and food service companies, service providers associated with the food supply chain, international organizations, academia and government.
Paragon Scientific Limited specialise in the production of premium quality reference materials that include Density, Flash Point, Liquid Colour, Refractive Index, TAN/TBN and Viscosity standards.
Founded in 1994, Paragon have developed an international reputation synonymous with quality, prompt delivery, affordability, and first class customer service. A combination of advanced manufacturing techniques, the use of Primary laboratory test equipment and acute attention to detail enables Paragons to produce reference materials with some of the lowest levels of uncertainty of measurement available. Paragon's products are used in multiple industries throughout the world.
Food Safety: A Shared Responsibility – Key Highlights from the Global Food Sa...SGS
The GFSI Global Food Safety Conference is a unique annual event for bringing together over 800 leading food safety specialists from over 50 countries to advance Food Safety globally. The Conference provides the opportunity to meet and network with industry peers, share knowledge, benefit from though-provoking presentations from internationally reputed industry experts and hear innovative ideas to implement in your workplace.
In this presentation, we share highlights on key takeaways from the SGS Special Session and Breakout Sessions during the GFSC 2015 in Kuala Lumpur, Malaysia.
Barbados Agritourism Policy Setting Workshop 2019
Policy setting for improved linkages between agriculture, trade and tourism: Strengthening the local agrifood sector and promoting healthy food in agritourism.
Workshop organised by the Government of Barbados
In collaboration with CABA, CTA, IICA, CTO, CHTA, CDB
Courtyard by Marriott Hotel, Barbados, 27 & 28 March 2019
Introduction to GFSI Schemes - SAI GlobalRowenaCurtis1
Today’s food supply chain presents complex challenges, and many of the world’s largest food retailers are mandating supplier certification to Global Food Safety Initiative (GFSI) schemes.
This is the slide deck from SAI Global's Webinar with Senior Safety Consultant, Dr Bob Strong who gives an overview of the GFSI-recognised schemes - BRC, FSSC 22000, IFS Food, SQF Code, and Global G.A.P. The webinar provides you with an overview of GFSI schemes, their key differences, how to select the right standard for your organization, and tips on becoming certified.
________________________________________
Today’s food supply chain presents complex challenges, and many of the world’s largest food retailers are mandating supplier certification to Global Food Safety Initiative (GFSI) schemes.
In this webinar SAI Global's Food Safety Consultant Dr Bob Strong gives an overview The webinar will provide you with an overview of GFSI schemes, their key differences, how to select the right standard for your organization, and tips on becoming certified.
IQPC’s Cold Chain MENA summit will combine Supply Chain, Logistics and Quality leaders from Multi-national biopharma companies from the region and around the world as well as government and regulatory figures to discuss issues and proposed solutions that may occur across the supply chain.
For more information, visit www.coldchainmena.com
Getting Started with GFSI (For Manufacturers)TraceGains
If you have any questions or comments, please send them to connect@tracegains.com. We look forward to hearing from you.
Meeting Description:
Being compliant with a Global Food Safety Initiative (GFSI) recognized scheme can be a business accelerator, but is also often viewed as a daunting task. It doesn’t need to be.
Join our webinar to learn about the impetus for creating the GFSI, its benefits, and basic steps to get you going on the process to becoming compliant.
Karil Kochenderfer, GFSI’s North American representative, will start with an overview of the Global Food Safety Initiative and its benefits.
John Kukoly, Director of BRC in the Americas, will then give a general overview of what is required to begin the compliancy process with any GFSI-compliant scheme relevant to food manufacturers and ingredient processors.
Topics to be addressed:
-Why certification to a GFSI scheme matters to you
-Considerations in choosing a scheme
-The audit process explained
-Best practices for successful implementation
-Poor practices to avoid
-Key areas to focus on in planning and implementation
The webinar will conclude with both Karil and John taking questions from the audience.
About the Global Food Safety Initiative:
The Global Food Safety Initiative is a business-driven initiative for the continuous improvement of food safety management systems to ensure confidence in the delivery of safe food to consumers worldwide. GFSI provides a platform for collaboration between some of the world's leading food safety experts from retailer, manufacturer and food service companies, service providers associated with the food supply chain, international organizations, academia and government.
Paragon Scientific Limited specialise in the production of premium quality reference materials that include Density, Flash Point, Liquid Colour, Refractive Index, TAN/TBN and Viscosity standards.
Founded in 1994, Paragon have developed an international reputation synonymous with quality, prompt delivery, affordability, and first class customer service. A combination of advanced manufacturing techniques, the use of Primary laboratory test equipment and acute attention to detail enables Paragons to produce reference materials with some of the lowest levels of uncertainty of measurement available. Paragon's products are used in multiple industries throughout the world.
Food Safety: A Shared Responsibility – Key Highlights from the Global Food Sa...SGS
The GFSI Global Food Safety Conference is a unique annual event for bringing together over 800 leading food safety specialists from over 50 countries to advance Food Safety globally. The Conference provides the opportunity to meet and network with industry peers, share knowledge, benefit from though-provoking presentations from internationally reputed industry experts and hear innovative ideas to implement in your workplace.
