GIG - CEIV Pharma Certification 1. Work program. - Presentation - Rio de Janeiro, March 29, 2017

Transcription

1 CEIV Pharma Certification Work program - Presentation - Rio de Janeiro, GIG - CEIV Pharma Certification 1

2 Content Page 1.0 Introduction Project approach and methodology Project Organization, Team and Timelines Assessment agenda Project philosophy 71 GIG - CEIV Pharma Certification 2

3 Content 1.0 Introduction to CEIV Pharma 2.0 Project approach and methodology 3.0 Project organization, timeline, and potential team 4.0 Assessment agenda 5.0 Project philosophy GIG - CEIV Pharma Certification 3

4 Air Cargo Industry Concerns and Challenges The pharmaceutical industry has relied heavily on the airline industry for its speed and efficiency but air cargo s share of global pharmaceutical products transport has dropped Pharma air cargo growth; in % HOWEVER Air cargo s share of global pharmaceutical products transport (in %) Over the past 10 years, air carriers, handlers and freight forwarders have responded with branded products and services to grab a share of this lucrative and niche market Source: Pharmaceutical Commerce GIG - CEIV Pharma Certification 4

5 Background: Critical Issues Raised by the Shippers The use of air-mode transportation is re-considered unless industry partners ensure quality services 25% 30% 20% Of vaccines reach their destination degraded because of incorrect shipping Of scrapped pharmaceuticals can be attributed to logistics issues alone Of temperature-sensitive products are damaged during transport due to a broken cold chain Due to a lack of compliance, standardization, accountability and transparency across the air transport supply chain a majority of all temperature excursions occur while the package is in the hands of airlines/airports Temperature deviation denature the product, render it worthless and be harmful to the health of the patient Products can be lost, scrapped, returned leading to significant costs GIG - CEIV Pharma Certification 5

6 Background: Critical Issues Raised by the Shippers Looses associated with temperature excursions in healthcare are around a staggering ~USD 35B Losses associated with temperature excursions In USD Billion Total: USD 34.1B The average costs of root cause analysis for each excursion can range from $3K to up to $10K (avg. USD 6.5K per year) Wasted Logistic Costs Clinical Trial Costs 8.60 Trial Production Costs Direct Labor Costs Opportunity Labor Costs Replacement Costs Root Cause Analysis Source: World Health Organization, Parenteral Drug Association, worldpharmaceuticals.net, cargosense.com, other industrial analysis GIG - CEIV Pharma Certification 6

7 Objectives of CEIV Pharma To ensure the integrity of the product is maintained throughout the supply chain OBJECTIVES Prevent sanitary issues caused by temperature excursions during transportation. Ensure product integrity Improve handling of pharmaceutical products and compliance with existing regulations + standards. Elevate level staff competency through efficient and robust training program. Create a global and consistent certification that industry can rely on. GIG - CEIV Pharma Certification 14

8 CEIV Pharma Targets Who does CEIV Pharma target? The supply chain Trucking Companies Freight Forwarders Distributors Ground Handlers Airlines Airports GIG - CEIV Pharma Certification 15

9 CEIV Pharma Standard Focus is on global coverage and universality IATA GUIDELINES GOOD DISTRIBUTION PRACTICES LOCAL + REGIONAL GUIDELINES + + E.g. Singapore GDP & GDPMDS or FAGG in Belgium = = CEIV Pharma: encompasses various regulations and standards e.g. EU GDP. covers GDP requirements. aims at covering international standards and country-specific requirements. aims at reducing the number of audits or simplifying them. aims to align air cargo stakeholders needs. GIG - CEIV Pharma Certification 16

10 CEIV Pharma Standard Review, compare against best practice, establish findings, offer recommendations for change, identify and mitigate risks, develop implementation plan Assessment Criteria applied Quality management Personnel Training Documentation Infrastructure + equipment Operations Complaints, returns and counterfeit Supplier management Self-inspections Transportation Specific provisions for brokers Issues tackled Content of manuals and guidelines Procedures for Audits Procedures for describing packaging systems Acceptance checklist quality and operating agreements Packaging requirements Documentation & labeling Acceptance & control Facilities and equipment Staff training requirements Training adequacy and currency GIG - CEIV Pharma Certification 17

11 Visibility for CEIV Pharma validated entities Validated entities are visible on IATA s website GIG - CEIV Pharma Certification 20

12 CEIV Pharma Entities Certified World GIG - CEIV Pharma Certification 21

13 CEIV Pharma Entities Certified North America Locations Certification Completed Certification in Progress Boston Chicago Columbus Dallas Indianapolis Kansas City Lester Los Angeles Miami New York Saint Louis San Diego San Francisco Tampa GIG - CEIV Pharma Certification 22

