A practical and highly interactive approach will enable participants to get actively involved, discussing guidelines and Warning Letters in addition to sharing perspectives and solutions to issues found in everyday job situations.

A kaleidoscope of hot topics such as Best Practices and Case Studies from different areas of Aseptic Processing, Sterile Production facilities, QA/ QC Microbiology Control, Shop Floor Mentoring and Oversight will be addressed. Training and Motivation of staff, use of Risk Assessments and Quality Culture are further relevant aspects.  Lively interactions will make this a valuable learning experience for all.

Learning Objectives

• Gain deeper knowledge and insights into specific topics like sterilization, training and motivation of shop-floor staff, correct aseptic working practices, media fill worst case criteria, effective environmental monitoring programs, good cleaning & disinfection practices, etc.
• Understand key requirements and challenges in parenteral production
• Understand the importance of a good quality culture within a company
• Apply the executed and presented case studies and team exercises in her/his daily job
• Get answers and interpretations about - potentially - unresolved questions and problems
• Gain confidence for audits

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