Blood and Plasma – Audits and Inspections
Im Auftrag der ECA Academy

Blood and Plasma – Audits and Inspections Im Auftrag der ECA Academy

Berlin, Germany

Seminar Nr. 17551


Kosten

ECA-Member: EUR 1590,--
Non ECA Member: EUR 1790,--
EU/GMP Inspectorates: EUR 895,--
APIC Member Discount: EUR 1690,--

Alle Preise zzgl. MwSt.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr. med. habil. Stephan T. Kiessig, Previpharma
Dr jur. Bita Bakhschai, Scheller & Kollegen
Elke Weitershaus, Government of  Saxony-Anhalt

Zielsetzung

This seminar will familiarize you with existing regulatory requirements for blood, blood products, plasma and blood products and will give you an overview of the latest changes. In addition, representatives from authorities, establishments, industry  and consultants will show you which requirements are placed on you and your quality management system during an audit or inspection and how you should prepare and follow- up an audit or inspection.

Hintergrund

As a manufacturer or supplier of medicinal products or their starting materials, blood and plasma donation establishments as well as stem cell facilities are subject to drug approval and/or drug supervision. This means that the current rules and regulations regarding the collection, storage, transportation and processing of blood and plasma products should be familiar. In addition to the current legislation some national requirements (e.g. the German Guideline on haemotherapy), the Guideline on Plasma-derived Medicinal Products, or the guidelines of the medical associations in the member states should be taken into account. Especially for establishments and responsible persons located in the medical field, the pharmaceutical legal requirements and documentation requirements often present a new challenge.

Zielgruppe

This course is aimed at employees from blood and plasma suppliers, such as blood donor establishments, transfusion centres, fractionators etc. It is aimed at the same way to blood and plasma processing companies such as pharmaceutical manufacturer. Especially employees in manufacturing, quality assurance, quality control and analytics will benefit from this course.

Programm

Responsible Persons for the Manufacture and Placing on the Market of Blood Products
  •  Manufacturer, Head of Production, Head of Quality Control, Qualified Person, Head of LQS/LQA
  •  Pharmaceutical entrepreneur, step-by-step plan officer, information officer
  •  Personal responsibility, delegation of tasks
What are Audits and what are Inspections and what is the Legal Basis?
  •  EC Blood Directives and other international Guidelines
  •  The Guideline on Plasma-derived Medicinal Products
  •  Manufacture of medicinal products from blood or plasma - Annex 14
  •  How do the different pieces of legislation interlock?
Starting Materials and Drug Products
  •  Raw material / Production / Quality control
  •  Virus inactivation/virus reduction
  •  Risk assessment for viral transmission and TSE
Drug Products from Plasma Fractionator
  •  Supplier qualification and management
  •  Quality assurance for fractionation & processing of blood products
  •  Storage and transport of blood products
Contractual Agreements with Supplier of Plasma 
  •  Key regulatory points for a contract between plasma fractionator and plasma centers/donation establishments.
Plasma Master File
  •  Plasma qualities
  •  Acceptance of blood and plasma establishments
Donor Documentation and Data Protection in Blood Establishments in the Light of the General Data Protection Regulation
  • EU General Protection Regulation,
  •  Donor documentation and archiving
Product Quality Review – PQR
  •  Regulations for a PQR
  •  Content of an PQR
    •  Deviation and CAPA Management
    •  Quality measurers in blood and plasma establishments
  •  Licensed and non-licensed products
Quality Management - Organisation and Relevant Persons
  •  Quality assurance during extraction & application
  •  Inclusion and evaluation of donors and donations
  •  Role of physicians
  •  Production, storage and transport of blood products
  •  Transfusion commissioner, responsible person for transfusion, quality officer
The forthcoming Inspection: Preparation and
  • Planning Phases
  • Inspection by the authorities
    • How to prepare for an inspection
    • How to answer on inspection reports
  • Supplier audits – qualification of contracted partners
The Procedure of Audits and Inspections Part 1 - The point of view of the blood establishment
  •  The donors‘ path through the centre
  •  Ways of the product
  •  Waste
  •  Deliveries
The Procedure of Audits and Inspections Part 2 – Inspectors‘ Point of View
  •  Inspection focus for blood and plasma facilities
  •  Responsibilities and powers of inspectors
  •  Frequent errors and defects
The Follow-up of Audits and Inspections Part 1: Inspector’s Point of View
  •  The official inspection report
  •  Category of deficiencies and their significance
  •  Opinion on the inspection report (action plan)
The Follow-up of Audits and Inspections Part 2: The point of view of the blood establishment
  • Findings
  • CAPA
  • Responsibility of the persons involved (expert person, head of production, head of QK, QM, auditor, administrative assistance)

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