In this presentation, we share highlights on key takeaways from the SGS Special Session and Breakout Sessions during the GFSC 2015 in Kuala Lumpur, Malaysia.
Barbados Agritourism Policy Setting Workshop 2019
Policy setting for improved linkages between agriculture, trade and tourism: Strengthening the local agrifood sector and promoting healthy food in agritourism.
Workshop organised by the Government of Barbados
In collaboration with CABA, CTA, IICA, CTO, CHTA, CDB
Courtyard by Marriott Hotel, Barbados, 27 & 28 March 2019
Introduction to GFSI Schemes - SAI GlobalRowenaCurtis1
Today’s food supply chain presents complex challenges, and many of the world’s largest food retailers are mandating supplier certification to Global Food Safety Initiative (GFSI) schemes.
This is the slide deck from SAI Global's Webinar with Senior Safety Consultant, Dr Bob Strong who gives an overview of the GFSI-recognised schemes - BRC, FSSC 22000, IFS Food, SQF Code, and Global G.A.P. The webinar provides you with an overview of GFSI schemes, their key differences, how to select the right standard for your organization, and tips on becoming certified.
________________________________________
Today’s food supply chain presents complex challenges, and many of the world’s largest food retailers are mandating supplier certification to Global Food Safety Initiative (GFSI) schemes.
In this webinar SAI Global's Food Safety Consultant Dr Bob Strong gives an overview The webinar will provide you with an overview of GFSI schemes, their key differences, how to select the right standard for your organization, and tips on becoming certified.
IQPC’s Cold Chain MENA summit will combine Supply Chain, Logistics and Quality leaders from Multi-national biopharma companies from the region and around the world as well as government and regulatory figures to discuss issues and proposed solutions that may occur across the supply chain.
For more information, visit www.coldchainmena.com
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S . FDA's current K-97-1 Memo / guidance document on "510(k) Device Modifications"
Supply Chain Prescriptions Improve Margins for Global Pharmaceutical CompanyAntuit
Antuit’s supply chain optimization models have helped the client achieve nearly US$2 million in cost savings, further enhancing the profitability of the company’s best selling product.
Fedegari Training & Education 2017 Calendar offers
programs that have been designed specifically to share experiences and allow our customers to develop a much deeper understanding of technologies and products in sterile processing and contamination control.
The purpose of Gap Analysis is to assist pharmaceutical manufacturers, distributors or 3 PLs (3rd Party Logistics Providers) to help them identify gaps in their cold chain supply chain network or systems.
What you will learn:
* The regulatory aspects related to the cold chain
* Responsibilities in the supply chain
* Requirements for the storage and handling of drug products
* Packaging, transportation and distribution of drug products
* Performing a gap analysis to know what needs to be done in order to fully comply with regulations and optimize your processes
* Ways and means to develop an executable action plan
How you will benefit:
* Understand how to execute a cold chain regulatory gap analysis
* Discover what should be covered when looking at cold chain compliance
* Gap analysis: The first step to develop a cold chain compliance program
* Uncover the requirements for the storage and distribution of drug products
* Sharing the responsibilities for a good cold chain compliance
Corporate Project: Wipro – Introductory Training Jessica Huynh
As a project for the course GENB 3302 at the University of Houston, our team created an introductory training presentation for the Downstream Division for Wipro.
The 8th Insurance Linked Securities Summit in Bermuda is a must attend meeting for the entire insurance-capital markets value chain including institutional investors, insurance and reinsurance companies, hedge funds, banks, law firms, underwriters and life settlement providers.
The structure of the conference – with dedicated tracks for the life and non-life sides of the market – ensures you walk away with two full days’ worth of strategies and solutions on the critical issues facing your market.
Attend Strategic Social Media for Healthcare to learn from industry visionaries on how to make the leap by taking your online presence to the next level, how to integrate new media efforts with traditional approaches and how to effectively engage with and attract current and future patient-consumers.
The 11th Annual Call Center Week is the fastest growing call center event in the world! This event designed to help companies create a customer-centric culture that inspires excellence and grows the top line. Attend Call Center Week and find out how to efficiently create a customer experience that produces engaged employees, drive performance improvement, leverage tools and social media for enhancing agent and customer satisfaction and prepare your organization for Voice of the Customer initiatives. Our practitioner speakers will share practical, measurable success stories needed to enhance business results.
IQPC’s 7th Timberland Investment Summit is the key meeting of the year for investment opportunities in the timberland asset class. Now in its 7th successful year, the conference brings together a comprehensive line-up of decision-makers from the entire timberland investments value chain including pension funds, hedge funds, endowments, family offices, TIMOs, REITs, forestry management companies, law firms, and banks.
Here’s a sneak peak at highlights of the 2010 program:
Highest ever participation from institutional investors, with speakers confirmed from Mass-PRIM, CPP Investment Board, TIAA CREF, APG, and Dallas Police & Fire Retirement System
Dedicated workshops on risk mitigation, carbon credits, and strategies for smaller investors
In-depth keynotes on the prospects for the US housing market, the macroeconomic outlook for timberland and the future of timberland values
Interactive roundtable discussions on the top 5 timberland investment opportunities
2010 promises to be an exciting year for the market. With an expanded program that includes 2 track dedicated to both insurance and longevity-linked investments, the 2nd ILS Summit Europe explores and debates the critical, providing investors with the information they need to invest effectively, profitably, and with confidence.
