ceiv pharma certification - riogaleaocargo.com§ão-ronald-schaefer-iata.pdfthe pharmaceutical...

March 29, 2017GIG - CEIV Pharma Certification 1

CEIV Pharma Certification

Work program

- Presentation -

Rio de Janeiro, March 29, 2017


Content Page

1.0 Introduction 3

2.0 Project approach and methodology 35

3.0 Project Organization, Team and Timelines 50

4.0 Assessment agenda 68

5.0 Project philosophy 71

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



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

Source: Pharmaceutical Commerce

HOWEVER

17

11

2000 2013

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.

Pharma air cargo growth; 2008-2018in %

6

12

2008-2013 2013-2018


Background: Critical Issues Raised by the Shippers

The use of air-mode transportation is re-considered unless industry partners ensure

quality services

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

25%Of vaccines reach their destination

degraded because of incorrect

shipping

30%Of scrapped pharmaceuticals can

be attributed to logistics issues

alone

20%Of temperature-sensitive products

are damaged during transport due

to a broken cold chain


Background: Critical Issues Raised by the Shippers

Looses associated with temperature excursions in healthcare are around a staggering

~USD 35B

1.00

3.65

5.65

8.60

15.20

Wasted Logistic Costs Replacement Costs

Clinical Trial Costs Root Cause Analysis

1.3

2

2.34

Trial Production Costs

Direct Labor Costs

Opportunity Labor Costs

Source: World Health Organization, Parenteral Drug Association, worldpharmaceuticals.net, cargosense.com, other industrial analysis

The average costs of root

cause analysis for each

excursion can range from $3K

to up to $10K (avg. USD 6.5K

per year)

Losses associated with temperature excursionsIn USD Billion

Total: USD 34.1B


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.

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.

Ensure product

integrity


CEIV Pharma Targets

Who does CEIV Pharma target? The supply chain

Trucking

CompaniesFreight

ForwardersDistributors

Ground

HandlersAirlines Airports


CEIV Pharma Standard

Focus is on global coverage and universality

IATA GUIDELINES GOOD DISTRIBUTION

PRACTICES

E.g. Singapore

GDP & GDPMDS

or FAGG in

Belgium

LOCAL + REGIONAL

GUIDELINES

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.

+ +

= =


CEIV Pharma Standard

Review, compare against best practice, establish findings, offer recommendations for

change, identify and mitigate risks, develop implementation plan

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

Assessment

Criteria applied

Quality management

Personnel

Training

Documentation

Infrastructure + equipment

Operations

Complaints, returns and counterfeit

Supplier management

Self-inspections

Transportation

Specific provisions for brokers


Visibility for CEIV Pharma validated entities

Validated entities are visible on IATA’s website


CEIV Pharma – Entities Certified

World



North America

13 Certification in Progress

Certification Completed

Locations

20

Boston

Chicago

Columbus

Dallas

Indianapolis

Kansas City

Lester

Los Angeles

Miami

New York

Saint Louis

San Diego

San

Francisco

Tampa



LATAM

2 Certification in Progress

Certification Completed

Locations

7


CEIV Pharma – Certification in progress

World


CEIV Pharma (Community Approach)

Community Approach Development Worldwide



Community Approach Development Europe



Community Approach Development Asia



Covering the supply chain

Pharma shippers

Forwarders with pharma focus

Handlers

Truckers

Airlines

TTTF

Regulators

Facilitators

Example (BRUCargo)

http://www.honeywell.com/

http://www.honeywell.com/

http://www.thecoca-colacompany.com/index.html

http://www.thecoca-colacompany.com/index.html

http://www.tessenderlo.com/

http://www.tessenderlo.com/

http://www.franchiseformules.be/data/afbeeldingen/logo-delhaize.jpg

http://www.franchiseformules.be/data/afbeeldingen/logo-delhaize.jpg

http://www.dredging.com/

http://www.dredging.com/

http://www.besix.com/homeFR

http://www.besix.com/homeFR

http://www.eyes-e-tools.com/customer/nitto/tree/treeframe.asp

http://www.eyes-e-tools.com/customer/nitto/tree/treeframe.asp

http://www.awdc.be/

http://www.awdc.be/

http://beanrd201.corp.go2uti.com/Intranet/bru_main.htm

http://beanrd201.corp.go2uti.com/Intranet/bru_main.htm


CEIV Pharma (Coverage)