14 CEIV Pharma Entities Certified LATAM Locations 7 2 Certification Completed Certification in Progress GIG - CEIV Pharma Certification 23

15 CEIV Pharma Certification in progress World GIG - CEIV Pharma Certification 24

16 CEIV Pharma (Community Approach) Community Approach Development Worldwide GIG - CEIV Pharma Certification 25

17 CEIV Pharma (Community Approach) Community Approach Development Europe GIG - CEIV Pharma Certification 26

18 CEIV Pharma (Community Approach) Community Approach Development Europe GIG - CEIV Pharma Certification 27

19 CEIV Pharma (Community Approach) Community Approach Development Europe GIG - CEIV Pharma Certification 28

20 CEIV Pharma (Community Approach) Community Approach Development Europe GIG - CEIV Pharma Certification 29

21 CEIV Pharma (Community Approach) Community Approach Development Asia GIG - CEIV Pharma Certification 30

22 CEIV Pharma (Community Approach) Covering the supply chain Pharma shippers Example (BRUCargo) Forwarders with pharma focus Handlers Truckers Facilitators Airlines Regulators TTTF GIG - CEIV Pharma Certification 31

23 CEIV Pharma (Coverage) Covering the supply chain Example (AMS) Forwarders with pharma focus Truckers Handlers Airlines GIG - CEIV Pharma Certification 32

24 CEIV Pharma (Coverage) Covering the supply chain Example (FRA) Forwarders with pharma focus Truckers Handlers Airlines GIG - CEIV Pharma Certification 33

25 CEIV Pharma (Coverage) Covering the supply chain Example (BSL) Forwarders with pharma focus Truckers Handlers Airlines GIG - CEIV Pharma Certification 34

26 Content 1.0 Introduction 2.0 Project approach and methodology 3.0 Project organization, timeline, and potential team 4.0 Assessment agenda 5.0 Project philosophy GIG - CEIV Pharma Certification 35

27 Project Approach and Methodology IATA will certify companies in several steps 1 Preparation 2 Assessment 3 Validation Assemble team; Prepare project logistics; Send data and information request; Send interview request sheet for first visit. 2 weeks before assessment. On-site assessment by Independent validator Assessment versus minimum IATA Temperature Controlled Audit Checklist ; Comparison against best practice; Establish findings and offer recommendations for change; On-site visit by an Independent Validator to review progress made against recommendations during the assessment phase. Drafting of report. Min 6-8 weeks after the assessment. 5 Certification Develop implementation plan and secure resources. Drafting of report. Training required for certification Additional Training GIG - CEIV Pharma Certification 36

28 Training required for certification The diploma includes 4 pharmaceutical specialized courses. Upon successful completion of the 4 courses, the participants will obtain an IATA Diploma. Training required for certification Temperature Controlled Cargo Operations Risk, Audit and Quality of Temperature Controlled Cargo Successful completion of: 2 key personal on the audit training (5 days); 2 key personal distance learning handling training; and 2 competent personal on the handling training (3 days). GIG - CEIV Pharma Certification 40

29 Additional Training Introduction to Time and Temperature Pharmaceutical Products Additional Training 4-6 hours training. Key topics: Pharmaceutical products Processes & procedures related to job functions Identification and labelling Effect of temperature on pharmaceutical products Avoidance of counterfeits Passive and active packing Product security All personnel involved in handling pharmaceutical products activities per station should be trained on IATA Introduction to Time and Temperature Pharmaceutical Products course (or equivalent)) within period of 12 months after the Certification GIG - CEIV Pharma Certification 43

30 Deliverables Step 1: Assessment Step 2: Validation CEIV Pharma criteria catalogue (checklist). Report covering the findings and recommendations based on the assessment;. Implementation plan. Report and implementation plan will set out assumptions, findings, results, conclusions and recommendations and will specifically: Identify critical elements that are not compliant with national and international Regulations and the defined CEIV Pharma Handling criteria (e.g. TCR); Outline the impact of non-compliance; and Identify elements that are inefficient. Progress report to review the progress made against recommendations during the assessment phase. Implementation plan update. Recommendation to award certification of Premium Pharmaceutical Handling Centers based on satisfactory compliance of CEIV criteria. Presentation of the validation findings to Senior Management. Presentation to Senior Management.. GIG - CEIV Pharma Certification 47

31 Content 1.0 Introduction: Review Phase Project approach and methodology: Phase Project organization, timeline, and potential team 4.0 Assessment agenda 5.0 Project philosophy GIG - CEIV Pharma Certification 50

