1. Art and Diseño

AGENDA
CERTIFICATE COURSE IN ENSURING PRODUCT QUALITY IN PROCUREMENT AND SUPPLY CHAIN MANAGEMENT
09 – 14 MARCH, 2015; BANGKOK (THAILAND)
TOPICS DAY WISE
DAY & DATE
TIMINGS
09:30-11:30
11:45-13:00
13:00-13:45
Introduction to Quality
Assurance of
Day 1: 09 Mar
Pharmaceuticals and
Monday
Health Products
13:45-14:45
14:45-17:00
17:00-17:30
09:30-11:30
QA in Practice
Tier 1 inspections,
reviews and sampling
Day 2: 10 Mar
Tuesday
QA in practice, Testing
National QA Policy and Day 3: 11 Mar
Plans
Wednesday
11:45-12:45
12:45-13:45
13:45-14:30
14:45-16:00
16:00-17:00
17:00-17:30
09:30-11:00
11:15-13:00
13:00-13:45
13:45-16:00
16:00-17:00
17:00-17:30
09:30-11:30
11:45-13:15
National QA Policy,
Plans and Manuals
Maintaining Product
Quality Throughout
the Supply Chain
Day 4: 12 Mar
Thursday
13:15-14:00
14:00-15:30
15:30-17:00
17:00-17:30
09:30-11:00
11:15-12:45
Day 5: 13 Mar 12:45-13:30
Friday
13:30-15:00
15:00-17:00
17: 00-17:30
09:30-12:00
Human Resource
Requirements
Day 6: 14 Mar
Saturday
12:00-12:15
12:15-12:45
12:45-13:30
13:30-14:30
SUB TOPICS SESSION WISE
General course introduction; student and faculty introduction
Relationship of this course to other PSM activities
Initial PSM QA knowledge and experience assessment (MCQ)
Introduction to Product Quality Assurance within the Procurement Supply Chain
Lunch Break
Product Quality Standards needed for Procurement and PSM QA
---Role of standards in PSM: What standards are available: Lack of Global Standards for
health commodities : Using DTCs to select standards
---How to reference a standard in procurement, tender and contract documents: PSM
QA monitoring and product standards
Rational QA a Total system approach using the WHO 3 Tier system
‘Policing’ approach to QA: Applying QA concepts throughout the PSM cycle: The WHO
3 Tier system: screen a lot; test a little; assay very little
Discussion and feedback
Visit to delivery bay of receiving goods warehouse, Tier 1, practical visual inspection of
pharmaceutical shipment
Tier 1, Case Study, review of manufacturer/supplier documents
Sampling of heath products–theory–random numbers–sampling rates–chain of custody
Lunch Break
Visit to warehouse store – practical sampling of health products
Types of testing, certified laboratories, WHO basic tests, Mini-Lab
Discussion and feedback
Visit to testing site – demonstration of Mini-Lab in use
Introduction to Product QA Plans and Manuals
Lunch Break
Tier 2, Visiting to QA lab, demonstration of testing techniques
Managing Product Recalls – case study
Discussion and feedback
Elements of a procurement plan (GF sample)
Practical Exercise: write a National QA Policy and Plan
QA Policy: Organize the process: Major decisions: Key Approaches
Lunch Break
Practical Exercise – write a National QA Plan
Who will – do what and pay for what?: Sampling/testing rates: Monitoring Indicators
Groups present key elements of their developed plan and policy
Discussion and feedback
Practical exercise – DTC – selecting the right products
Procuring the right products
Lunch Break
Good Storage and Distribution Practices
Practical exercise resolving storage and distribution problems
Discussion and feedback
Human Resource Requirements for PSM management and QA
HR needed for QA and how weak and inadequate HR in PSM can increase QA
problems; advocating for adequate HR in PSM
MCQ post course assessment
Discussion and feedback
Lunch Break
Graduation Ceremony
 The agenda topics, date and time estimates are subject to change. Any change in the schedule will be informed in advance through mail
ENSURING PRODUCT QUALITY IN PROCUREMENT AND SUPPLY CHAIN OF
HEALTH COMMODITIES
Bangkok (Thailand); 09-14 March 2015
Background and Details about the QA Course
Key Message of the course:
Health Commodity QA is about a complete system management approach with processes to be incorporated
throughout the entire PSM cycle.
The essence of the approach is addressing QA as an integral and essential part of the management of the PSM
process. The focus of QA should not be about testing and analysis (which, following the WHO recommendations
should only form a small, if somewhat expensive, component of QA activities.
What the course teaches:
The course is introduced and presented with the concept of understanding the management and budgeting of
the QA process and connects it with the necessary resource requirements--human, financial and capital
(equipment).
The course follows WHO guidelines for commodity QA activities and references all the prime WHO documents.
These guidelines can be applied for QA policies of the Global Fund, World Bank, UN agencies, USAID, DfiD and
other donors.
What the course does NOT teach:
The course does not teach detailed technical aspects of QA commodity analysis and operational testing
procedures.
Who would benefit from this course (recommended participants)
Public Health professionals; supply chain / logistics professionals working in procurement, warehousing,
distribution, policy, planning, quality assurance; treatment activists at national and local level; civil society
representatives; pharmacists; QA and laboratory professionals.
The course has been developed for Principal Recipients and Sub Recipients of Global Fund; National Public
Health programmes (HIV, TB, Malaria, and RMNCH); procurement and supply chain departments of Ministry of
Health; procurement agents and NGO’s.
General information:
The course is intense and the participants need to be present throughout the scheduled times. Additional selfstudy may be required in the evenings for some topics. Participants are encouraged to bring examples from
their own organizations/countries and these can be used for case studies and group work.
Course tutors are available to discuss any specific queries prior to the course, throughout the course period and
for 12 months after the course.
Expected Outcome for trainees
•An improved understanding of how to manage quality assurance of health commodities.
•The ability to formulate plans for integrating product QA activities into overall PSM activities, with guidelines
for estimating resource needs and cost estimates.
Language: Participants need to be functionally literate in English Language.
Background and details about the QA Course, Bangkok (Thailand); 09-14 March, 2015
DETAILED QA COURSE TOPICS
INTRODUCTION TO QUALITY ASSURANCE OF PHARMACEUTICALS AND HEALTH PRODUCT
SUB TOPIC
COMMENTS
 Setting the course outline and expectations.
 Introducing the key concept: QA as an integral part of the PSM process.
General course introduction
 A simple MCQ exercise to establish the overall average knowledge level of the
trainees, which is used to adjust the speed and detail level of topic delivery
 Bringing the key message that QA issues must be incorporated throughout the
Introduction to Product Quality
PSM management process; and that QA really can be effectively and efficiently
Assurance within the
managed as part of PSM management
Procurement Supply Chain
 This session does NOT require pharmacopeia knowledge or ISO experience
 The key approach is to understand the role that standards can play, their
limitations, and most importantly, how to manage their use
 It describes how to manage the use of, and correctly apply, existing international
product standards in PSM systems – especially in procurement, tender and
contract documents
 It describes how the technical process of product standards selection can be
effectively managed using Drug and Therapeutics Committee (DTC)
Product Quality Standards needed
 Key Concept: Need for total PSM system approach in QA
for Procurement and PSM QA
 Key Concept: Product QA is NOT about testing/analysis – it is primarily about
PSM management
 Key Concept: Prevention is better than cure – PSM system design to
prevent/limit QA problems – using a ‘policing’ approach
 Focus – using ABC, VEN, critical products mechanisms, to focus scarce resources
on the most challenging items
 Explaining the WHO recommended 3 tier approach to product QA for cost
control and effective management
QA IN PRACTICE TIER 1 INSPECTIONS, REVIEWS AND SAMPLING
SUB TOPIC
COMMENTS
 Explaining the WHO Tier 1 classification of ‘screening’ by using visual inspections
 Trainees will not be required to undertake technical visual product inspections
themselves – though the pharmacists will be welcome to participate if they
wish. Rather, trainees should understand the management of the process, the
Visit to delivery bay of receiving
organization and detailed procedures required, and the resource – especially HR
goods warehouse, Tier 1, practical
– needed
visual inspection of
 Trainees will be guided through the manufacturer WHO format certificates
pharmaceutical shipment
documentation review process using checklists
sampling, types of testing
 Explaining the background to sampling of health commodities – the different
rates of sampling depending on the source of the products – and the need to
operate chain of custody mechanisms and documentations
 An explanation of the different categories of product testing, which can be used,
when to use each type, costs of testing and management of the testing process
Types of testing
(certified laboratories, WHO basic tests, Mini Lab)
Background and details about the QA Course, Bangkok (Thailand); 09-14 March, 2015
QA IN PRACTICE, TESTING NATIONAL QA POLICY AND PLANS
SUB TOPIC
COMMENTS
 Trainees will not be required to undertake analysis themselves – though the
laboratory professionals will be welcome to participate if they wish. Rather,
Visit to testing site –
demonstration of Mini-Lab system
trainees should understand where such tests can be undertaken – e.g. at import
in use
receipt points – their ease of use and rapid results, together with the resources
– especially HR – needed and cost
 An outline of the concept and importance of national heath commodity policies,
Introduction to Product QA Plans
plans and manuals
and Manuals
 An explanation of the GF QA policy requirements
 Trainees will not be required to undertake analysis themselves. Rather, trainees
Tier 2, Visiting to QA lab,
should understand the connection with the chain of custody requirements;
demonstration of testing
range of tests that are undertaken; the application of product standards;
techniques
together with the resources – especially HR – needed and costs
 A guided description of a product recall scenario, emphasizing the need to have
established procedures in place before recalls occur; a clear delineation of
Managing Product Recalls – case
study
exactly who will do what; checklists; tracking procedures and managing the need
for urgency whilst ensuring correct stock control practice
NATIONAL QA POLICY, PLANS AND MANUALS
SUB TOPIC
COMMENTS
 Trainees will not be required to write an entire National QA policy/plan – that is
not practical in the time available. Rather they will be guided through managing
Practical Exercise –
write a National QA Policy and
he process of developing and maintaining a national product QA policy and
Plan QA Policy
implementation plan; the key decisions that are required; the major options
- Organize the process
available; estimating the funding costs for QA implementation and how the
whole process should be monitored
- Major decisions
- Key Approaches
 Global Fund requirements for QA policies and plans are explained during the
process
MAINTAINING PRODUCT QUALITY THROUGHOUT THE SUPPLY CHAIN
SUB TOPIC
COMMENTS
 Explain how to guide DTC product selection to consider QA factors – especially
Practical exercise – DTC – selecting
stability and deteriorating during storage and transport – so as to minimize
the right products
potential QA problems during the supply chain process
 Incorporating QA issues into procurement practice
Procuring the right products
 Cost benefit analysis of secure sourcing versus QA costs
Good Storage and Distribution
 Explanation of the WHO guidelines for GSP and GDP and how they affect QA
Practice
issues
HUMAN RESOURCE REQUIREMENTS
SUB TOPIC
COMMENTS
 Human Resources required for QA activities and effects of weak and underHuman Resources
resourced PSM systems on QA issues
 Final MCQ to measure average improvement in product QA knowledge following
completion of the course
MCQ post course assessment
 Graduation Ceremony
Background and details about the QA Course, Bangkok (Thailand); 09-14 March, 2015