Truckers

Handlers

Airlines

Example (AMS)





Truckers

Handlers

Airlines

Example (FRA)





Truckers

Handlers

Airlines

Example (BSL)

Content

1.0 Introduction







Project Approach and Methodology

IATA will certify companies in several steps

Preparation1

Assessment 2

Validation3

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;

Develop implementation plan

and secure resources.

Drafting of report.

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

Training required for certificationAdditional

Training


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

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).

Temperature

Controlled

Cargo Operations

Risk, Audit and Quality of

Temperature Controlled

Cargo


Additional Training

Introduction to Time and Temperature Pharmaceutical Products

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”

Additional Training


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.

Presentation to Senior Management..

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.

Content

1.0 Introduction: Review Phase 1

2.0 Project approach and methodology: Phase 2






Project Participants


Project Organization

The project will be conducted with close cooperation between GIG, the community and

IATA

Project Management

Project

Teams

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

Work Streams 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

Expert Support Provide key insights and advice on specific topics Support interviews Support with specialized calculations and analyses

Project Management

Roles and responsibilitiesStructure



Alexis SIORIS and Ronald SCHAEFER from IATA will lead the project jointly

Company 3Company 1

TBD TBD

Project Management

GIG TBD

IATA Ronald

SCHAEFERPharma Forum

Pharma shippers Customs

Company 2

TBD

Company 6Company 4

TBD TBD

Company 5

TBD

Standards

Andrea Gruber

Training

Yaniv Sorany



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



Team member tasks will be divided between IATA and GIG according to the defined

scope of work

Team Content/TasksNo.

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

1.

Project Teams

TBD

GIGIATA

Mr. Ronald SCHAEFER

2. Project Management

Team set up / task description / team members



Each company will need to name a Project Coordinator with whom IATA can liaise

directly


1.

2.

Project Teams

Assessment

Validation

Assessment versus CEIV Pharma

standard;

Compare against best practice;

Establish findings;

Offer recommendations for change;

Develop implementation plan and

secure resources.

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”

3. Project teams

TBDTBD


GIGIATA



Each company will need to name a Training Coordinator with whom IATA can liaise

directly


3.

Project Teams

Training Develop and manage the training

program content

Manage training instructors

Monitor product performance

Manage all the training

administrative aspects, logistics and

timeline

IATA Pharmaceutical Trainings

TCC Operation Training

TCC Audit, Quality + Risk

Management

3. Project teams

Ms. Yaniv SORANY


GIGIATA

TBD


Reporting

Reports will be thorough, address the different stakeholders and delivered on-time

Project Reporting

Timeframe / LengthReportsRef. Content Recipients

Work plan

(Kick-off)

CEIV Pharma

checklist

Assessment

report for

entity

Validation

report

Project Management.

Team members

Project Management.

Team members

Project Management.

Team members

Project Management.

Team members

Activities and associated

methodologies

Identify all key dates and

milestones for the

Project timetable.

CEIV Pharma criteria

Findings

Recommendations

Findings

Recommendations

R01

R02

R03

R04

DD/MMM/2017

4 weeks before

assessment

4 weeks before

assessment

Draft: 2 weeks

after assessment

Final: 4 weeks

after assessment

Draft: 2 weeks

after validation

Final: 4 weeks

after validation


Reporting

Reports will be thorough, address the different stakeholders and delivered on-time

Project Reporting

Timeframe / LengthReportsRef. Content Recipients

Project Management.

