Leadership

Leadership is not about being charismatic or having a large fan base, it’s about upholding personal humility and professional will. At LifeConEx, we will continue to produce leaders and set an example for the industry.

Management Team

David Y. BanG CEO

david bang

David's Blog

David Bang is passionate about his job at LifeConEx; he is surrounded and supported by diversified and highly competent LifeConEx employees who are dedicated to connecting people with life in day-to-day tasks and to every single shipment at a time. Prior to his appointment, Bang served as a founding member and senior vice president of business development & implementation of this supplier-neutral startup that was founded in 2005.

Bang has worked within the industry for over 13 years, holding multiple positions in global contract acquisition, implementation, sales, finances, IT and strategy. He is an author of many articles published in relevant trade and technical magazines and a frequent speaker at various logistics and life sciences conferences worldwide, advocating for the reduction of risk, elevated ROI and, ultimately, patient safety.

John Liebe Head of Sales North America

John Liebe joined the North American sales team at LifeConEx in 2006, bringing with him over 15 years of operational and sales leadership experience in all modes of transportation. In January of 2007, he became Head of North American Sales, leading the team responsible for developing LifeConEx’ customer relationships and increasing market presence in the US, Puerto Rico and Canada.

Prior to joining LifeConEx, Liebe was a global account manager with BAX Global where he was responsible for helping industry-leading pharmaceutical, medical device and technology companies address their logistics challenges and improve supply chain visibility and efficiency. He began his logistics career with Nippon Express where he held air export and sales positions and managed a satellite office that focused on the technology and pharmaceutical markets being developed in the Research Triangle Park.

Liebe participates regularly in pharmaceutical and cold chain industry conferences, sharing his expertise in workshops and panel discussions.

Federico Lupp Head of Sales Europe & Latin America

Federico Lupp has held the position of Head of Sales Europe and Latin America at LifeConEx since September 2007. Between 2005 and 2007, Federico was a Sales Manager at LifeConEx for the US and Canada. Before joining LifeConEx, he was a global industry manager for the Americas at Lufthansa Cargo. Prior to Lupp’s transfer to the US in 2002, he was based in Buenos Aires, Argentina, where he served as a regional business development manager for Lufthansa Cargo within the pharmaceutical, automotive and telecom industry for South American operations.

Lupp attended Veterinary Medicine School at the Universidad de Buenos Aires, and earned a master’s degree. He is of German descendent, born in Argentina, and currently resides in Frankfurt, Germany.

Gordon Johnson Head of Strategic Innovation

Recently, Gordon Johnson was challenged to spearhead the creation of the Strategic Innovation Unit within LifeConEx to further develop the company in areas of strategy, innovation, business intelligence, marketing, product development and project management.

Beginning his career in the logistics industry in 2004, Johnson developed an interest in the biopharmaceutical industry. He was selected by DHL Danzas Air & Ocean (now DHL Global Forwarding) to join a small group of individuals to drive the formation of a joint venture with Lufthansa Cargo specializing in the logistics process management of biopharmaceutical products. As the Director of Business Development & Implementation at LifeConEx, Johnson led the successful implementation of over 200 global trade lanes transporting over 5 billion dollars of biopharmaceutical product.

Johnson earned his degree in molecular biology and biotechnology from Florida Atlantic University in 2003. He and his wife currently reside in Hollywood, Florida. He holds a first degree black belt in Tae Kwon Do and enjoys reading, cooking and traveling.

Dina Bunn Head of Operations & IT

Dina Carmignani-Bunn joined LifeConEx as Director of the Life Science Service Center and IT in September 2007. Under her leadership, LifeConEx introduced its proprietary IT Platform LifeTrack and established a monitoring team based in India, allowing the company to handle steady double-digit growth while better serving its customers’ needs for timely and accurate information. Since April 2010, Carmignani-Bunn is also responsible for the business development and implementation team as Head of Operations & IT, and is currently involved in developing the next generation system LifeTrack 2.0.

Carmignani-Bunn’s career prior to joining LifeConEx spans several functions over more than twenty years at Lufthansa German Airlines in the areas of finance and accounting, controlling, quality management, and most recently IT service delivery at various locations throughout the US, South America and Lufthansa Cargo’s headquarters in Frankfurt, Germany.

Nina Heinz Head of Quality

Nina Heinz is Head of Quality for LifeConEx and is an IATA strategic member. Heinz has been working closely with the IATA Time & Temperature Task Force in the establishment of the IATA Chapter 17 of the Perishable Cargo Regulations. In addition, she is a certified IATA instructor and played an important role in establishing the IATA Pharmaceutical Cargo Handling 3-day course. Heinz is also a member of Rx360, an international consortium of pharmaceutical companies and suppliers that aims to develop and implement a global quality system.

