Author: Amy Shortman

Certified Excellence: ASC Associates Ltd Pioneers GDP Program for Pharmaceutical Logistics in Partnership with PCSC

New Jersey, USA, 4th April 2024 – ASC Associates Ltd, a leading provider of supply chain solutions, is thrilled to announce the launch of its highly anticipated Good Distribution Practice (GDP) Program. This innovative initiative, developed in collaboration with the HDA’s Pharmaceutical Cargo Security Coalition (PCSC), marks a significant milestone in enhancing supply chain integrity and efficiency within the pharmaceutical industry. The program is designed to strengthen the integrity of the pharmaceutical supply chain and set new industry standards. ASC Associates Ltd, a trusted name in GDP program design and training, is the driving force behind this accreditation, ensuring that participants meet recognized operational and training criteria.

The GDP Accreditation was unveiled at the HDA’s PCSC Educational Seminar in Whippany, N.J., on 4th April 2024. It offers a comprehensive assessment process that aligns with European standards and endorsed criteria from the PCSC. Companies that complete the rigorous training phase receive accreditation that is valid for two years, with an option for renewal, ensuring ongoing compliance and proficiency.

DeSpir Logistics, a leading 3PL Logistics Provider, has not only completed the program but has also become the first recipient of the accreditation. This remarkable achievement serves as a beacon of inspiration, demonstrating the efficacy of the program in aligning existing supply chain security and quality best practices.

“GDP Accreditation” is a groundbreaking initiative that is poised to transform the transportation and logistics sector in the United States. This program offers companies a unique opportunity to improve their supply chain practices, which can significantly enhance their operations and service offerings. According to Amy Shortman, the Founder and EVP of Product Marketing at ASC, pharmaceutical companies require high trust when entrusting valuable cargo to a transportation company. As a result, they tend to prefer working with logistics partners that adhere to the best supply chain compliance and security practices and have been certified by an independent entity. Extending the pharmaceutical companies’ quality standards downstream to logistics partners, creates an invaluable system of trust and efficiency in the industry.

Henry Moran, COO of ASC Associates Ltd and advisory board member of PCSC, praised the collaborative effort behind the program’s development and its potential to enhance supply chain resilience. Moran commended DeSpir Logistics for its pioneering role and highlighted the programme’s broader impact on industry stakeholders.

ASC Associates Ltd’s GDP Program offers unparalleled training and accreditation for companies seeking to elevate their supply chain practices and safeguard product quality and integrity. For more information, please visit hda-and-pcsc-announce-launch-of-gdp-accreditation-program.

Change is afoot.

9 years ago, I set up ASC. It was born out of a love of working within logistics, combined with the flexibility to be able to care for three little humans that my husband and I had brought into the world.

It has been an amazing journey with some great clients. My husband Henry Moran joined my venture in 2015 and we have worked together for the past 4 years. During that time we have developed a company that has supported all the major stakeholders within high-value and pharmaceutical logistics, providing services such as Supply Chain Vulnerability Assessments, GDP Audits/Health Checks and Supply Chain Security Audits. We have also project managed the implementation of a global QMS for a 3PL, developed our own classroom and online training courses such as,  ‘GDP for Logistics‘ and ‘Falsified Medicines & Supply Chain Security’ specifically aimed at the Logistics Industries, and supported airlines and 3PLs in obtaining their WDAs amongst many other projects. We have been fortunate enough to have amazing Associates, such as Tom Cochrane, whose experience and knowledge have strengthened our team, and developed some great partnerships.

This will be my last week with ASC as I have been offered an incredibly exciting opportunity which will be announced publicly very soon. Henry Moran will continue to develop ASC, taking it from strength-to-strength, and will ensure ASC’s clients are well looked after. I know that ASC is in very capable hands.

I would like to take this opportunity to thank all those who have supported me and ASC over the past 8 years. I am staying within this industry, so don’t worry I won’t be going anywhere.

Keep an eye out for my new adventure announcement.

Amy ShortmanASC Amy Shortman CEO

 

ASC partner WCA Academy for GDP & Perishable Training in Barcelona.

 

ASC are delighted to be partnering the WCA Academy at the 5th annual WCA Speciality Logistics Fair in Barcelona, where we will be delivering our GDP and GDP refresher courses. We will also be launching, in partnership with the WCA Academy, the Perishable Gold Standard Training course for perishable logistics compliance.

WCA Speciality Logistics Fair,  Crowne Plaza, Barcelona, Spain from 14th – 17th June 2019.

 

 

ASC to present at 2019 HDA PCSC Educational Seminar, Novartis, N.J, USA.