32 Project Participants GIG - CEIV Pharma Certification 51

33 Project Organization The project will be conducted with close cooperation between GIG, the community and IATA Structure Roles and responsibilities Expert Support Project Management Project Teams Project Management Work Streams Expert Support Assume responsibility for project s progress and results Align activities and progress across work streams Align progress and direction with Steering Committee Steer change management Perform day-to-day project work in close interaction with GIG Run quantitative and qualitative analyses Conduct interviews, prepare presentations, etc. Apply change management tools in alignment with Project Lead and respective Experts Provide key insights and advice on specific topics Support interviews Support with specialized calculations and analyses GIG - CEIV Pharma Certification 52

34 Project Organization Alexis SIORIS and Ronald SCHAEFER from IATA will lead the project jointly Project Management Standards Pharma Forum GIG TBD IATA Ronald SCHAEFER Andrea Gruber Pharma shippers Customs Training Yaniv Sorany Company 1 Company 2 Company 3 TBD TBD TBD Company 4 Company 5 Company 6 TBD TBD TBD GIG - CEIV Pharma Certification 53

35 Project Organization Tasks of all team members Development problem catalogue Development of initiatives (bottom-up) Derive quick wins Conduct interviews & meetings Moderate workshops Desk research & provide information Reporting to project management GIG - CEIV Pharma Certification 54

36 Project Organization Team member tasks will be divided between IATA and GIG according to the defined scope of work Team set up / task description / team members No. Team Content/Tasks IATA Project Teams GIG 2. Project Management 1. Project Management Design of project organization Approval of significant measures Monitoring and control of implementation Approve employees for project teams Select companies / employees for teams Define targets Conduct project communication Project administration Coordination with Pharma Forum Mr. Ronald SCHAEFER TBD GIG - CEIV Pharma Certification 55

37 Project Organization Each company will need to name a Project Coordinator with whom IATA can liaise directly Team set up / task description / team members No. Team Content/Tasks IATA Project Teams GIG 3. Project teams 1. Assessment Assessment versus CEIV Pharma standard; Compare against best practice; Establish findings; Offer recommendations for change; Develop implementation plan and secure resources. TBD TBD 2. Validation Progress report to review the progress made against recommendations during the assessment phase. Implementation plan update. Presentation to Senior Management; and Award Certificate CEIV Pharma Certified GIG - CEIV Pharma Certification 56

38 Project Organization Each company will need to name a Training Coordinator with whom IATA can liaise directly Team set up / task description / team members No. Team Content/Tasks IATA Project Teams GIG 3. Project teams 3. Training Develop and manage the training program content Manage training instructors Monitor product performance Manage all the training administrative aspects, logistics and timeline Ms. Yaniv SORANY TBD IATA Pharmaceutical Trainings TCC Operation Training TCC Audit, Quality + Risk Management GIG - CEIV Pharma Certification 57

39 Reporting Reports will be thorough, address the different stakeholders and delivered on-time Project Reporting Ref. Reports Content Recipients Timeframe / Length R01 Work plan (Kick-off) Activities and associated methodologies Identify all key dates and milestones for the Project timetable. Project Management. Team members DD/MMM/2017 R02 CEIV Pharma checklist CEIV Pharma criteria Project Management. Team members 4 weeks before assessment 4 weeks before assessment R03 Assessment report for entity Findings Recommendations Project Management. Team members Draft: 2 weeks after assessment Final: 4 weeks after assessment R04 Validation report Findings Recommendations Project Management. Team members Draft: 2 weeks after validation Final: 4 weeks after validation GIG - CEIV Pharma Certification 58

40 Reporting Reports will be thorough, address the different stakeholders and delivered on-time Project Reporting Ref. Reports Content Recipients R05 Monthly Progress Report Actions & achievements. Problems encountered. Highlight activities planned. Project Management. Timeframe / Length Once a month or when requested. R06 MS Project Plan Project timetable. Project Management. Bi-monthly or after major change request. R07 Minutes of Meeting Main action items. All 3 business days after meeting. GIG - CEIV Pharma Certification 59

41 Meeting routine We have developed a meeting routine to allow for a sound and effective coordination of the project Project Meetings Ref. Meeting & Purpose Participants Timeframe / Length M01 Project Management meeting: Internal meeting to discuss progress (jour fixe) TBD Mr. Ronald SCHAEFER At the beginning and end of the project or when requested (120 min.). M02 Teams GIG project team Participating companies IATA project team Monthly / (30 min.) In person or via phone call. M03 Kick-off GIG project team Participating companies IATA project team 16/FEB/2017 M04 Ad-hoc workshops / meetings Project management / project teams. When required or requested. GIG - CEIV Pharma Certification 60