As an IRCA Certified Quality Auditor, Heinz is very active in performing audits at airports worldwide in coordination with the respective airport, handling and airline partners to assess their capabilities in handling temperature-sensitive life sciences shipments.

Prior to her involvement with LifeConEx, Heinz was with Lufthansa Cargo for several years as a global account manager for key pharmaceutical customers in Europe. She was one of the founding members of the Pharma Logistics Forum and was closely involved in the coordination of the annual conferences.

Heinz is German and she completed her studies in Boston, Massachusetts, US. She resides in Paris with her husband and two children.

About UsAbout UsLifeConEx DNAPartnershipsLeadershipContact Us

C
C Service C Service (Critical) When your first ship date is rapidly approaching and a working Standard Operating Procedure (SOP) is adequate for your type of product, LifeConEx C Service is the way to go. A working SOP and incident report are available. The C Service requires a minimum of 3 business days for implementation prior to the first ship date of your product. Calibration Calibration The tuning of an instrument according to a standard value. Calibration Verification Calibration Verification The act of confirming that a device or instrument is properly calibrated. Cardboard Cardboard A thick paper-based material. Carrier Carrier Provides transport services for traveling passengers and/or freight. Carry Paks Carry Paks A thermal container system with a handle that makes personal transportation easy and efficient. Ideal for medical samples, food, perishables, or valuables (also called carry packs). CFC CFC Chlorofluorocarbons - a refrigerant known to cause depletion of atmospheric ozone. CFR CFR Code of Federal Regulations CFR (21) Part 11 CFR (21) Part 11 Federal regulations stating that electronic records and signatures are considered equivalent to paper records. cGMP cGMP Current Good Manufacturing Practices Chamber Controller Chamber Controller An electronic instrument used to regulate the ambient temperature of an environmental chamber.	Change Control Change Control Process, authorities, and procedures used for all computerized or system data changes. Change control should be in place to ensure that changes are reviewed for potential impact upon the quality of the product or upon the quality system. Source: WHO TRS 937 Annex 5, 12.2. EU GMP Part 1, 8, ICH Q10 3.2.3 Chart Recorder Chart Recorder An electronic instrument that records the ambient temperature of an environmental testing chamber. Chilled Chilled Usually products in this category need to be stored and distributed at 2° and 8° C. The building or fridge should be alarmed so that potential deviations can be acted upon. Appropriate insulation and access control should be in place so that temperature fluctuations do not occur. Source: EU GMP 1 3.3, PIC/s PE009-7 Part I 3.3, HQMS AA-4 08 Clinical Investigation Clinical Investigation Any experiment in which a drug is administered or dispensed to or used involving one or more human subjects. For the purpose of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice. (FDA Regulation 312.3, Investigation New Drug Application). Clinical Research Clinical Research Patient oriented research including epidemiology (retrospective, cross-sectional, or prospective study of disease(s) in populations), and studies of behaviors, outcomes, and health services. Clinical Site Clinical Site A clinical site is a medical facility staffed with a clinical investigator (MD) and qualified for performing clinical research. To be qualified as a clinical site, strict regulations are to be adhered to. Clinical Trial Clinical Trial Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or pharmacodynamic effects of an investigational product with the object of determining safety and/or efficacy." (ICH GCP, International Conference on Harmonization / WHO Good Clinical Practice Standard) Clinical Trial Volunteer Clinical Trial Volunteer Individuals who are participating in a clinical research study. CO2 Emissions CO2 Emissions Carbon dioxide (CO2) is emitted in a number of ways. It is emitted naturally through the carbon cycle and through human activities like the burning of fossil fuels. Cold Cold Any temperature not exceeding 8° C; (46° F). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2° C; and 8° C; (36° and 46° F). (USP 797) Cold Chain Analytics Cold Chain Analytics A solution that drives the day-to-day retrieval, storage, compilation, analysis and reporting of your cold chain data. Temperature data, gathered from your cold chain, is translated into pertinent, meaningful information that allows managers to reduce costs, improve quality and increase profitability. Cold Chain Management Cold Chain Management Management of all phases of the cold chain, including products in transit, in process, in storage, and in display.	