Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality, and meet regulatory requirements.
This training course will explore the essential concepts and principles of specification, design, commissioning/qualification of equipment and systems used to store and distribute water in pharmaceutical manufacturing. The course has been substantially updated to feature the guiding principles of the Water and Steam Systems Baseline® Guide (3rd Edition) with particular emphasis placed upon the new chapters for microbial control, laboratory water and rouging.
Process development for both drug substance and drug product (which includes packaging/devices), preparing a regulatory submission, and process validation activities are essential to achieving technical and regulatory success for introduction of pharmaceutical products into the market and maintaining those products over their lifecycle. Evolving requirements create ongoing challenges for both regulatory and inspectional elements. This training course on the elements necessary to ensure readiness for pre-approval inspections provides strategy and tactics towards preparation than can be customized to individual organization requirements.
Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.