Basics for Hygiene Officers in the GMP Environment

The Cleanroom Competence Center of Rohr AG offers a new seminar starting in 2019: "Fundamentals for Hygiene Officers in the GMP Environment" for the pharmaceutical industry and medical technology. The seminar focuses on imparting knowledge essential for the role of a hygiene officer.

The Seminar

Regulatory authorities impose strict requirements on manufacturers of medicinal products (drugs and medical devices). The revised Annex 1 "Manufacture of Sterile Medicinal Products" significantly tightens the regulations for pharmaceutical manufacturers in many details. Newly incorporated are the principles of the "Pharmaceutical Quality System - PQS" from GMP Part 1 and ICH Q10 into Annex 1, along with terms such as "Quality Risk Management (QRM)", "Root Cause Analysis", and "Risk Assessment". Especially in the area of hygiene, a risk-based approach and risk management play a crucial role. To prevent gaps between different competencies, a person should dedicate themselves exclusively to hygiene and all related tasks. To this end, Rohr AG's Cleanroom Competence Center has developed a seminar that, based on a fictional job description, imparts the necessary knowledge.

Drawing on their many years of experience, Rohr AG's experts know exactly which risks need to be particularly considered. The focus of the seminar is therefore on providing knowledge that a hygiene officer in the pharmaceutical industry needs to fulfill their daily tasks. The topics are covered in theory and practiced with practical examples. Participants have the opportunity to bring in questions and concerns from their everyday work.

Content

The content is structured according to Ishikawa's cause-and-effect diagram and considers all factors that could negatively impact the quality of the manufactured products. These include the quality-determining factors:

• - People
• - Machines
• - Materials
• - Environment (Production Environment)
• - Methods (Processes)
• - Measurement (Quality Assurance)

Target Groups

Employees from companies in the pharmaceutical industry, manufacturing pharmacies according to HMG, medical device manufacturers, and their suppliers who are responsible for hygiene in their company and act as contact persons for hygiene questions within their organization.

Registration

Online registration at: www.rohrag.ch/hygiene-seminare