Cold Chain Network Cold Chain Network See Cold Chain. Cold Chain Packaging Consultant Cold Chain Packaging Consultant An individual with expertise in the area of cold chain packaging. Cold Chain Product Cold Chain Product A product that is temperature sensitive. Cold Chain Solutions Cold Chain Solutions Are designed to achieve the goal of consistently having temperature-sensitive medicinal products in the right place, at the right time, and in the right condition, through the integration of monitoring, and tracking and tracing, with an emphasis on driving measurable process improvement from the information. Cold Chain Storage Consulting Cold Chain Storage Consulting Advice from an expert in the design and application of cold chain solutions. Cold Chain Cold Chain Refers to a time and temperature controlled transportation for temperature sensitive products from the manufacturer to the end user. Source: PDA PCCIG EU Branch Lead, Berlin PDA 2010 Conditioning Conditioning see Pre-conditioning. Conductive Heat Transfer Conductive Heat Transfer Having the quality or power of conducting heat or electricity or sound; exhibiting conductivity. Consignee Consignee In a contract of carriage, the consignee is the person to whom the shipment is to be delivered to whether by land, sea or air. Container Container The material employed in the packaging of a pharmaceutical product. Containers include primary and secondary containers. Containers are referred to as primary if they are intended to be in direct contact with the product. Secondary containers are not intended to be in direct contact with the product. Source: WHO TRS 937 Annex 5 Contamination Contamination The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter during manufacturing, sampling, packaging or repackaging, storage or transport. Source: WHO TRS 937 Annex 5 Contingency Planning Contingency Planning One of the fundamental aspects of LifeConEx Process Management. Multiple storage and distribution options are built into the cold chain to ensure an uninterrupted process which maintains a given temperature range.	Controlled Ambient Temperature Controlled Ambient Temperature Some regions and products need both monitoring and control because of severe temperature fluctuations. Controlled ambient is understood as between 15C and 30C and needs to be validated. Source: EU GMP Part 1 3.19, HQMS AA-4 08, Pharma 2001: 267: 128-131 Controlled Drug Storage Controlled Drug Storage An additional license is required to store controlled drugs. A separate secure storage area should be provided which is designed to meet local regulatory security requirements. Source: HQMS AA4-10, INCB Yellow & Green Lists Controlled Room Temperature (CRT) Controlled Room Temperature (CRT) A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77° F); that results in a mean kinetic temperature calculated to be not more than 25C; and that allows for excursions between 15°C and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40°C are permitted as long as they do not exceed 24 hours. Spikes above 40°C may be permitted if the manufacturer so instructs. Articles may be labeled for storage at "controlled room temperature" or at "up to 25°C", or other wording based on the same mean kinetic temperature. The mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the non-isothermal effects of storage temperature variations. (Source: USP 797) Convective Heat Transfer Convective Heat Transfer Caused or accomplished by convection; as a convective discharge of electricity. Cool Cool Any temperature between 8° C; and 15° C; (46° and 59° F). An article for which storage in a cool place is directed may, alternatively, be stored and distributed in a refrigerator, unless otherwise specified by the individual monograph. (Source: USP 797) Corrective Action Corrective Action Is taken to eliminate the cause of a detected non-conformity or other undesirable situation. Corrective Action Preventive Action (CAPA) Corrective Action Preventive Action (CAPA) focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action). To ensure that corrective and preventive actions are effective, the systematic investigation of the failure incidence is pivotal in identifying the corrective and preventive actions to be undertaken. A formal written response must be made by the facilities audited on all observations within 30 days. CAPA is part of the overall quality management system (QMS) at LifeConEx called - LifeControl.Source: Good Manufacturing Processes, ISO 13485:20038.3, ICH Q10 3.2.2, FDA 21 CFR 820.90 Corrugate Corrugate Refers to the alternating ridges and grooves in a cardboard carton. Counterfeit Medication Counterfeit Medication Product or cosmetic which is deliberately and fraudulently mislabeled with respect to identify and/or source. Counterfeiting can apply to both branded and generic products/cosmetics and may include products / cosmetics with the correct ingredients or with wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging. Source: Guidelines for Good Distribution Practice Cross-contamination Cross-contamination Contamination of a starting material, intermediate product or finished product with another starting material or product during production. Source: Source: WHO TRS 937 Annex 5 Customs Customs Each country's department that reviews in-coming materials, including clinical trials materials. The area at a port, airport, or border where baggage and freight are examined for duty status. Care must be taken with temperature sensitive materials and prior notification should be provided so that speedy clearance can be obtained and if necessary the correct storage conditions provided for at the point of entry. Source: EU GDP (94/C – 63/03) 21, WHO TRS 937 Annex 5 18.6