42 Trainings Project Milestones Steps Date(s) 1 On-site Project Kick-off DD/MAR/ Trainings JUN-JUL/ Start of on-site Assessment Assessment reports AUG/2017 SEP/ Start of validation (first station) (tentative) Certification (first station) (tentative) OCT/2017 NOV/2017 GIG - CEIV Pharma Certification 61

43 Timeline 2017 Dates 2017 Activities April May June July August September October November A. Project management Preparation PM meeting B. Training (1 st group) TCC operations Risk, auditing & quality C. Assessment On-site Reports D. Validation After completion of assessment and training Milestone GIG - CEIV Pharma Certification 62

44 Timeline 2017 Immediate next steps starting now Procedure / Milestones Timeframe Responsible Mobilization / Contract signature IATA / GIG Preparation training facilities GIG Kick-off Training: TCC Cargo Operations Training Training: Audit, Quality and Risk Management 25/MAY/2016 IATA IATA IATA Validation: Send Checklist Validation: Send Assessment agenda Validation: Start conducting assessments 18/JAN/ /JAN/2016 IATA IATA IATA / CEIV Pharma Candidate EuroAirport - CEIV Pharma Certification 63 December 11, 2015

45 Training Dates Trainings planned Start Date End 9Date Duration DD/MMM/YY DD/MMM/YY 3 DD/MMM/YY DD/MMM/YY 5 Training Name Temperature-Controlled Cargo Operations (Classroom, 3 days) - Classroom English Audit, Quality and Risk Management for Temperature Controlled Cargo (Classroom, 5 Days) - Classroom English Venue / Location Rio de Janeiro, Brazil Rio de Janeiro, Brazil Instructor TBD TBD GIG - CEIV Pharma Certification 64

46 Assessment dates Assessments planned Start Date End Date Duration Validation stage Company Independent Validator DD-MMM-YY DD-MMM-YY 2 Assessment on-site Company TBD DD-MMM-YY DD-MMM-YY 2 Assessment on-site Company TBD DD-MMM-YY DD-MMM-YY 2 Assessment on-site Company TBD DD-MMM-YY DD-MMM-YY 2 Assessment on-site Company TBD DD-MMM-YY DD-MMM-YY 2 Assessment on-site Company TBD DD-MMM-YY DD-MMM-YY 2 Assessment on-site Company TBD GIG - CEIV Pharma Certification 65

47 CEIV Pharma Certification Timeline Summary of Assessment Reporting Process Step 1 Step 3 Step 5 Step 7 Step 9 Assessment is conducted onsite (2 days) Independent Validator submits assessment report Draft assessment report is submitted to Company Quality review is conducted by expert If applicable, IV conducts reevaluation and makes changes to assessment report Day 1 Day 3-9 Day 10 Day Day 15 Day 15 Day Day 20 Day Day 25 >>> Step 2 Step 4 Step 6 Step 8 Step 10 Independent Validator finalizes development of draft assessment report IATA edits the assessment report Simultaneousl y the assessment report is submitted to quality review expert If applicable, assessment report with comments is submitted to IV for reevaluation If applicable, revised report is submitted to Company Source: IATA GIG - CEIV Pharma Certification 66

48 Content 1.0 Introduction 2.0 Project approach and methodology 3.0 Project Organization, Team and Timelines 4.0 Assessment agenda 5.0 Project philosophy GIG - CEIV Pharma Certification 67

49 Assessment preparation : Please make sure follow documents are available in the room : Signed contracts with subcontractors Summary of all outsourced activities Last 2 internal self-inspection reports Last 2 audit reports and actions Process flow of the operations Organigram of the management structure in the company Access cards to all relevant area s. GIG - CEIV Pharma Certification 68

50 Assessment Agenda Day 1 08:00 Arrival & introduction 08:30 Presentation company 09:00 Premises and process flow (in the warehouse) 11:00 Quality Management system 12:00 Break 13:00 Personnel and training records related to GDP. 14:30 Documentation 15:30 Outsourced activities 16:30 End of day assessment and create findings 17:00 Closure meeting and review agenda day 2 17:30 End of day 1 GIG - CEIV Pharma Certification 69

51 Assessment Agenda Day 2 08:00 Arrival 08:30 Transportation 10:30 Follow up on findings day 1 12:00 Break 13:00 Continue findings day 1 & 2 15:30 end of day assessment and create findings 16:00 Closure meeting + follow up next steps 17:30 End of assessment GIG - CEIV Pharma Certification 70