IQPC's 4th Annual Improving Solubility conference provides new solutions to measure, predict and improve solubility, ultimately maximizing time-to-market. Topics include applying lipid based formulations, overcoming physical instability, new drug delivery technologies, identifying in-vitro absorption and discovering formulations for toxicology studies.
3rd Life Settlements and Longevity SummitAbby Lombardi
IQPC’s 3rd Life Settlements & Longevity Summit has been specifically designed to help investors make sense of the opportunities and pitfalls of this investment class. Whether you’re an experienced investor or new to the market and still evaluating the suitability of the asset class, this conference delivers invaluable insights ensuring you make the best possible decisions for superior returns.
Topics will include: Federal Oversight New Investment Structures (Fusion and Sharia-Compliant products) Transitioning to the Tertiary market and many others!
8th Cold Chain Management & Temperature Control SummitAbby Lombardi
Pharma IQ’s 8th Cold Chain Management & Temperature Control Summit provides the largest and most comprehensive forum for Canadian pharmaceutical, biotech and medical device professionals involved in the temperature-controlled supply chain. Attendees are able to network with and learn from other organizations who face similar challenges in monitoring, controlling, and maintaining temperatures of products throughout the supply chain – from manufacturing, warehousing, wholesalers, pharmacies, hospitals, and ultimately to the end user.
Uncovering novel advances for increasing resistance in anti-infective drug development: The global anti-infective market is currently estimated at $66.5 billion, with anti-bacterial agents accounting for more than 50% of sales. Many biotechs and pharmaceutical companies are seeing developments in later stage clinical trials, specifically in anti-bacterial and anti-fungal, both of which are growing in demand. The threat of bacterial resistant strains of infectious diseases continually increases and creates a race to develop an effective resistant drug to combat these strains. The Anti-Infectives Summit will discuss effective lead generation approaches currently being used in anti-bacterial, anti-viral and anti-fungal drug discovery and address which biologics may play a role in anti-infective therapy.
Whether you have yet to invest in ILS, or are looking to diversify your portfolio and explore new products, the 7th Insurance Linked Securities Summit will ensure you make the right investment decisions by presenting a well-balanced perspective on the inherent risks and opportunities in the space, and the dynamic developments in technologies and tools so you can capitalize on this revolutionary asset class.
For more information, visit us at http://www.ilsnewyork.com
The Smart Metering Networking & Operations Summit provides the opportunity to exchange strategies and best practices for implementing a more stable grid – from required components to the recognition of realistic deadlines for deploying advanced technologies.
Engage with your peers to build a NEW BUSINESS MODEL for smart grid projects, ensure you are making the RIGHT INVESTMENT in technology and secure PUBLIC SUPPORT for your AMI pilots
In today’s drug development climate, clinical supply professionals face a unique set of challenges. These include adhering & complying with stringent regulations, using specialized temperature packaging and monitoring devices, evaluating cost-effective & validated distribution processes, shipping to and from research labs or hospitals and many more. The Clinical Logistics Supply conference will provide a unique opportunity to optimize logistics, overcome inefficiencies, develop safe vendor relationships and comply with US and international standards for your clinical supply chain.
IQPC’s 5th Forum on Laboratory Informatics will provide strategies for overcoming challenges, including:
- In-depth regulatory compliance guidance
- Extensive ELN deployment and roll out projects, focusing on ROI maximization and impact on business performance
- Informatics systems in the biobanking environment
- Proactive approaches to address challenges of integration and interfacing
- Integrating and embracing knowledge management and social media tools
IQPC’s 8th Polymorphism & Crystallization Scientific Forum is aimed at helping companies to lower costs, increase efficiency and cover a broad range of successful technical case studies on crystal nucleation and polymorphism – a major issue and area of drug development for the pharmaceutical and biotech industry.
7th Cold Chain Distribution for PharmaceuticalsAbby Lombardi
Only at the 7th Cold Chain Distribution for Pharmaceuticals, will you have the opportunity to network with the largest group of cold chain professionals, regulators and logistics providers. Key discussions include evaluating transportation strategy from top to bottom, developing KPIs & SOPs when qualifying 3PL providers, considering international shipment and import/export procedures and updates from regulatory agencies on new & proposed guidelines. Plus – don’t miss hearing from industry colleagues on Managing International Cold Clinical Supplies, during the NEW Post-Conference Focus Day.
2nd Life Settlements & Longevity SummitAbby Lombardi
IQPC’s 2nd Life Settlements & Longevity Summit has been specifically designed to help you – the investor – make sense of the opportunities and pitfalls of this exciting investment class. With more seniors turning to life settlement options and the need to diversify with an uncorrelated asset, 2009 has been a year of opportunity in these investments. However, following the life expectancy revision in 2008, many investors lost money on their portfolios and there remains widespread uncertainty regarding LEs currently in place. Whether you’re an experienced investor or new to the market and still evaluating the suitability of the asset class, this conference delivers invaluable insights from investors, fund managers, and industry experts, ensuring you make the best possible decisions for superior returns.