D
Dangerous Goods Dangerous Goods Are defined as articles or substances which are capable of posing a risk to health, safety, property or the environment which meet the criteria of one or more of nine UN hazard classes and, where applicable, to one of three UN Packing Groups according to the provisions of Section 3 of the International Air Transport Association. Source: IATA Dangerous Goods Regulations 50th Edition Data Acquisition Units (DAU) Data Acquisition Units (DAU) A calibrated device that logs data acquired from an electronic unit. Data Logger Data Logger An in-transit temperature recorder that measures temperature during a specified time period (also called a digital data logger, data monitor, temperature data logger, in-transit temperature recorder). Denaturation Denaturation Is a process in which proteins or nucleic acids lose their tertiary structure and secondary structure by application of some external stress or compound, such as heat. If proteins in a living cell are denatured, this results in disruption of cell activity and possibly cell death. Denatured proteins can exhibit a wide range of characteristics, from loss of solubility to communal aggregation. Design Development/Design Evaluation (Pre-qualification) (n=1) Design Development/Design Evaluation (Pre-qualification) (n=1) Design phase in which shipping systems (shipping containers, insulation, refrigerants) are tested to evaluate its performance. Design Evaluation (DE) or Pre-qualification Testing (PQ) Design Evaluation (DE) or Pre-qualification Testing (PQ) A detailed evaluation, and development of a thermal package design that is tested for its performance under simulated conditions.	Design Evaluation Design Evaluation A detailed review of an existing shipping container system. Deviation Deviation Any quality event with potential impact on product quality which requires an investigation which includes the following events Product, packaging or labeling mix-up involving the product Potential counterfeit product(s) Probable or known contamination of a product with another product, extraneous foreign material or micro-organisms. Batches subject to a major malfunction of equipment or a facility utility system including HVAC, water, sprinkler, plumbing, fire protection, and electrical. Batches subject to natural disasters or acts of God such as flooding, fire, earthquake, lightning strike. Batches requiring a formal investigation for reconciliation discrepancy Product stored outside the established environmental storage conditions (e.g. temperature and humidity). Non-conformance with applicable laws and regulations. Source: WHO TRS 937 Annex 5 Die-Cut Die-Cut A process by which a box is cut to create a customized product. Dimensions Dimensions Description of an object in physical terms (e.g., length x width x depth, or length x width x height). Discrepancy Discrepancy An inconsistency between facts or sentiments. For example, they found a discrepancy between the first set of temperature data logger results and the second. Throughout the cold chain, physical actions must be consistently be matched with temperature readings to determine discrepancies. Distribution Distribution The division and movement of pharmaceutical products from the premises of the manufacturer of such products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via storage and/or health establishments. Source: WHO TRS 937 Annex 5	Distribution Process Distribution Process The process by which product moves from the point of manufacturing to the end user. This may include 3PL (third party logistics), freight forwarders, freight consolidators, wholesalers and expedited shippers. Distribution Temperature Distribution Temperature Specified temperature at which a product must be distributed. Double-blind Trial Double-blind Trial In a double-blind or double-masked study neither the participants nor the study staff know which participants are receiving the experimental treatment and which ones are receiving either a standard treatment or a placebo. These studies are performed so that neither the patients nor the doctors expectations about the experimental drug can influence the outcome. Double Wall Corrugated Board Double Wall Corrugated Board A box made by joining three flat facings and two intermediate corrugated parts. This box is usually stronger than a single wall corrugated box. DRA DRA Drug regulatory authority: National authority responsible for the regulation of medicinal products. Source: WHO TRS 937 Annex 5	Drug product Drug product A finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo. Source: WHO TRS 937 Annex 5 Dry Ice Dry Ice A refrigerant that is solid carbon dioxide, which sublimates to a gas at very cold temperatures. Dry ice is used as a pharmaceutical coolant in insulated/thermal packaging. Dry Place Dry Place The term "dry place" denotes a place that does not exceed 40% average relative humidity at Controlled Room Temperature or the equivalent water vapor pressure at other temperatures. The determination may be made by direct measurement at the place or may be based on reported climatic conditions. Determination is based on not less than 12 equally spaced measurements that encompass either a season, a year, or, where recorded data demonstrate, the storage period of the article. There may be values of up to 45% relative humidity provided that the average value is 40% relative humidity. Storage in a container validated to protect the article from moisture vapor, including storage in bulk, is considered a dry place. There are no hard and fast temperature or humidity requirements for cleanrooms. Ideally, the controlled compounding rooms should be 66F +/-2 F to ensure employee comfort when fully garbed. Relative humidity (RH) recommendations should be between 30 and 65 % RH. Dunnage Dunnage Padding used to fill empty space in a shipping container. Duration Duration A length of time, i.e., a 24-hour minimum post stabilization or until stabilization occurs at the specified temperature.