52 Content 1.0 Introduction 2.0 Project approach and methodology 3.0 Project organization, timeline, and potential team 4.0 Assessment agenda 5.0 Project philosophy GIG - CEIV Pharma Certification 71

53 Project philosophy A successful project is based on four crucial drivers Approach for quick actions and project management 1 Change management philosophy (Organizational Structure, Communication, Leadership and Education) Project organization and Structuring of tasks and Follow-up of projects core team implementation of Status report Members and projects Review their tasks Tasks/ project meetings Detailed and structured GIG - CEIV Pharma Certification 72

54 Project philosophy Active involvement and openness are key for a successful process 1 Change management philosophy stakeholder approach Open-minded and dedicated management Emphasize change management as process controller Initiate changes - time as parameter for management in addition to costs Embrace changes/ideas open-mindedly Specialized and motivated teams Open communication about pending changes in the company Make those affected feel like participants Project cooperation without ranks or titles Joint workshops on a regular basis High degree of identification with process Reorientation and cultural revolution Fundamental reorientation through change of strategies, structures and implementation of controlling systems Cultural revolution means: abolition to overcome traditions presentation of new visions tight management while showing opportunities and reduction of frustrations through motivation Open communication and encourage participation Open communication about pending changes in the company Make those affected feel like participants Assurance of self-motivated change from the inside GIG - CEIV Pharma Certification 73

55 Project philosophy Seeking a balanced relationship with employees, customers and shareholders contributes to the success of our clients 1 Change management philosophy stakeholder approach Customers Safety and security Reliability Attractive network Brand/identity Employees Job security Career opportunities Attractive working conditions Shareholders Economic value added Risk profile Earnings per share Preparation for the future Other motivation drivers GIG - CEIV Pharma Certification 74

56 Project philosophy Our methodology, developed and refined through our work in similar assignments, leverages a unique wealth of experience and knowledge 2 Project organization Planning Development of a comprehensive work plan that addresses how the elements will be accomplished within the allotted cost and schedule Assessment Series of project assessments throughout the project Goal is to identify all information required to execute the project Execution The Project Manager and Team Leaders will apply their expertise to control risks, streamline development processes, and provide product quality Quality Assurance Quality System based on the ISO 9001:2000 platform. The Quality System: Defines the responsibility levels of each of the team members; Outlines the specific deliverables required for each team member and each procedure; Specifies time frames and delivery dates for deliverables; GIG - CEIV Pharma Certification 75 Quality Assurance Quality System based on the ISO 9001:2000 platform. The Quality System: Specifies documentation requirements Provides standard document forms to be used throughout the project; and Specifies how documentation will be used, recorded, distributed and filed Implementation of the Quality System ensures the quality of the work to be provided by all project members

57 Project philosophy The project organization works across the line organization and is managed by the Steering Committee 2 Project organization Integration of project organization into the line Project controlling Steering Committee Board B1 Advantage: Avoidance of friction losses and control problems Project Manager Project Team Taskforce Clear communication and responsibilities Definite roles and tasks of project organization = Technical coordination/functional contact person BN= Section (e.g., finance) - = Reporting GIG - CEIV Pharma Certification 76

58 Project philosophy Quick actions and project activities will be anchored in action plans and implemented by project teams (if applicable) 3 Structuring of tasks Action packages Schedule Topics 1. Flight Ops 2. Network Mgt.... Tasks Cooperation XYZ Solution Low-End-CK Solution ABC/DEF Solution BBY RRZ Value analysis Impl. Solution New development Implementation Serie Implementation management Actions Personnel Quantitative Qualitative 3. IT Neustrukturierung Fertigung und Montage Umsetzung Project Plan: (Standort XY) Responsible: Mr. Müller Status: Realisierung Description: 1998/ / / / /03 Revenue impact Result impact Goal(quantitative): Gross-CF-impact Risks: Counter effects: Planning of single steps Single steps Jan Feb Mar Apr. May Jun Jul... Result Status Responsible Step a) Mr. XXX Step b) Mrs. Hansen Step c) Mr. Webber Step d) Mrs. Julius Implementation Projects running Internal project teams Teams supported by IATA Project management GIG - CEIV Pharma Certification 77

59 Project philosophy Continuous planning, controlling and reviewing of project progress 4 Follow-up and review A project management plan Project schedule management Quality assurance practices Elements of our project management approach Project cost controls GIG - CEIV Pharma Certification 78

60 Thank you! For further information, contact: Ronald SCHAEFER Assistant Director, Cargo / Ground Operations and CEIV Consulting Miami, FL SchaeferR@iata.org Tel: Mob: GIG - CEIV Pharma Certification 79