8th Lean Six Sigma for Pharmaceutical, Biotech & Medical Device ExcellenceAbby Lombardi
At the 8th Lean Six Sigma for Pharma, we will bring you real-world case studies that tackle the problems you are encountering, provide you with real-world solutions, and introduce you to industry peers who have been able to overcome many of the challenges Lean Six Sigma presents.
Walk away with tools for practical applications of Lean Six Sigma in R&D, transactional, business and training processes as well as along the supply chain.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
BÀI TẬP BỔ TRỢ TIẾNG ANH GLOBAL SUCCESS LỚP 3 - CẢ NĂM (CÓ FILE NGHE VÀ ĐÁP Á...
Cold Chain & Temperature Management
1. ✔ Sit down with Health Canada to discuss the updates to <0069> (due out by
early 2011) and understand what prompts inspections and what they look for during
audits
✔ Understand new PCCIG guidance around Risk Management, Stability Data during
'In transit' and Technical Report 46 on 'Last Miles'
✔ Improve quality throughout your supply chain organization by collaborating
with logistics teams and structuring your organization in a way that embeds QA into
everyday logistics
✔ Ensure compliance by understanding and comparing GDP updated regulations
around the globe and considerations for temperature control distribution
✔ Define a CRT or Ambient approach to temperature mapping study, route profiling
and risk assessment for specific channels
✔ Hear the wholesaler perspective on sharing stability data and collaborating with
the manufacturer to ensure supply chain and patient safety
Presents the
CC
February 22 - 24, 2011
Westin Prince Hotel, Toronto, Ontario, Canada
www.ColdChainPharm.com/Quality
Sponsored By:
Join 200+ of your industry colleagues at the only
Canadian event for cold chain and temperature
controlled pharmaceuticals. Attend to:
Hear from experts
in the industry:
Health Canada
Transport Canada
Canada Border Services
Agency
Eli Lilly, Canada
Canadian Association
for Pharmacy
Distribution
Management (CAPDM)
McKesson Canada
Medicines and
Healthcare Products
Regulatory Agency
(MHRA)
Pangaea Group
Johnson & Johnson
International Safe
Transit Association
(ISTA)
PCCIG USA Branch, PDA
Eli Lilly
Talecris Biotherapuetics
Johnson & Johnson
Medical Products
EMD Serono
2. What's New for CC
Updated International Regulations
** A unique opportunity! Don't miss the pre-conference interactive workshop with Health Canada
to discuss updates to <0069>, implementation in practice and work through case studies of recent,
real audits and how to avoid them
** Across the globe, regulatory focus is shifting from GMP to GDP. Join the Panel Discussion on what
these developing GDP guidelines look like and what temperature control elements are included
** Learn about new Generic pharmaceutical regulations and the impact of pricing pressures on today's
direct distribution channels and product movement in the supply chain
Temperature Mapping & Data Monitoring
** Learn how J&J has designed temperature mapping studies and used the results for sourcing
multiple solutions for CRT and ambient products
** CRT and Ambient: Discuss what exactly are the defined temperature ranges and how companies are
developing aligned approaches and finding cost-effective solutions
'Family Feud' Game Show: How Much Do You Know About Your
Supply Chain and Quality Teams?
Survey says...! The "Family Feud" Panel Session will have Supply Chain and Quality teams face off - asking
questions about who knows more about the other's role and responsibilities. The more serious discussion to
follow will focus on how quality can be integrated into an organization and everyday logistics operations
Driving Quality into the Complete Supply Chain and the "Last Miles"
** Get up to speed on new PCCIG Technical Report 46 "Last Mile" and what developing industry best
practice are for ensuring product integrity to the patient
** Hear the wholesaler perspective on sharing stability data and collaborating with the
manufacturer to ensure supply chain and patient safety
Canadian Importation and Distribution Strategy
** Transport Canada will speak about current screening cargo guidelines and the new developing screening
cargo guidelines - and they want your input too!
** Join Canada Border Services, Health Canada and pharma manufacturer stakeholders to discuss
practical, collaborative measures that can be taken to ensure efficient importation of temperature sensitive
pharmaceuticals for distribution into Canada
** Talecris Biotherapeutics will discuss how to gain greater visibility in a distribution process by aligning
processes between shipper, freight forwarder, airline and 3PL
** Eli Lilly will talk about quality aspects of outsourcing distribution - how new distribution models can
benefit all stakeholders
Packaging Innovations
** Learn about a new statistical methodology that analyzes and compares temperature testing
profiles and performance between shipping systems
** Following regulations, many companies are re-qualifying packaging. Hear a new case study on
re-design temperature control packaging to demonstrate a qualified system to regulators
2 Register by December 17th to Save up to $1,100!
15-25°
3. Pre-Conference Workshops Tuesday, February 22, 2011
Dear Colleague,
So much is happening in the pharmaceutical cold and supply chain right now...
• GDP guidelines around the globe are being revised
• Transport Canada has announced new cargo screening guidelines
• PCCIG has published Technical Report 46 on the "Last Miles"
• You are getting more pressure to find cost-effective temperature control logistics, comply with Canadian regulations, while at the same time being asked by
HQ in another country to follow their regulations, use their solutions and adhere to their processes.