E
E-Pedigree E-Pedigree An electronic record that traces the ownership and transactions of a prescription drug product as it moves among various trading partners – from the manufacturer to the pharmacy, hospital or other healthcare entity. The primary purpose of an e-pedigree is to protect consumers from contaminated medicine or counterfeit drugs. WHO TRS 937 Annex 5 Efficacy Efficacy The ability to produce a desired outcome. EMEA EMEA European Medicines Agency - is a European agency for the evaluation of medicinal products, roughly parallel to the U.S. Food and Drug Administration (FDA). End-to-End End-to-End End to end solutions designed to process the logistics requirements from manufacturer to wholesaler/distributor to retailer. Environmental Chamber Environmental Chamber A thermally isolated chamber typically capable of maintaining temperatures within a minimum and maximum (e.g., -30°C to 85°C) by means of a programmable controller. A quality environmental chamber is one that is capable of maintaining its controlled temperature throughout the entirety of the chamber without drop offs or hot pockets. Additionally, a quality chamber must be draft free, preventing direct air blowing upon the tested product.	EPA EPA Environmental Protection Agency - is an agency of the federal government of the United States charged with protecting human health and the environment, by writing and enforcing regulations based on laws passed by Congress. EPS EPS Expanded polystyrene - a lightweight, cost effective, cushioning insulating material used in packaging for temperature-sensitive goods. EFGCP EFGCP European Forum for Good Clinical Practice - is a European think tank which works on the ethical, regulatory, and scientific framework of clinical research in Europe. Eucomed Eucomed Is the representation of the medical technology industry in Europe. Source: WHO TRS 937 Annex 5 Eutectic Mixture Eutectic Mixture A mixture of two or more substances with a melting point lower than that of individual substances.	Eutectic Point Eutectic Point A eutectic point is the temperature that is maintained as the mixture of Phase Change Materials transforms from solid to liquid (or vice versa). Excipient Excipient A substance or compound, other than the active pharmaceutical ingredient and packaging materials, that is intended or designated to be used in the manufacture of a pharmaceutical product. Source: WHO TRS 937 Annex 5 Excessive Heat Excessive Heat Any temperature above 40° C; (104° F). (Source: USP 797) Excursion Excursion Deviation from a specified limit. Excursion Limit Excursion Limit A defined allowable deviation from a specified limit.	Expanded Polystyrene (EPS) Manufacturer Expanded Polystyrene (EPS) Manufacturer A company that manufactures EPS. Expiry date Expiry date The date given on the individual container (usually on the label) of a product up to and including which the product is expected to remain within specifications, if stored correctly. It is established for each batch by adding the shelf-life to the date of manufacture. Source: WHO TRS 937 Annex 5 Exposure Exposure The condition of being exposed, uncovered, or unprotected. This represents a deviation to the cold chain. External Temperature Cycle External Temperature Cycle The ambient temperature that the shipping container witnesses for each step of the transit process (packaging, warehouse, transit, etc.). External Temperature Profile External Temperature Profile Refers to the ambient temperature that the shipping container witnesses during its transit process. There are a number of acceptable means by which the ambient profile can be determined (summer highs, winter lows). Please see ATMP for more details.

