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Advanced Good Distribution Practice + Temperature Controlled Logistics ~ Cold Chain 

good distribution practices for pharmaceutical medical device diagnostics hospital healthcare wholesalers distribution supply chain logistics material department transportation Airports Courier Airfreight Shipping Ports Storage Warehousing pharmachemical starting material counterfeit medicines life science GDP GxP GMP GCL Clinical Material products pharma chemical patience protection Good manufacturing practice Good Clinical Practice Good laboratory Practice World Heath Organisation WHO MRHA The Community pharmaceutical industry operates at a high level of quality assurance, achieving itsThis level of quality should be maintained throughout the distribution network so that authorised medicinalIn addition, to maintain the quality of the products and the quality of the service offered by wholesalers,The quality system operated by distributors (wholesalers) of medicinal products should ensure thatPersonnel A management representative should be appointed in each distribution point, who should have defined authority and responsibility for ensuring that a quality system is implemented and maintained. He should fulfil his responsibilities personally. This person should be appropriately qualified: although a degree in Pharmacy is desirable, the qualification requirements may be established by the Member State on whose territory the wholesaler is located

Duration:       Intensive 3 Day Program 

Dates:         Next Course Monday 27th Tuesday 28th Wednesday 29th of September

Location:       28 Merrion Square Dublin 2 Ireland 

2 Days ~ Advanced GDP + Temperature Controlled Logistics

1 Day ~  GDP Compliance in Practice & Regulatory Inspections

Accrediated by Institure of International Trade of Ireland the Research & Training Body of the Irish Exporters Association

Course Outline 

Advanced GDP + Temperature Controlled Logistics  (Monday/Tuesday)

This course offers a practical explanation of the current guidelines for those who are active in the field of setting up and/or implementing GDP, as well as the management of quality systems and the supply chain for Pharmaceutical & Medical Device products. The training workshop is highly interactive aimed at individuals who wish to increase their knowledge and understanding of the current requirements of GDP.

A management representative should be appointed in each distribution point, who should haveKey personnel involved in the warehousing of medicinal products should have the appropriate abilityand experience to guarantee that the products or materials are properly stored and handled The Community pharmaceutical industry operates at a high level of quality assurance, achieving itsPractice for medicinal products and should be considered when relevant for the distribution ofPersonnel A management representative should be appointed in each distribution point, who should have defined authority and responsibility for ensuring that a quality system is implemented and maintained. He should fulfil his responsibilities personally. This person should be appropriately qualified: although a degree in Pharmacy is desirable, the qualification requirements may be established by the Member State on whose territory the wholesaler is located.Key personnel involved in the warehousing of medicinal products should have the appropriate abilityOrders from wholesalers should be addressed only to persons authorised to supply medicinal

Training Objectives

This two day training course aims to offer participants a comprehensive understanding of Good Distribution Practice (GDP) & Temperature Controlled Logistics(TCL)  in relation to the guidelines and directives of the Irish Regulatory Authority (Irish Medicines Board-IMB) and other International Regulatory Authorities including EMEA & FDA.

  • Understand the regulatory requirements and constraints facing manufacturers in the management of the supply chain from sourcing to final distribution (Bona fides of suppliers and customers).
  • Become familiar with EU 94C 63/03 Guidelines and the Irish Medicines Board (IMB) Guidelines on GDP and the expectations of the regulator. 
  • Identify the controls necessary to ensure compliance with GDP along the supply chain including all facilities used
  • Latest expectations on Temperature Controlled Logistics, including a review of Temperature Mapping, Temperature Management, Route Qualification and Cold Chain requirements.

Topics Covered 

  • Quality systems
  • Standard Operating Procedures (SOPs)
  • Records
  • Premises and Equipment
  • Receipt
  • Storage
  • Deliveries to Customers
  • Distribution
  • Transportation
  • Temperature Management
  • Returns Management
  • Recalls Management
  • Traceability and importance
  • Supply Chain Visibility
  • Counterfeit Medical Products
  • Security and transit requirements

 Basic Rules of Temperature Controlled Logistics 

  • Terminology
  • Temperature Mapping
  • Temperature Monitoring
  • Route Qualification
  • Excursions and how these should be managed
  • Documentation
  • Validation: Equipment & Calibration          
  • Designated Responsibility
  • Transportation modes
  • Audits / Self Inspection
  • Quality Systems

Written procedures should describe the different operations which may affect the quality of theRecords should be made at the time each operation is taken and in such a way that all significantPremises and equipment should be suitable and adequate to ensure proper conservation andStorage Medicinal products should normally be stored apart from other goods and under the conditions specified by the manufacturer in order to avoid any deterioration by light, moisture or temperature. Temperature should be monitored and recorded periodically. Records of temperature should be reviewed regularly. When specific temperature storage conditions are required, storage areas should be equipped with temperature recorders or other devices that will indicate when the specific temperature range has not been maintained. Control should be adequate to maintain all parts of the relevant storage area within the specified temperature range. The storage facilities should be clean and free from litter, dust and pests. Adequate precautions should be taken against spillage or breakage, attack by micro-organisms and cross contamination. There should be a system to ensure stock rotation (Deliveries should be made only to other authorised wholesalers or to persons authorised to supplyReturns of non-defective medicinal products Non-defective medicinal products which have been returned should be kept apart from saleable stock to prevent redistribution until a decision has been reached regarding their disposal. Products which have left the care of the wholesaler, should only be returned to saleable stock if:a) the goods are in their original unopened containers and in good condition;b) it is known that the goods have been stored and handled under proper conditions;

Course Outline ~ GDP Compliance in Practice & Regulatory Inspections (Wednesday)

The aim of the course is to clarify GDP concepts and to help delegates get a feel for what questions inspectors might ask during regulatory audits, and what systems and practices they expect to see.  In addition, it incorporates guidance on how those in positions of responsibility might go about ensuring compliance on a day-to-day basis, and also the right approach to preparing for, and dealing with, regulatory inspections.  