It’s these reasons, plus many more, why people are already signing up for the 9th annual Cold Chain & Temperature Management Summit taking place
again in Toronto. The industry has come to recognize the annual event as a meeting of thought leaders and uses the networking event to get up to speed
with current regulations and industry best practices.
With thanks for the Advisory Board, we've put together a brand new program, covering today's most pressing challenges in temperature control distribution
in Canada and internationally.
Don't miss the industry favorite meeting place for best practice discussions on temperature controlled, quality distribution! We look forward to
meeting you this February in Toronto and welcoming you to the IQPC 9th annual Cold Chain & Temperature Management Summit.
Sincerely,
Courtney Becker-James
Conference Director
IQPC
A
OR
Evolution of the Cool Chain Processes
9:45 am – 12:30 pm Registration at 9:00.
At this xx hour workshop, get a close understanding of Air Canada Cargo's
cool chain process. Learn first hand, what role an airline plays in the cool
chain process in the handling of both active packaging shipments and passive
packaging shipments. Communication and partnerships play a critical role in
maintaing the intergrity of time and temperature pharmaceutical shipments.
Learn through case studies, the challenges faced by key stakeholders
(including freight forwarders, suppliers, front line employees, and others) to deliver on their
individual roles and responsibilies.
Workshop Leaders:
Ameet Sareen, Air Canada Cargo
Trevor Howard, Air Canada Cargo
Choose from Workshop B or C 10:30am - 1:30pm Registration at 10:00am (Lunch will be provided)
GDP Transport for Room Temperature Products
The group will discuss solution options and criteria for implementing best practice
transportation systems and procedures that appropriately blend the needs of your
product, your business, and available services. We will also explore the
effectiveness of various choices through interactive active discussion and case
studies.
• Procedural options to effectively protect room temperature products from
temperatures encountered during transport
• Applying the available options in the most cost-effective way for your individual
supply or distribution chain
Workshop Leader: Karl Kussow, Manager, Quality, FedEx Custom Critical
The geographic location and size of Canada represent potentially huge challenges to
pharmaceutical companies in protecting their temperature sensitive shipments in an
increasing regulated environment. This workshop is designed identify key issues
surrounding these challenges and methods available to address 1) Canadian weather
extremes 2) Available 3rd party profiles and how they apply to the Canadian market
3)Mapping projects done for Canadian shipments 4) Applications of Canadian based
profiles in new designs and design tradeoffs
Workshop Leaders: Jean Bédard, CEO, Alternatives Technologies Pharma (ATP)
Anthony Alleva, Technical Services Manager, Cryopak
B Identifying Temperature Profiles to Address the
Challenges of the Canadian Market Shipping LanesC
Choose from Workshop D or E 2:00pm - 5:00pm Registration at 1:30pm
Leasing Programs: Evaluating Options for
Temperature Sensitive Pharmaceuticals
Leasing containers and boxes for shipping temperature sensitive pharmaceuticals is
certainly trending up. This workshop will explore the opportunities of sustainability,
supply chain quality and cost-savings realized through setting up an effective
leasing program between the shipper and leasing program partners.
Key Perspectives:
Active: Stephen Maietta, Director of Sales, Americas, Envirotainer
Passive: John Howe, CEO, Active CC Boxes
Regulations drive company strategies and the solutions they implement. If your
products are being distributed in Canada, you must have a complete understanding
of what 0069 entails and expects. This workshop will give participants a great
opportunity to have open dialogue with HC regarding updates to Regulation 0069
and work in small groups to dissect real case studies of inspections, audits and
temperature control challenges.
Workshop Leader: Sarah Skuce, Compliance Specialist, Health Canada
D Understanding and Discussing Health Canada 0069
RegulationsE
3Register by December 17th to Save up to $1,100!
4. Conference Day One
Wednesday, February 23, 2011
7:45 Registration & Coffee
8:40 Pharma IQ Welcome
8:45 Chairperson’s Opening Remarks
Rafik H. Bishara, PhD, Technical Advisor and Chair PCCIG USA
Branch, PDA
8:50 Revisions to Health Canada's GUI-0069: End to
End Control of Temperature Sensitive Products
Sarah Skuce, Compliance Specialist, Health Canada
9:30 Improving Temperature Controlled
Distribution Practices: A UK MHRA Regulatory
Perspective Parameters of Increasing
Regulatory Concern
Ian Holloway, Manager, Defective Medicines Report Centre,
Medicines and Healthcare Products Regulatory Agency
(MHRA)
1:30 PDA Report on Stability Testing Data to
Support Distribution and ‘In Use’ Conditions
Rafik H. Bishara, PhD, Technical Advisor and Chair PCCIG USA
Branch, PDA
2:15 Enhance Quality within the Supply Chain using
Information from Traceability, Pallet Hygiene
and Security
Jack Sparn, Chief Information Officer, iGPS
2:55 Afternoon Networking Break in Exhibit Hall
Track A: Temperature Mapping & Data Monitoring
ISTA Standard 20 for the Design and Qualification of
Insulated Shipping Containers
Edward A. Church, President, International Safe Transit Association
(ISTA)
A Case Study of Rental and Leasing Programs for
Small Package Shipping
John Howe, CEO, Active CC Boxes
3:40 Conducting an Ambient/Controlled Room
Temperature (CRT) Profiling Study
Alan J. Davis, Supply Chain Temperature Control Leader,
Johnson & Johnson
4:25 Panel Discussion: Standardizing Room
Temperature and Ambient Approaches
Panelists:
John Collins, Director, QA, Novartis Pharmaceuticals
Canada Inc
Sarah Skuce, Compliance Specialist, Health Canada
Alan J. Davis, Supply Chain Temperature Control Leader,
Johnson & Johnson
5:05 Closing Remarks and End of Day One
5:15 Networking Cocktail Reception in Exhibition Hall
Re-Design and Re-Qualification of Temperature
Control Packaging: Case Study
Patricia Hanlon, Senior Director, Business Development, Marken Ltd.