Project Management.

All

Actions & achievements.

Problems encountered.

Highlight activities planned.

Project timetable.

Main action items.

R05

R06

R07

Once a month or

when requested.

Bi-monthly or after

major change

request.

3 business days

after meeting.

Monthly

Progress

Report

MS Project

Plan

Minutes of

Meeting


Meeting routine

We have developed a meeting routine to allow for a sound and effective coordination of

the project

Participants Timeframe / LengthMeeting & PurposeRef.

M01

M02

M03

M04

Project Management

meeting: Internal

meeting to discuss

progress (jour fixe)

Teams

Kick-off

Ad-hoc workshops /

meetings

TBD

Mr. Ronald SCHAEFER

GIG project team

Participating companies

IATA project team

GIG project team

Participating companies

IATA project team

Project management / project teams.

At the beginning and end

of the project or when

requested (120 min.).

Monthly / (30 min.) – In

person or via phone call.

16/FEB/2017

When required or

requested.

Project Meetings


Project Milestones

Trainings

Steps Date(s)

1

2

On-site Project Kick-off DD/MAR/2017

Trainings

JUN-JUL/2017

4

Start of validation (first station) (tentative)

Certification (first station) (tentative)

OCT/2017

NOV/2017

3

Start of on-site Assessment

Assessment reports

AUG/2017

SEP/2017


Timeline 2017

Milestone

Activities

Dates

April May

A. Project

management

Preparation

PM meeting

B. Training (1st

group)

TCC operations

Risk, auditing &

quality

C. Assessment

On-site

Reports

D. Validation

2017

After completion of

assessment and

training

June July August September October November

December 11, 2015EuroAirport - CEIV Pharma Certification 63

Timeline 2017

Immediate next steps starting now

ResponsibleTime-

frame

Procedure /

Milestones

Mobilization / Contract signature

Preparation training facilities

Kick-off

Training: TCC Cargo Operations

Training

Training: Audit, Quality and Risk

Management

Validation: Send Checklist

Validation: Send Assessment

agenda

Validation: Start conducting

assessments

IATA / GIG

GIG

IATA

IATA

IATA

IATA

IATA

IATA / CEIV Pharma

Candidate

17.04.-

21.04

01.05.-

05.05

15.05.-

19.05

10.04.-

14.04

18/JAN/2016

25/MAY/2016

24.04.-

28.04

08.05.-

12.05

22.05.-

26.05

18/JAN/2016


Training Dates

Trainings planned

StartDate

End9Date

Duration Training NameVenue /

LocationInstructor

DD/MMM/YY DD/MMM/YY 3

Temperature-Controlled Cargo

Operations (Classroom, 3

days) - Classroom – English

Rio de Janeiro,

BrazilTBD

DD/MMM/YY DD/MMM/YY 5

Audit, Quality and Risk

Management for Temperature

Controlled Cargo (Classroom,

5 Days) - Classroom – English

Rio de Janeiro,

BrazilTBD


Assessment dates

Assessments planned

StartDate

EndDate

Duration Validation stage CompanyIndependentValidator

DD-MMM-YY DD-MMM-YY 2 Assessment – on-site Company TBD






CEIV Pharma Certification Timeline


Summary of Assessment Reporting Process

Source: IATA

Day

1

Day

3-9

Day 10

Day

11-14

Day

15

Day

15

Day

16-19

Day

20

Day 21-24

Day

25

Step 2

Independent Validator finalizes development of draft assessment report

Step 4

IATA edits the assessment report

Step 6

Simultaneously the assessment report is submitted to quality review expert

Step 8

If applicable, assessment report with comments is submitted to IV for reevaluation

Step 1

Assessment is conducted onsite (2 days)

Step 3

Independent Validator submits assessment report

Step 5

Draft assessment report is submitted to Company

Step 7

Quality review is conducted by expert

Step 9

If applicable, IV conducts reevaluation and makes changes to assessment report

Step 10

If applicable, revised report is submitted to Company

>>>


Content

1.0 Introduction


3.0 Project Organization, Team and Timelines




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.


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


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

Content

1.0 Introduction







Project philosophy

A successful project is based on four crucial drivers

Project

organization and

core team

Members and

their tasks

Approach

for quick actions and project management

Structuring of

tasks and

implementation of

projects

Tasks/ project

Detailed and

structured

Follow-up of

projects

Status report

Review

meetings

Change management philosophy(Organizational Structure, Communication, Leadership and Education)

1

2 3 4


Project philosophy

Active involvement and openness are key for a successful process

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

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

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

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

Change management philosophy – stakeholder approach1


Project philosophy

Seeking a balanced relationship with employees, customers and shareholders

contributes to the success of our clients

Shareholders

Safety and security

Reliability

Attractive network

Brand/identity

Economic value added

Risk profile

Earnings per share

Preparation for the future

Other motivation drivers

Job security

Career opportunities

Attractive working

conditions

Employees

Customers

Change management philosophy – stakeholder approach1


Project philosophy

Our methodology, developed and refined through our work in similar assignments,

leverages a unique wealth of experience and knowledge

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;

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

ExecutionThe Project Manager and

Team Leaders will apply their expertise to control risks, streamline development processes, and provide product quality

PlanningDevelopment of a

comprehensive work plan that addresses how the elements will be accomplished within the allotted cost and schedule

AssessmentSeries of project

assessments throughout the project

Goal is to identify all information required to execute the project

Project organization2


Project philosophy

The project organization works across the line organization and is managed by the

Steering Committee

Integration of project organization into the line

= Technical coordination/functional contact person BN= Section (e.g., finance) - = Reporting

Advantage:

Avoidance of friction

losses

and control problems

Clear communication and

responsibilities

Definite roles and tasks of

project organization

Project controlling

Project Manager

B1

Taskforce

Project Team

Steering Committee Board

Project organization2


Project philosophy

Quick actions and project activities will be anchored in action plans and implemented by

project teams (if applicable)

Implementation

management

Tasks

Cooperation XYZ

Topics

1. Flight Ops

2. Network Mgt. ...

3. IT

Solution Low-End-CK

Solution ABC/DEF

Solution BBY RRZ

Value analysis Impl.

Solution

New development Implementation Serie

Neustrukturierung Fertigung und Montage

(Standort XY)

Umsetzung

Realisierung

Revenue impact

Result impact

Gross-CF-impact

1998/99 1999/00 2000/01 2001/02 2002/03

Project Plan: Responsible: Mr. Müller Status: 10.08.

Risks: Counter effects:

Description:

Goal(quantitative):

Planning of single steps

Status ResponsibleResultJan Feb Mar Apr. May Jun Jul ...

Mr. XXX

Mrs. Hansen

Mr. Webber

Mrs. Julius

–

–

Single steps

Step a)

Step b)

Step c)

Step d)

Action

packages

Schedule

Actions

Personnel

Quantitative

Qualitative

Projects

running

Internal project

teams

Teams

supported by

IATA

Project management

Implemen-

tation

Structuring of tasks3


Project philosophy

Continuous planning, controlling and reviewing of project progress

Elements of our project

management approach

A project management plan Project schedule management

Quality assurance

practices

Project cost controls

Follow-up and review4

Thank you!

For further information, contact:

Ronald SCHAEFER

Assistant Director, Cargo / Ground

Operations and CEIV Consulting

Miami, FL

Email: [email protected]

Tel: + 1 305 779 9873

Mob: + 1 305 586 4666

March 29, 201779GIG - CEIV Pharma Certification

mailto:[email protected]

ceiv pharma certification - riogaleaocargo.com§ão-ronald-schaefer-iata.pdfthe pharmaceutical...

Documents