ASC will be presenting on 9th May at 09:00 on the subject of ‘Demystifying Good Distribution Practice (GDP) Compliance’

‘For the past 10 years, Good Distribution Practice (GDP) has become something of a buzzword when discussing best practice within the pharmaceutical logistics industry. However, there remains a vast amount of confusion over what this means, especially when it comes to which guidelines and licenses apply to each part of the supply chain. Through case studies, learn more about GDP and its value in the logistics industry.’

The HDA Pharmaceutical Cargo Security Coalition (PCSC) Educational Seminar brings together those within healthcare, as well as many other industries, that ship and store sensitive, high-risk/high-value products — anywhere in the world. Held annually since 2006, this supply chain security educational event provides interactive instruction, with both indoor and outdoor activities, as well as case-study discussions. Attendees are introduced to government law enforcement and regulatory personnel (and vice-versa) to enhance knowledge of supply chain security best practices.

Seminar topics include:

  • The technology surrounding shipment monitoring/tracking;
  • The sharing of supply chain intelligence;
  • Cyber supply chain security; and,
  • Familiarization with like or similar industry supporting associations.

May 8 to 9, 2019 | Novartis Corporate Headquarters, East Hanover, N.J.

For further details and registration please click here.

 

PHARMA SECURITY WORLD 2019 ”ANTI-COUNTERFEITING, DRUG SERIALIZATION AND SUPPLY-CHAIN CONFERENCE”

On 19th/ 20th March 2019 in London, UK Corvus Global Events hosted the 2nd Annual Pharma Security World 2019 – Anti-Counterfeiting, Drug Serialization and Supply-Chain Conference, where Pharma industry experts shared various challenges faced, new strategies, case studies and use of innovative ideas and the conference will also offer opportunities to encourage partnerships and collaborations. ASC’s Tom Cochrane shared his 35+ years’ of experience on Supply Chain Security, the important of training those within the supply chain and focused in on the EU’s Falsified Medicine Directive andDrug Supply Chain Security Act (DSCSA)Tom Cochrane ASC Associate

‘The US is driving the path with the approved in 2013. DSCSA guide for end-to-end traceability is extended over a period of 10 years, with expectations sketched throughout the supply chain. The complete supply chain is relied upon to be electronically incorporated and all hubs of traceability to be built up by November 2023. The E.U.’s Falsified Medicines Directive requires drug companies to adopt mass serialization and other anti-counterfeiting measures starting in 2019. Manufacturers who operate in the E.U. will have to add unique identification numbers to the outer packaging of all prescription drugs, and equip containers with tamperproof seals. To guide customers from illicit online drug stores that supply fake medications, the FMD requires approved legitimate Internet drug stores to show a logo distinguishing them as E.U. approved drug retailers.’

The Conference deliberations were on the following themes:

• Understanding and meeting the needs of DSCSA, EU FMD and other global regulations
• Synchrony of the Pharma Industry and professional bodies against counterfeiting
• Tackling pharmaceutical crime – initiatives at multinational, EU and national level
• IP and regulatory enforcement
• Strategies for public awareness and patient protection
• Best practices to protect your brand
• The role of the Internet in aiding the counterfeiters – How to overcome the situation?
• Common Logo initiative in the EU for online pharmacies
• Brand Protection & Securing supply chain integrity
• End to End supply chain visibility
• Developing a sustainable Serialization strategy
• Global enterprise level solutions for anti-counterfeiting
• Integration of track & trace solutions in production and supply chain
• Smart Packaging, Labeling, Artwork, Warehouse & Logistics
• Effective Authentication Technologies
• Best selection of tamper-evident features
• Developing a RMP for your supply chain to protect your Brand, Product and Patient Safety
• Measuring the Effectiveness of a Good Quality System through frequent external and internal audits
• Debating the use and implementation of serialization, barcoding, and RFID
• Serialization Data and Analytics driven approach to increase supply chain agility
• Cloud-based technology complement big data solutions in monitoring and improving supply chain processes
• The need to understand and adopt new technologies like IoT, Analytics, Block chain, Machine Learning and Artificial Intelligence
• Case study: How companies are structuring their counterfeiting efforts and departments?