I
IATA IATA International Air Transport Association - is an international trade body, created over 60 years ago by a group of airlines. Today, IATA represents some 230 airlines comprising 93% of scheduled international air traffic. The organization also represents, leads and serves the airline industry in general. IATA Ch. 17 IATA Ch. 17 the International Air Transport Association (IATA) has added a chapter to the 7th Edition of the Perishable Cargo Regulations effective July 1, 2007. The 23 page Chapter 17 is dedicated to air transportation for temperature-sensitive healthcare products. The purpose of this chapter is to provide information on the factors that affect temperature-sensitive healthcare products and to indicate critical control points in the air transport logistics that can impact these sensitive products and to provide best practices conforming to regulatory agencies requirements. Source: IATA Ch. 17 IATA Time and Temperature Sensitive Label IATA Time and Temperature Sensitive Label The Time & Temperature Sensitive Handling Label usage is specific to the healthcare industry. It was first introduced in Chapter 17 of the 9th Edition of the IATA Perishable Cargo Regulations (effective July 1, 2009), as an optional label to be used in conjunction with a Quality Management System between the shipper, freight forwarder, airline carrier and others in the distribution chain. IATA Time and Temperature Task Force IATA Time and Temperature Task Force The IATA Time and Temperature Task Force (TTTF) is mandated to develop and maintain standards for the procedures, documentation, cargo handling, packaging and acceptance of goods from the health care sector in order to facilitate, improve or maintain the logistics thereof. It shall act as the liaison with all stakeholders from the health care industry or their intermediaries. ICE (Investigation of Carrier Error) ICE (Investigation of Carrier Error) These are carrier-specific investigations undertaken by the LifeConEx Quality team dealing with any potential product deviations (e.g. from controlled temperature, storage conditions, cleaning requirements, or procedure). The root cause of the deviation is determined and corrective actions put in place to prevent re-occurrence.Source: WHO TRS 937 Annex 5, 12.14 – 14.5, FDA 21 CFR 820.198, ISO 13485: 2003 8.3 ICH ICH The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration. The purpose of ICH is to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration. IDE (Investigational Device Exemption) IDE (Investigational Device Exemption) An application to FDA to request permission to conduct human testing of unapproved devices. Immediate Packaging Immediate Packaging The container or other form of packaging immediately in contact with the medicinal or investigational medicinal product. Source: WHO TRS 937 Annex 5	Implementation (linked to implement and implementation) Implementation (linked to implement and implementation) The systematic review and approval of each SOP, trade lane by trade lane, by each respective supply chain partner within what cold chain. These processes are stored in the LifeConEx LifeTrack IT system. Importation Importation The act of bringing or causing any goods to be brought into a customs territory (national territory, excluding any free zone). Source: WHO TRS 937 Annex 5 INCB INCB The International Narcotics Control Board is the independent and quasi-judicial control organ monitoring the implementation of the United Nations drug control conventions. Incident Report Incident Report Inquiry conducted in case of deviation to the LifeConEx Working SOP or Process Map. INCOTERMS INCOTERMS Incoterms or International Commercial terms are a series of pre-defined commercial terms published by the International Chamber of Commerce (ICC) widely used in international commercial transactions. A series of three-letter trade terms related to common sales practices, Incoterms are intended primarily to clearly communicate the tasks, costs and risks associated with the transportation and delivery of goods. Source: WHO TRS 937 Annex 5 IND IND Investigational New Drug INDA (Investigational New Drug Application) INDA (Investigational New Drug Application) An application to the Food and Drug Administration (FDA) by a drug sponsor in which permission is requested for the human testing of the drug product, which is called the investigational new drug. Prior to initiating Phase I for a clinical trial, the applicant must submit a detailed protocol, preclinical data, and investigator credentials. Innovation Innovation The development and introduction of new ideas, goods, and services.	Intermediate Intermediate A material produced during the processing step of an API which must undergo further molecular change or purification before it becomes an API. Source: Guidelines for Good Distribution Practice Intervention Management Intervention Management These are the actions taken by the LifeConEx Life Science Service to address deviations to the implemented SOP. These may include but are not limited to: Offloaded shipments, misrouted shipments, improper documentation, damaged or malfunctioning cool containers, or incorrect temperature settings. Investigational Product Investigational Product A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authori Investigation Report Investigation Report Report conducted by the LifeConEx Quality team which supports the regulatory compliant SOP and release of product in case of deviation to the process. This involves a complete review of each supply chain entities processes when a deviation to the LifeConEx SOP is reported on a trade lane. Corrective and preventive actions are identified and implemented for that SOP covering that trade lane. IPIC IPIC International Pharmaceutical Industry Congress IQ/OQ/PQ IQ/OQ/PQ Installation Qualification, Operational Qualification, Performance Qualification ISO ISO International Organization for Standardization - is the world's largest developer and publisher of International Standards. ISO is a network of the national standards institutes of 162 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO 9001:2000 ISO 9001:2000 The International Organization for Standards' Quality Management System for accreditation of quality control for manufacturers.	ISPE ISPE International Society for Pharmaceutical Engineering ISTA ISTA International Safe Transit Association - provides programs, services and activities that assist in packaged-product distribution. ISTA 1A ISTA 1A ISTA's basic requirements for fixed displacement vibration and shock testing. ISTA 2A ISTA 2A ISTA's basic requirements for atmospheric conditioning, compression, fixed displacement or random vibration and shock testing. ISTA 5B ISTA 5B ISTA's focused simulation guide for thermal performance testing of temperature controlled packaging and thermal boxes. ISTA 7D ISTA 7D Is a development test to evaluate the effects of external temperature exposures of individual packaged products shipped through a parcel delivery system. ISTA 7E ISTA 7E Refers to a set of thermal shipping profiles. The 7E Converter is a program that allows companies to enter their current data, click a button on their computer, and receive a prediction of thermal performance of their ISC against the new profiles.

P
Packaging Type Packaging Type (linked to Packaging Type and Packaging Technologies or Packaging Technology) Three basic types of cold chain packaging systems are available: active, passive and hybrid. Packaging Selection Criteria Packaging Selection Criteria When selecting the best packaging for your product, the following factors must be analyzed: active versus passive, size and shape, payload, thermal test profile, test equipment calibration, position and type of refrigerant, package equilibration period. Source: PDA PCCIG EU Branch Lead, Berlin PDA 2010 Packout (Pack-out) Packout (Pack-out) The steps and procedures necessary to assemble a shipping container with its refrigerants, buffering materials, and product payload. Pad Pad A material used to add protection and minimize shock between layers of products within shipping container, or between containers (e.g., corrugated or solid fiberboard, EPS). PAHO PAHO The Pan American Health Organization is an international public health agency with more than 100 years of experience in working to improve health and living standards of the countries of the Americas. It serves as the specialized organization for health of the Inter-American System. It also serves as the Regional Office for the Americas of the World Health Organization and enjoys international recognition as part of the United Nations system. Pallet Shipper Pallet Shipper Thermal shipping unit designed to hold an entire pallet. Passive packaging Passive packaging Passive packaging commonly use phase change materials (PCM) such as water/ice or dry ice. These shipping systems are the most basic and cost effective. Passive Thermal System Passive Thermal System See Passive Packaging. Patient Patient A patient is any recipient of medical attention, care, or treatment. The patient is most often ill or injured and in need of treatment by a physician, veterinarian or other health care professional, although one who attends a physician's visit for a routine check-up may also be viewed as a patient. Payload Payload The contents of an inner container (e.g., pharmaceutical products). PCM PCM Phase Change Material - A material that changes phases from solid to liquid (or liquid to gas) at a single temperature. Phase Change Materials are either salt or organic based and are capable of changing phases from below -50°C to over 100°C. PDA PCCDG PDA PCCDG PDA Pharmaceutical Cold Chain Discussion Group - is an informational exchange group that educates its members on global shipping and distribution of temperature-sensitive medicinal products through trade and regulatory organizations. This group also develops guidelines and proposes standards for validation of shipping and distribution of the products.	PDA PDA Parenteral Drug Association PET PET Polyethylene (PET) - A plastic material used in the manufacture of some gel packs. Pharmaceutical product Pharmaceutical product Any medicine intended for human use or veterinary product administered to food-producing animals, presented in its finished dosage form, that is subject to control by pharmaceutical legislation in both the exporting state and the importing state. WHO TRS 937 Annex 5 Pharmaceutical Industry Pharmaceutical Industry The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices. They are subject to a variety of laws and regulations regarding the patenting, testing and ensuring safety and efficacy and marketing of drugs. Pharmacology Pharmacology Is the branch of medicine and biology concerned with the study of drug action. Pharmacovigilence Pharmacovigilence Is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbals, and traditional medicines with a view to identify information about potential new hazards and prevent harm to patients. WHO TRS 937 Annex 5 Phase I Clinical Trial Phase I Clinical Trial A clinical trial that is performed to determine how the drug affects the human body, how much medicine is safe, and how the drug should be administered. Phase I trials may involve a small number of patients (usually 15 to 30) with the disease under study or healthy human volunteers. Phase II Clinical Trial Phase II Clinical Trial A clinical trial that provides information about how well a drug works, and generates more information on its safety and benefit. Generally 100 to 200 take part in Phase II trials. Phase III Clinical Trial Phase III Clinical Trial A clinical trial conducted to determine whether the current treatment practice is the best way to treat a patient, or better treatment would be provided by a new drug treatment. Phase III trials compare a new drug, combination of drugs, device, or procedure with a current standard of treatment. Phase III clinical trials involve approximately 1,000 to 3,000 people nationwide or worldwide. Phase IV Clinical Trial Phase IV Clinical Trial A clinical trial in which further evaluation is conducted on a drug has received approval from the FDA. Phase Change Phase Change A change from one physical form to another at a specific temperature.	Polyurethane Insulated Panel Polyurethane Insulated Panel A flat piece of polyurethane designed to fit as a panel in a temperature-sensitive container (also called rigid thermal protection, rigid foam board insulation, rigid polyurethane foam sheet, rigid urethane foam, foam insulation panel, panel sheet insulated containers, expanded packaging polystyrene). Protection from Freezing Protection from Freezing Where, in addition to the risk of breakage of the container, freezing subjects an article to loss of strength or potency, or to destructive alteration of its characteristics, the container label bears an appropriate instruction to protect the article from freezing. (Source: USP 797) Pre-conditioning Pre-conditioning Temperature stabilization of a material per requirements (e.g., freezing a gel pack) prior to pack out. Pre-qualification Testing (PQ) or Design Evaluation (DE) Pre-qualification Testing (PQ) or Design Evaluation (DE) The initial development of a thermal package design based on the needs assessed by the user. Pre-qualification (linked to pre-qualified) Pre-qualification (linked to pre-qualified) A preliminary study, which is generally the first test taken to ensure that a package will meet the objectives in the Final Qualification study. Pre-Test Conditioning Pre-Test Conditioning Storage temperature prior to packout and shipment. Preventive Action Preventive Action Is different from corrective action in that corrective action is taken to prevent reoccurrence whereby preventive action is taken to prevent occurrence. There are two aspects to preventive action. The first is risk assessment and the second is continuous improvement. Primary Packaging Primary Packaging The packaging having direct contact with a medicinal product. WHO TRS 937 Annex 5 Process Mapping Process Mapping LifeConEx analysis and design of each cold chain process per individual trade lane. Access to LifeConEx LifeTrack Shipment Tracking Module for Process Updates is a part of this Expedited (X service). Product Product A drug in a dosage unit or otherwise, for use wholly or mainly by being administered to one or more human beings or animals for a medicinal purpose; or a drug to be used as an ingredient of a preparation for medicinal purpose. Source: Guidelines for Good Distribution Practice Product Recall Product Recall Is a process for withdrawing or removing a pharmaceutical product from the pharmaceutical distribution chain because of defects in the product or complaints of serious adverse reactions to the product. The recall might be initiated by the manufacturer, importer, wholesaler, distributor, or responsible agency. Especially with respect to counterfeit medicines emergency recall procedures might apply.WHO TRS 937 Annex 5 Product Stability Product Stability The capacity of a drug substance or drug product to remain within specification established to ensure its identity, strength, quality, and purity. Source: FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products	Product Stability Profile Product Stability Profile Throughout a study, a product stability profile is created which shows the behavior of substance over time when correctly stored or transported.Source: FDA Guidance for Industry: Analytical Procedures and Methods Validation Protocol Protocol Detailed instructions and requirements used in the execution of a test and/or procedure (e.g., qualification testing). Prototype Prototype A full-scale model or example of a new product prior to its final design. PUR PUR Rigid Polyurethane containers for the safe shipment of temperature-sensitive products.

J
Japan Ministry of Health Japan Ministry of Health This ministry provides regulations on maximum residue limits for agricultural chemicals in foods, basic food and drug regulations, standards for foods, food additives, etc.

V
Vaccine Vaccine A biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins. The agent stimulates the body's immune system to recognize the agent as foreign, destroy it, and "remember" it, so that the immune system can more easily recognize and destroy any of these microorganisms that it later encounters. Vaccine Trial Vaccine Trial A clinical trial to study the efficacy of a vaccine. Validation Validation Action of proving and documenting that any process, procedure, or method actually and consistently leads to the expected results. Source: FDA Guidelines on General Principles of Process Validation	Vehicle Vehicle Refers to trucks, vans, buses, mini-buses, cars, trailers, aircraft, railway carriages, boats and other means which are used to convey pharmaceutical products.WHO TRS 937 Annex 5 VIP VIP Vacuum Insulated Panels offer high R-value insulation.

A

Acceptance Criteria

Active Packaging

Active Thermal System

Adhesive

Allowable Excursions

Ambient Monitored

Ambient Temperature

Anvisa

API

ASTM

ASTM D-3101

ATMP

Audit

B

Bag

Barrier

Batch

Batch number

Benchmark

Bill of Materials (BOM)

Biological

Biotechnology

Biopharmaceutical (linked to Biopharmaceutical and Biopharmaceuticals)

Biosimilar

BLA (Biologic License Application)

Blinding

Bricks

Broker

C

C Service (Critical)

Calibration

Calibration Verification

Cardboard

Carrier

Carry Paks

CFC

CFR

CFR (21) Part 11

cGMP

Chamber Controller

Change Control

Chart Recorder

Chilled

Clinical Investigation

Clinical Research

Clinical Site

Clinical Trial

Clinical Trial Volunteer

CO2 Emissions

Cold

Cold Chain Analytics

Cold Chain Management

Cold Chain Network

Cold Chain Packaging Consultant

Cold Chain Product

Cold Chain Solutions

Cold Chain Storage Consulting

Cold Chain

Conditioning

Conductive Heat Transfer

Consignee

Container

Contamination

Contingency Planning

Controlled Ambient Temperature

Controlled Drug Storage

Controlled Room Temperature (CRT)

Convective Heat Transfer

Cool

Corrective Action

Corrective Action Preventive Action (CAPA)

Corrugate

Counterfeit Medication

Cross-contamination

Customs

D

Dangerous Goods

Data Acquisition Units (DAU)

Data Logger