Analyzing and Comparing Temperature Testing
Profiles and the Performance Between Shippers
Paul Harber, Associate Engineering Consultant, Eli Lilly
Track B: Packaging Innovations
10:10 Morning Networking Break in Exhibit Hall
10:55 Comparing GDP Regulations Around the Globe
and Considerations for Temperature Control
Distribution
Moderator:
Allan Reynolds, Vice President, Industry & Member Relations,
Canadian Association for Pharmacy Distribution
Management (CAPDM)
Panelists:
Ian Holloway, Manager, Defective Medicines Report Centre,
Medicines and Healthcare Products Regulatory Agency
(MHRA)
Rafik H. Bishara, PhD, Technical Advisor and Chair PCCIG USA
Branch, PDA
Representative, Health Canada
11:35 New Generic Pharmaceuticals Regulations:
Impact to Distribution Channels in Canada
Joe Knott, Founder and President, Pangaea Group
12:15 Networking Luncheon
INTERNATIONAL REGULATIONSINTERNATIONAL REGULATIONS
4 Register by December 17th to Save up to $1,100!
To view full session abstracts, please visit www.ColdChainPharm.com
Concurrent sessions begin: Choose Track A or B
“An eye opener on several topics. I enjoyed both days and would recommend such an event to other colleagues.
Also, networking was great” - PM of Quality Assurance Compliance, Abbott Laboratories
5. Conference Day Two
Thursday, February 24, 2011
5
To view full session abstracts, please visit www.ColdChainPharm.com
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“An outstanding compilation of speakers and topics, helping our industry to stay
on the cutting edge of technology and regulations” - Manager of Global Distribution, Biomereux
7:45 Registration & Coffee
8:15 Chairperson’s Opening Remarks
Jim Bacon, Senior Director, Global Demand Planning and
Customer Operations, Talecris Biotherapeutics
8:20 Opening Roundtable: Transport Canada’s New
Rules for Air Cargo
Jennifer Grandy, Chief, Program Design, Air Cargo Security,
Transport Canada
9:00 Importation of Temperature Sensitive
Pharmaceuticals into Canada
Mau'veen Dayrell-Johnson, Senior Officer, Trade Compliance,
Canada Border Services Agency
9:40 Panel Discussion A Collaborative Approach to
Efficient Importation and Distribution of
Temperature Controlled Pharmaceuticals into
Canada
Panelists:
Mau'veen Dayrell-Johnson, Senior Officer, Trade Compliance,
Canada Border Services
Sarah Skuce, Compliance Specialist, Health Canada
10:15 Morning Networking Break in Exhibit Hall
11:00 Gaining Visibility in the Cold Chain: Accessing
Data and Aligning Processes between Shipper,
Freight Forwarder, Airline, and 3PL
Jim Bacon, Senior Director, Global Demand Planning and
Customer Operations, Talecris Biotherapeutics
11:40 Distribution Model Case Study: Quality Issues
Surrounding Outsourcing Distribution
Sandra Usik, Associate Director, Regulatory Affairs & Quality,
Eli Lilly, Canada
12:20 Networking Luncheon
1:30 Considerations for Selecting 2-8°
Transportation Solutions for Distribution
within Canada
Silvia Castellarin, Manager, Transportation Canada, Johnson
& Johnson Medical Products
2:10 "Family Feud" - How Much Do You Know
About Your Supply Chain and Quality Teams?
During this session, Supply Chain and Quality will face off. Each
'family' or team will be surveyed questions about the other's
role, function and responsibilities. The purpose of the
questioning is to underline the knowledge gaps that exist
between the teams so organization can develop workable
solutions to bridge these gaps. The Panel Discussion to follow
will concentrate on how successfully integrate quality into
everyday logistics operations.