 

 

IQPC INSIGHTS: SUPPLY CHAIN EFFICIENCY AND NEW TECHNOLOGIES

The future of the pharma logistics sector will be characterised by solutions that are software driven rather than hardware driven. In this article, with insights from Amy Shortman, Founder and CEO of ASC Associates Ltd we will explore how the latest technologies will affect the sector, including:

• How new technologies will bridge communication between all parties and stakeholders in the supply chain

• What real time and predictive software systems mean for temperature excursion management

• How IoT and blockchain will shape a touchless, wireless, and secure logistics operation offering an ‘immutable level of traceability’ for products

Please click here for the full report 

ASC will be presenting this year at TCL 2018, we look forward to seeing you there.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Supply Chain Efficiencies & New Technologies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

January28th-31st2019

 

 

 

 

 

 

 

 

 

London,UnitedKingdom

Supply

ChainEfficiency

 

 

And

 

 

 

 

NewTechnologies

 

 

 

 

 

 

 

 

 

 

ExpertinsightfromAmyShortman

FounderandCEOofASCAssociatesLtd

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Supply

ChainEfficiency

 

AndNew

Technology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

AmyShortmanFounderandCEOofASCAssociatesLtd

RetroactiveLogistics:AThingofthePast…

 

 

 

 

 

 

 

 

 

IoTandblockchainwillenable

 

proactiveshipmentmanagement.Nolongerwillpractitionersberestrictedtopost-shipmentforanalysisandexcursionmanagement,increasingthesector’sabilitytomitigaterisktotheproductandthepatient.

 

 

 

 

 

 

Thefutureofthesectorwillbecharacterisedbysolutionsthataresoftwaredrivenrather

thanhardwaredriven.Thebenefitofthisisthatlogisticsservicesandshipperswillnolongerbetieddowntoasingledevice,orgroupofdevicesthathaverestrictedconnectivity.

 

 

 

 

 

 

Adevice-agnosticsoftwaresystemthat

 

canswitchtothelatesttechnology,whichwillputtheshipperinamuchmoreflexiblepositionintermsoftheirpurchasingability.Itwillalsoensurethatthesectorcanmaintainfluidityand

adapttonewertechnologiesfareasierthanever

 

before.

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pharma4.0,InternetofThings

 

 

 

 

 

 

Formanyyears,thetemperaturecontrolledlogisticssectorsufferedfromtechnologystagnation.Isthisstillthecase?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

“Clientscannowseewheretheirproductisinreal

time.”

Whatdoesinnovationlooklike?

Justonthehorizonisawidearrayofsoftwaresolutionsthatwillmarkashiftfromretrospectiveinterventiontoreal-time

intervention.

 

 

 

 

 

“Thebenefitofthesenewtechnologiesisthatit’sgoingtobereal-timeandpredictive.Whenexcursionsoccur,oraprocessdoesn’toccurasitshould,youhavetheopportunitytofixtheissueinreal-time,asopposedtoretrospectiveanalysis,”saysShortman.

 

 

 

 

 

 

 

“Abigpartofthesenewsolutionsishowthedataspeakstoallinvolvedparties.”Thedatacanbepulledfromdevicesandsenttoindividualsandorganisationswithinthesupplychaintoprevent

incidents.Thiscanbeanythingfromdamagereports,totheft,andtemperatureexcursions.

 

 

 

 

 

“Thesectorisnowatthestagewherewe’rebeginningtomoveawayfromhardwaresolutionsintosoftwaresolutions,”saysShortman.

 

 

 

 

Indeed,thelogisticssectordoesrunarisktopatientsifsoftwareissluggishinadaptingtomeettheindustry’schanges.However,Shortmanhighlightsthatinnovationisaroundthecorner.Therearenowproductscomprisedofindependentsoftwarethatcanconnecttoanydevicetype-andthiskindoftechnologyisavailableacrossthefullrangeoftransportsolutions.

 

 

 

 

Betterstakeholdercollaboration

“Thesectorhascomealongway,”Shortmansays.Whileitstillisn’tperfect,implementinganewtypeofsoftwaretransportationmanagementsystemissignificantlyfasterandmoreefficientthanitwasadecadeago.”Whatisavailableonthemarketnowisalmostlikeplugandplay,withAPIlinkstobringinrelevantdata,thistechnologyishugelybeneficialfromapush-pullpointofview.We’reseeingthatthesesolutionscanbesetupincrediblyquickly,andonceit’supandrunning,it’sallaboutensuringthattheworkflowscorrectly.”

 

 

 

 

Indeed,newtechnologieswillbridgecommunicationbetweenallpartiesandstakeholders.InaTCLscenario,apharmaceuticalcompanycansendatextmessagetoadriver,thedrivercandownloadanapp,andthentakephotographsofthesealofatemperaturereadoutwhilecollectingthe

shipment.Thisinformationcanbeuploadedinrealtimeandcanbesharedwitheveryoneonthesystem,accordingtoShortman.

 

 

 

 

“Ifanairlinewasusingsimilartechnologywecangivethematabletortheycanhaveatabletdevicewheretheycanalsouploadanyrelevantchecklists,againinrealtime,sothatwe’recapturingthataudittrailofwhat’shappening,whenit’shappening,whoit’shappeningby.”

