Outsourced Activities and Responsibilities of the Licence Holder and Responsible Person
£149.00 Excl Tax
This course looks at Outsourced Activities relating to Good Distribution Practice, along with the Responsibilities of both the Responsible Person and Licence Holder as per requirements of the GDP Guidelines and Human Medicines Regulations 2012.
CHAPTER 7 — OUTSOURCED ACTIVITIES
7.1. Principle
Any activity covered by the GDP guide that is outsourced
should be correctly defined, agreed and controlled in order to
avoid misunderstandings which could affect the integrity of the
product. There must be a written contract between the contract
giver and the contract acceptor which clearly establishes the
duties of each party.
This course looks at Outsourced Activities relating to Good Distribution Practice, along with the Responsibilities of both the Responsible Person and Licence Holder. Including areas such as the quality system and risk management with details from the Human Medicines Regulations and the EU Guidelines on GDP.
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