Quality Panelists:
Mandy Wagner, QA Project Manager, Merck Serono
Sandra Usik, Associate Director, Regulatory Affairs & Quality,
Eli Lilly, Canada
Dr. Mary Mazur-Melnyk, Chief Scientific Officer, Innovalinks
Quality Consultants
Supply Chain/Logistics Panelists:
Silvia Castellarin, Manager, Transportation Canada, Johnson
& Johnson Medical Products
Jas Kaloti, Logistics Supervisor, AstraZeneca
2:50 Networking Break In The Exhibit Hall
3:35 PCCIG Technical Report 46 "Last Mile": Best
Practices for Ensuring Product Integrity to the
Patient
Anthony (TJ) Rizzo, Strategic Account Engineer, Cold Chain
Technologies & Member, PCCIG TR 46 Task Team
4:15 Wholesaler Perspective: Communicating
Allowable Excursion and "Out of Storage'
Temperature Data
Claude Jolicoeur, Director, Regulatory Affairs, Corporate GMP
Officer, McKesson Canada
4:55 Closing Remarks and End of Conference
Who Will Attend the Cold Chain & Temperature Management Summit?
56% Pharmaceutical & Medicine Manufacturers
4% Bio-Technology
4% Medical Laboratories
4% Transportation
4% Logistics, Cargo and Storage
4% Government and Military
3% Health and Personal Care Stores
3% Public Health Program Administration
2% Medical Equipment and Supplies Manufacturing
16% Other
CANADIAN IMPORTATION
AND DISTRIBUTION STRATEGY
DRIVING QUALITY INTO THE COMPLETE
SUPPLY CHAIN AND THE "LAST MILES"
6. About Our Sponsors
Marken
Website: www.marken.com
Marken is one of the leading suppliers of cold-chain
logistics for clinical supplies worldwide. Temperature-control during the handling, storage
and distribution of cold-chain products is a critical element of the clinical trial process. Our
expertise is of critical importance to ensuring the safe arrival of high value shipments to
sites. We provide:
• Global distribution of temperature controlled trial medication, vaccines & CTM
• Temperature control monitoring for ambient, 2-8C and frozen products to maintain
integrity of supplies
• Advice on packaging materials and provision of containers for global transportation
• Refrigerated trucking services
• Customs brokerage accelerating clearance
Active CC Boxes
Website: www.activeccboxes.com
Active CC Boxes, LLC designs and manufactures high-tech
shipping containers for shipping temperature sensitive
pharmaceutical and biotech products. The Company rents
Kodiak™ containers by the trip or leases them on long term leases
and maintains a depot system in key locations to eliminate or reduce
return logistics costs for the containers.
Envirotainer
Website: www.envirotainer.com
Pioneer and market leader Envirotainer offers
flexible leasing (rental) of advanced transport solutions for worldwide air cargo shipments of
temperature-sensitive products. Customers within the healthcare, life sciences, food and
high-tech industries benefit from the combination of advanced container technology,
extensive cold chain management services and a global network of service partners, airlines
and forwarders - providing a unique one-way leasing service. Envirotainer secures the safety
and integrity of product cold chains by providing an active temperature-control system,
training all parties along the cold chain and supporting customers in transport validations
and risk management.
Kuehne + Nagel
Website: www.kn-portal.com
Kuehne + Nagel is a world leader in providing integrated logistics services for
manufacturers of pharmaceuticals, biotechnology, medical devices and other healthcare
products. Our services and solutions are designed to meet the exacting operational
requirements of this regulated environment (GxP). We do significant business with some of
the world’s leading pharmaceutical/healthcare companies, as well as other select customers
in the pharmaceutical, medical equipment, animal drugs, personal care and infant formula
categories. Kuehne + Nagel has developed a wide range of supply chain and information
management services to optimally manage healthcare firms' complex global procurement
and supply chain processes. We will assess current customer supply chain processes against
standard and industry benchmarks to identify areas for improvement. Using advanced
analysis and modeling tools, alternate models are evaluated against identified cost and
service objectives to arrive at the optimal solution.
Air Canada:
Website: http://www.aircanada.com/cargo/en/
solutions/ac_cool.html
Air Canada is Canada's largest full-service airline and the largest provider of scheduled
passenger services in the Canadian market, the Canada-U.S. transborder market and in the
international market to and from Canada. Together with our regional partner Jazz, Air
Canada serves over 32 million customers annually and provides direct passenger service to
over 170 destinations on five continents. Air Canada is a founding member of Star
Alliance™, the world's most comprehensive air transportation network.
Air Canada's cargo services division (doing business as "Air Canada Cargo") provides direct
cargo services to over 150 Canadian and international destinations and has sales
representation in over 50 countries. Air Canada Cargo is Canada's largest provider of air
cargo services, which are provided on domestic and U.S. transborder flights and on
international cargo services on routes between Canada and major markets in Europe, Asia,
South America and Australia.
FedEx Custom Critical
Website: customcritical.fedex.com/coldchain
FedEx Custom Critical offers a complete array of surface
and air solutions to safely and securely ship temperature-sensitive products. You can choose
from exclusive-use vehicles with temperature controlled cargo boxes to airfreight solutions
utilizing temperature-controlled air containers. With our Temp-Assure Validated services,
you also receive hard-copy documentation of the temperature inside the vehicle or
container throughout transport. This assists our pharmaceutical customers with their
compliance needs through a documented audit trail of their products’ temperature
throughout the shipping process. FedEx Custom Critical services are available 24/7/365 with
surface solutions throughout the U.S. and Canada and air solutions across the globe.
iGPS
Website: www.igps.net
iGPS operates the world’s first pallet rental service providing
all-plastic pallets with embedded RFID tags. Its highly
engineered all-plastic pallets are “lighter, stronger, safer and
greener” than platforms made of wood. iGPS recently introduced its iGPS Bios™ program,
specifically designed for the unique needs of the Pharmaceutical industry. iGPS bios pallets
are hand selected to ensure pristine quality, then washed and sanitized and, finally, enclosed
in protective wrapping to maintain their hygienic condition. Manufacturers that utilize the
iGPS bios program can be confident that the pallets they receive are free of paint,
pathogens and toxic pesticides and fungicides, like TBA.