Training Objectives 

  • Consolidation of understanding of GDP principles
  • Developing an awareness of what compliance means in practice
  • Understanding the regulatory inspectors’ expectations
  • Review typical deficiencies identified by the regulator 

Topics Covered 

  • Overview / Summary of GDP principles
  • Why quality systems?
  • What is a Quality System?
  • Where does ISO fit?
  • SOPs (Standard Operating Procedures)
  • Documentation
  • Change control
  • CAPA (Corrective Action / Preventative Action)
  • Regulatory Audits and Self Inspection  

Course Details

Overview / Summary of GXP principles - Clarification of terms - how GDP fits with GMP

Why quality systems?

Focus on patient safety - but also business considerations

Overview of GDP risk areas

 Importance of the human factor

What is a Quality System? (i.e  The importance of integrating the QS into the business)

Where does ISO fit? (i.e. ISO / GDP comparison in terms of inspections)

Standard Operating Proocedures (SOPs)

The basics of SOPs in practice - what they should cover / how they should be controlled

Auditors' expectations

Documentation - Basic requirements / what auditors look for / what a signature means

Change control -  Basic requirements - what needs to be considered in practice

CAPA - Basic principle and approach / how CAPA expectations are often not met

Regulatory Audits and Self Inspection - Requirements for self-inspection / how to carry them out in practice / audit readiness / typical Regulator's approach to audit / common deficiencies

Control of defective materials & Control of product returns

The aim of the course is to clarify GDP concepts and to help delegates get a feel for what questions inspectors might ask during regulatory audits, and what systems and practices they expect to see.  In addition, it incorporates guidance on how those in positions of responsibility might go about ensuring compliance on a day-to-day basis, and also the right approach to preparing for, and dealing with, regulatory inspections. The theme of the training emphasises that compliance is a cultural issue - it must be led.  The role of managers / supervisors in doing this.  The importance of self-audits in getting the message across.

Course Design & Accreditation

Certificate of Completion is accredited by Institute of International Trade of Ireland (IITI) the Research & Training Body of the Irish Exporters Association- IEA (a Fetac approved training body). The Course was designed in consultation with IMB and inline with GDP Manufacturers Code of Practice (IEA).

Course Format

The Course runs each day from 9 - 5.00 pm  and consists of formal content presentation interspersed with content quiz sessions. The presenters’ style involves intensive audience participation.

Course Fees

Advanced GDP + TCL  ~ Monday 27th & Tuesday 28th of September 2010 ~ €1,350 (2 days)

GDP Compliance in Practice & Regulatory Inspections ~ Wednesday 29th of September  2010 ~ €750 (1 day)

Advanced GDP + TCL + Compliance in Practice & Regulatory Inspections ~ € 1,950 (3 days)

For further information contact Patrick O'Loughlin Course Director

+353 1 2800437 or Mobile + 353 86 2600227 Email: info@gdptrainingservies.ie

 Good Distribution Compliance in Practice and Regulatory Inspections Ensuring your Quality Procedures and Systems comply with your Wholesalers Authorisation and GMP Manufacturing Licence

Good Distrubution Practice keep up to date with the latest guidlines required to ensure compliance with your Wholesalers Licence

Cold Chain Temperature Controlled Logistics Public Training Course Keep up to date with latest developmemts in regulatory complaince

The Regulatory Authorities IMB MRHA FDA are now looking for Drivers and Couriers of Medicinal Products to have received training in GDP

Regulatory Training and Compliance Quality Consultancy Services Life Science Training Services Compliance and Regulatory Affairs meeting FDA IMB MRHA WHO Authorities

PharmaCareers is specialist division of the O'Loughlin Partnership engaged in assisting individuals with career advisory and training seeking a career move to the Life Science Industry Pharmaceutical Medical Device Biopharmaceuticals Diagnostics Healthcare

Executive Recruitment Services O'Loughlin Partnership 

Interim Pharmaceutical Placement Services  

An emergency plan for urgent recalls and a non-urgent recall procedure should be described inAny recall operation should be recorded at the time it is carried out and records should be madeIn order to ensure the efficacy of the emergency plan, the system of recording of deliveries shouldThe same system should apply without any difference to deliveries in the Member States havingIn case of batch recall, all customers (other wholesalers, retail or hospital pharmacists and persons entitled to sell medicinal products to the public) to whom the batch was distributed should be informed with the appropriate degree of urgency. This includes customers in other Member States than the Member State having granted the wholesaling authorisation.The recall message approved by the holder of the marketing authorisation, and, when appropriate, by the competent authorities, should indicate whether the recall should be carried out also at retail level. The message should request that the recalled products be removed immediately from the saleable stock and stored separately in a secure area until they are sent back according to the instructions of the holder of the marketing authorisation. Counterfeit medicinal products

NIM Consultants Limited Company Registration Number: 33316   trading business name Good Distribution Practice Training Services No. 346650



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