Equipment Lifecycle Management

Summary

This course is a deep dive into the lifecycle of pharmaceutical equipment for different dosage forms. Machinery for tablets,
ointments and liquid sterile products are being explained and discussed. The training focuses on the connection between
engineering, quality and safety aspects of pharma & biotech equipment. Moreover, the training addresses specific aspects
for lab equipment, computer system validation and process validation. Finally, operations, maintenance, deviations
and changes are being discussed to complete the lifecycle of pharmaceutical equipment.

Learning Objectives

• Regulatory overview
• Basics and newest developments in the field of qualification
• What is the role of the equipment in the fields of validation like process and method validation
• Modern equipment designs and what to consider
• Newest technologies like Continuous Manufacturing and PAT
• Focus on laboratory and process equipment in the fields of medicinal products and medical devices

Key Topics

• Regulatory Landscape and what is important
• Equipment Designs
• Equipment Qualification
• Validation and equipment
• Newest technologies and developments in the equipment fields like
• Continuous Manufacturing and Process Analytical Technologies
• Facilities and utilities
• Data Integrity requirements
• Computer System-Validation requirements
• Equipment Lifecycle and operations

Who should attend?

Quality Assurance Manager; Quality Control Manager; Engineering Specialists; Regulatory Affairs Manager; Qualification Specialists; Manufacturing Management; Process Development; Research and Development; For Medicinal Products and Medical Devices

Our online training experience includes

• Our client zone – a single source for all training materials as well as pre and post-training communication
• Live interactive format via the Zoom platform
• Direct interaction with the trainer
• Q&As, case studies, polls
• Training in digital format
• Digital and LinkedIn certificates