Course Leader: Dr. Afshin Hosseiny (Bsc. Msc. Ph. D. C. Chem MRSC M.inst. Pkg)

The pharmaceutical industry has the responsibility not only to manufacture effective and safe products, but also to ensure that they are delivered to the patient in a safe and controlled manner. Management of the supply chain is a critical activity which requires adequately designed facilities, documentation systems and trained staff. This two day training course will cover the regulatory requirements developed by the EU and USA regulators as well as the WHO (World Health Organisation). Delegates attending this course will be provided with information on how to design and manage warehouses, select contractors, temperature map their warehouse, develop temperature monitoring system and manage transportation of their products. In addition guidance will be given on preparing SOPs, documentation and preparing facilities for EU/USA regulatory inspections. Interactive workshops especially designed to enable participant exchange views, share experiences with others and, our expert tutor while being guided through key aspects of pharmaceutical supply chain management. You will have a unique opportunity to discuss your GDP problems with our tutor who has over 20 years experience in this field.

This two day course will be of interest to the following industries:

• Pharmaceutical/veterinary manufacturers
• Biotech manufacturers
• Vaccine manufacturers
• Suppliers of vaccines
• Healthcare providers
• Supplier of services to the above industries
• Hospital management
• Wholesalers
• Production managers
• Qualified Persons/Responsible Persons
• Project Managers
• Procurement Managers
• Quality Assurance managers/Quality Control Managers
• Supplier Auditors
• Regulatory Affairs Personnel
• Distribution/Transport/Logistics Managers
• Professionals from Distribution and Logistics Functions
• Contract Warehouse Managers

PROGRAMME

Regulatory requirements

• EU Directives
• WHO Guidelines
• UK MHRA Guidelines
• EU Legislations on Wholesale Distribution
• EU Guidelines for Wholesale Distribution Practice
• Role of Qualified Person and Responsible Person

Session II

Premises and facilities

• Facility design
• Cleaning & ‘cleanability’
• Security and product integrity
• People movement
• Materials movement
• Product segregation
• Control of contamination/cross contamination
• Temperature control & Monitoring – what is required

Personnel

• Staff selection and qualification
• GDP/GMP training
• SOP Training
• Training records

Session III

Quality Systems

Documentation

• Definitions
  • Orders
  • Procedures
  • Records
• Document control and maintenance
• Document Archiving
• Preparing training packages

Procedures

• Identifying what is required
• how to develop a standard format and structure
• writing SOPs
• critical SOPs for a warehouse
• preparing SOP training packages

Non Compliance Management

• investigation of non-compliance
• reporting and documentation
• corrective action and preventive action planning (CAPA)

Returns Management

• returns of non-defective medicinal products
• security and QA decision

Emergency Planning and Recall

• recall procedure
• investigation and reporting
• corrective action planning

Sampling

• facility requirement
• control of product and facility contamination
• documentation

Stock Management

• stock management via FIFO/FEF
• cycle counting

Packaging & Re-labelling

• facility and equipment requirements
• SOPs and Documentation
• staff training

Warehouse Management System

• Developing specification
• Vendor selection
• Validation

Self Inspection

• regulatory expectations
• checklists
• reporting and action planning

Contractors

• Decision process for outsourcing
• Contractor selection process
• Quality/Technical agreement
• Contract considerations
• Audits of contractors

Session IV

Transportation

• Modes of transportation and challenges they offer
  • Air
  • Land
  • sea
• Vehicle design consideration
• Security issues
• Temperature monitoring & control
• Non compliance reporting and action planning

Session V

Cold Chain Management

• Developing specification
• Facility design consideration
• Transport issues
• Packaging options
• Monitoring during storage and transport
• Developing procedures
• Training and control
• Dealing with out of specification situations

Temperature Mapping

• What to consider when mapping your warehouse/trailer
• Design considerations
• Developing plans
• Test protocols
• Identifying the risk areas
• Planting the temperature monitors
• Collating data and data evaluation
• Reporting – developing recommendations
• How to maintain the qualified status -On going maintenance

Session VI

Preparing for Inspections

• Developing self inspection programme
• Training issues
• Internal audits
• Action planning
  • Root cause analysis
  • Preventive action
• Maintaining inspection readiness status

Inspection findings

• Most recent regulatory and client inspection findings

COURSE LEADER