Minnesota Thermal Science, LLC
Website: www.goldenhourtechnology.com
Minnesota Thermal Science, LLC develops unique storage
and shipping systems that address the challenges of maintaining
constant and predictable temperatures when transporting temperature sensitive medical
materials. Founded in 2004 following an industry wide search by the Walter Reed Army
Institute of Research for a more effective combat environment container, MTS has continued
to apply its technology to handle other important medical materials including all types of
biomaterials and pharmaceuticals that require controlled temperatures Its patent pending
Golden Hour® Technology, winner of a "U.S. Army Greatest Inventions" award, is credited
with saving soldier's lives on the battlefield and with revolutionizing the methods used for
distributing temperature sensitive medical supplies.
Cryopak
Website: www.cryopak.com
Cryopak (a TCP Reliable Company), specializes in the
field of temperature controlled packaging and services
including package design, qualification, testing
manufacturing insulated shippers, refrigerants, phase change materials and temperature
monitors. All services are provided in strict conformance with ISO 9001:2000, ISTA and ASTM
test methodology, and FDA good manufacturing practices. TCP maintains facilities in Quebec,
British Columbia, New Jersey and France.
World Courier of Canada Ltd.
Website: www.worldcourier.com
World Courier has set the benchmark for
worldwide time & temperature sensitive transportation. We remain the only specialist courier
company with its own global company network .Each office ISO 9001 certified with the same
operating standards dedicated to treating every shipment on an individual, priority basis.
World Courier is utilized in approximately 80% of the world’s clinical trials requiring the use of
a specialty courier. With experience in managing the logistics of over 7,500 clinical trials
worldwide, we are the acknowledged experts in handling temperature-sensitive specimen
and drug shipments.
Berlinger
Website: www.berlinger.com
Innovation has propelled the Berlinger Company
through the past 150 years. Our customer base
challenges us to build intelligent decision making tools for the entire cold chain process. Now
a temperature sensitive product can be monitored through the entire distribution cycle,
including the last mile. Berlinger products are approved by the WHO, UNICEF, and PATH.
They are used for monitoring product temperatures in storage and transportation. We
welcome your next temperature monitoring challenge.
Sensitech
Website: www.sensitech.com
Sensitech - The leading provider of cold chain visibility
solutions that enable our customers to track and monitor assets
across the supply chain, protecting the quality, efficacy, and
integrity of their temperature-sensitive products. Our product
portfolio includes comprehensive analytic services, enterprise software systems and validated
data acquisition devices. We address our customers’ most complex perishable cold chain
problems and deliver powerful insights that drive measurable process improvement. Sensitech
supports cold chain monitoring programs in 18 of the top 20 multi-national pharmaceutical
companies and 9 of the top 10 biopharmaceutical companies. Sensitech is a business unit of
Carrier Corp.
Skelton Truck Lines
Website: www.skeltontruck.com
Skelton has provided refrigerated services for 28 years to
Pharmaceutical/Biological companies. We partner with
customers to ensure we maintain product integrity through out the cold chain link. Our
Critical Care Division validated trailers are devoted for products that require 2°C to 8°C with
double reefers units to ensure the safety of the products. Our investment in assets, people
and training have provided our customers with a Tried, Tested and Proven solution that meets
and exceeds Health Canada 0069 regulations.
American Thermal Instruments, Inc.
Website: www.americanthermal.com
Founded in 1981, American Thermal Instruments,
Inc. has been exceeding customer expectations as an
international organization specializing in temperature
monitoring solutions. ATI temperature monitoring solutions include liquid crystal
thermometers, irreversible temperature indicators, color changing products, Log-ic® electronic
content monitoring, and microencapsulation services. Our facility is ISO 9001 certified, FDA
registered, and operates under cGMP. ATI manufactures non toxic, nonbreakable, reusable,
disposable and easy-to-read thermometers for diverse markets and applications. ATI acts as a
distribution arm for the Log-ic® Temperature Tracking System.
The Log-ic® system is revolutionizing the Cold Chain, giving customers the capability to track
and trace temperature history of shipments.
ATS Healthcare
Website: www.ats.ca
ATS Healthcare offers a broad range of transportation services
including temperature management offerings specifically designed
to meet the requirements of Health Canada guideline 0069. ATS is
focused on providing solutions within Canada for the healthcare
industry and as such operates a network of branches coast to coast and a fleet of
temperature controlled vehicles.
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❑ Workshop(s)
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CC
Presents the
CC
February 22 - 24, 2011
Westin Prince Hotel, Toronto, Ontario, Canada
Sponsored By: