“Exelsius and Tony Wright’s in-depth knowledge and experience were of great value to the carrier and his flexible approach was a key factor in the success of the design stage. We have seen significant growth from our Constant Climate service, supported by positive feedback from clients across our network.”
“At Panalpina know that we are in a people business and therefore put great emphasis on training. Having qualified staff is a must in a GDP environment and Exelsius has been a key partner in supporting us in achieving our goal. The training program of Exelsius is complete and the methods used, get our people motivated and interested which results in a positive outcome.”
“Exelsius is always striving for operational excellence and achieving the desired results. Tony Wright has an excellent knowledge of the Air Cargo Business and the Air Cargo Pharma Requirements in particular. I would call him “THE” Pharma specialist in the Air Cargo industry. His support in the launch of our Pharma2World product was essential from concept phase up to implementation.”
“From providing initial strategic direction, through to the creation of the company’s business plan and on-going day-to-day support of the management team, Exelsius’ sector knowledge and impartiality have been valuable assets to the company.”
“In my whole career I have never attended a training course of such quality, expertise and intensity. It was a real pleasure and joy participating.”
“Tony and the Exelsius team were brought in to take us through the GDP Certification process from beginning to end – they had the experience and knowledge to guide and support dnata through the audit processes all the way to closing the gaps and finally achieving GDP certification by the Singapore Health Sciences Authority. Mark Edwards, Dnata CEO added, ”We have learned much from this working partnership and have benefitted through improved and enhanced processes at Coolchain. The handling team also further enhanced their knowledge and skill base while working with Tony and Exelsius to continually improve service at Coolchain,”
Let the knowledge, skills and expertise of Exelsius help your organization meet the needs of the Healthcare logistics sector
Whether you are a manufacturer seeking to identify or mitigate any of the Critical Control Points in your distribution chain, or a logistics provider looking to serve the healthcare sector through GDP compliance, Exelsius will work with your team to develop solutions from start to finish. Our expertise in creating the right logistics and product related environment for temperature-sensitive life science and pharmaceuticals has been used my many of the world’s leading airlines, logistics service providers and pharmaceutical companies.
The Exelsius Pharmaceutical Qualification Programme (PQP) – Become Independently GDP Certified to International requirements
This programme has been developed specifically for the life science and pharmaceutical logistics sector and includes a range of activities that will allow you to become GDP compliant, in one inclusively priced package. Our team of experts will work with you to create:
- An initial Gap Analysis versus the requirements of GDP
- Facility assessment
- A written Compliance Implementation Plan
- GDP Quality Management System development
- SOP & Service Level (Quality) Agreement development
- Vendor assessment/benchmarking
- A fully integrated Training Plan and GDP Certified Training
With over half of the value of healthcare products being moved by air, shippers will be seeking the most compliant GDP providers and regulators will be looking for ever higher standards. With the Exelsius Pharmaceutical Qualification Programme (PQP) you can be ready to meet those expectations.
Exelsius has worked with many of the world’s leading airlines, logistics service providers and Healthcare companies in their desire to offer improved or newly launched services, facilities and compliant processes designed to meet your organizations objectives and the requirements of cGDP. Working with and coaching your team, we will develop an inclusive project plan that implements measurable results and allows your business to sustain its objectives.
Training – an essential part of the GDP compliance process
The need for trained staff in the handling of temperature-sensitive pharmaceutical products has become an established requirement of every Good Distribution Practice (GDP) publication. As the logistics process for these highly sensitive commodities becomes more complex, it is essential that all staff involved in their distribution have been properly trained. It’s simply about patient safety.
Exelsius has become renowned for it’s certificated training and with over 2500 students from more than 180 companies having attended a variety of its courses, we can ensure that your personnel are trained to GDP standards. And because we teach not just individual roles, but about the end-to-end supply chain process, students gain that all-important understanding of the impact they can have on a successful supply chain.
The Exelsius Two-Day workshop
This workshop allows students to gain a certificated understanding of GDP requirements and is particularly useful for those taking their first steps into Good Distribution Practice compliance in the healthcare logistics sector.
Experienced tutors will provide a particular focus upon regulatory guidance including:
- The revised EU Guidance (EU343/01), USP1079/1083
- IATA Chapter 17 / Temperature Control Regulations
Through case studies, team exercises and practical demonstration, students will gain a thorough understanding of the complex world of international healthcare logistics including:
- Understanding the supply chain process from R & D to product launch
- Audits, Risk Management and CAPA in the logistics process
- Temperature management, mapping and data recording
- Passive and active transportation solutions- practical use of materials and containers
- Packaging qualification and Route Qualification
- Quality Management Systems in the logistics process
The Exelsius one-day ‘GDP Refresher’ workshop
Keep your staff up-to-date and regularly trained to GDP requirements with the Exelsius one-day programme. Covering all of the essential elements of GDP and the application of the latest regulations, each workshop is custom-designed to the needs of your staff and will provide you with the necessary compliance certification. It will also satisfy the requirements of your Quality Management System (QMS).
Both the Two-Day and One-Day programmes are generally held on-site at your premises. This results not only in cost reduction and minimal disruption, but most importantly allows students to relate their everyday experiences to the requirements of Good Distribution Practice in a team-building environment.
Exelsius GDP Training – an investment in knowledge that always pays the best dividend.
Good research avoids costly mistakes – Exelsius can help
The world of healthcare logistics remains increasingly complex. Driven by an ever-growing range of international GDP regulation together with country-specific rules regarding product importation, it is not an easy task for your business to remain compliant and competitive in an international environment where patient safety is paramount.
And if you are considering entering the world of temperature-sensitive logistics, you need the right amount of market research to allow your business to take decisions that make you responsive to customers’ needs and increase profits.
Exelsius can help you understand these complexities and meet the regulatory expectations of Good Distribution Practice within the temperature-sensitive distribution process.
We can provide you with an independent analysis that will support your business decisions including competitor activity, market trends in innovation, technology and recommended temperature-controlled packaging and transportation solutions.
Our experts are regularly involved in writing white papers and case study’s that can highlight your services and gain you that market edge versus your competitors.
Contact us to keep you one step ahead.