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

January28th-31st2019

 

 

 

 

 

 

 

 

 

London,UnitedKingdom

Supply

ChainEfficiency

 

 

And

 

 

 

 

NewTechnologies

 

 

 

 

 

 

 

 

 

 

ExpertinsightfromAmyShortman

FounderandCEOofASCAssociatesLtd

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Supply

ChainEfficiency

 

AndNew

Technology

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

AmyShortmanFounderandCEOofASCAssociatesLtd

RetroactiveLogistics:AThingofthePast…

 

 

 

 

 

 

 

 

 

IoTandblockchainwillenable

 

proactiveshipmentmanagement.Nolongerwillpractitionersberestrictedtopost-shipmentforanalysisandexcursionmanagement,increasingthesector’sabilitytomitigaterisktotheproductandthepatient.

 

 

 

 

 

 

Thefutureofthesectorwillbecharacterisedbysolutionsthataresoftwaredrivenrather

thanhardwaredriven.Thebenefitofthisisthatlogisticsservicesandshipperswillnolongerbetieddowntoasingledevice,orgroupofdevicesthathaverestrictedconnectivity.

 

 

 

 

 

 

Adevice-agnosticsoftwaresystemthat

 

canswitchtothelatesttechnology,whichwillputtheshipperinamuchmoreflexiblepositionintermsoftheirpurchasingability.Itwillalsoensurethatthesectorcanmaintainfluidityand

adapttonewertechnologiesfareasierthanever

 

before.

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pharma4.0,InternetofThings

 

 

 

 

 

 

Formanyyears,thetemperaturecontrolledlogisticssectorsufferedfromtechnologystagnation.Isthisstillthecase?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

“Clientscannowseewheretheirproductisinreal

time.”

Whatdoesinnovationlooklike?

Justonthehorizonisawidearrayofsoftwaresolutionsthatwillmarkashiftfromretrospectiveinterventiontoreal-time

intervention.

 

 

 

 

 

“Thebenefitofthesenewtechnologiesisthatit’sgoingtobereal-timeandpredictive.Whenexcursionsoccur,oraprocessdoesn’toccurasitshould,youhavetheopportunitytofixtheissueinreal-time,asopposedtoretrospectiveanalysis,”saysShortman.

 

 

 

 

 

 

 

“Abigpartofthesenewsolutionsishowthedataspeakstoallinvolvedparties.”Thedatacanbepulledfromdevicesandsenttoindividualsandorganisationswithinthesupplychaintoprevent

incidents.Thiscanbeanythingfromdamagereports,totheft,andtemperatureexcursions.

 

 

 

 

 

“Thesectorisnowatthestagewherewe’rebeginningtomoveawayfromhardwaresolutionsintosoftwaresolutions,”saysShortman.

 

 

 

 

Indeed,thelogisticssectordoesrunarisktopatientsifsoftwareissluggishinadaptingtomeettheindustry’schanges.However,Shortmanhighlightsthatinnovationisaroundthecorner.Therearenowproductscomprisedofindependentsoftwarethatcanconnecttoanydevicetype-andthiskindoftechnologyisavailableacrossthefullrangeoftransportsolutions.

 

 

 

 

Betterstakeholdercollaboration

“Thesectorhascomealongway,”Shortmansays.Whileitstillisn’tperfect,implementinganewtypeofsoftwaretransportationmanagementsystemissignificantlyfasterandmoreefficientthanitwasadecadeago.”Whatisavailableonthemarketnowisalmostlikeplugandplay,withAPIlinkstobringinrelevantdata,thistechnologyishugelybeneficialfromapush-pullpointofview.We’reseeingthatthesesolutionscanbesetupincrediblyquickly,andonceit’supandrunning,it’sallaboutensuringthattheworkflowscorrectly.”

 

 

 

 

Indeed,newtechnologieswillbridgecommunicationbetweenallpartiesandstakeholders.InaTCLscenario,apharmaceuticalcompanycansendatextmessagetoadriver,thedrivercandownloadanapp,andthentakephotographsofthesealofatemperaturereadoutwhilecollectingthe

shipment.Thisinformationcanbeuploadedinrealtimeandcanbesharedwitheveryoneonthesystem,accordingtoShortman.

 

 

 

 

“Ifanairlinewasusingsimilartechnologywecangivethematabletortheycanhaveatabletdevicewheretheycanalsouploadanyrelevantchecklists,againinrealtime,sothatwe’recapturingthataudittrailofwhat’shappening,whenit’shappening,whoit’shappeningby.”

 

 

 

 

 

 

 

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