Quality Management Systems for the Pharmaceutical Industry – Fundamental Concepts. Practical aspects.

stadmin August 26, 2024 No Comments

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ROLE & RESPONSIBILITIES OF PHARMACOVIGILANCE LOCAL CONTACT PERSON

ROLE & RESPONSIBILITIES OF PHARMACOVIGILANCE LOCAL CONTACT PERSON
INTRODUCTORY COURSE - KEY CONCEPTS AND PROCESSES IN PHARMACOVIGILANCE
Qualification and validation of GxP IT systems
Quality Risk management in GxP area
Qualification and periodical evaluation of GxP suppliers
Quality Management Systems for the Pharmaceutical Industry - Fundamental Concepts. Practical aspects.
REGULATORY AFFAIRS INTRODUCTORY COURSE – MEDICINE LIFE CYCLE
GPD course – Management of non-conformities related to distributed products (medicines, food supplements, medical devices)
REGULATORY AFFAIRS INTRODUCTORY COURSE - THE ROLE OF REGULATORY AFFAIRS PROFESSIONALS IN DRUG PRODUCTS LIFE CYCLE
Good Distribution Practice. Compliance with Current Regulations – Requirements, Implementation.
DISTRIBUTION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND FOOD SUPPLEMENTS in European Union (EU) Practical approach for implementation of regulatory (GDP) requirements, by Contract Giver and Contract Acceptor
MARKETING APPROVAL of MEDICINAL PRODUCTS: Regulatory procedures & applications

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