Change control is a critical piece of any life sciences activity…and a global regulatory requirement. Change control deficiencies are mentioned directly or indirectly in most inspection observation findings. Compliance is a must, and a business imperative. This course will help you get on the right track with your change control programs, documentation, and overall compliance.
During process validation, setting your “number of runs” is critical to establishing defensible efforts in the eyes of regulators. This session will give you the tools to tailor that number, plus provide best practices. You will also receive helpful job aids for use long into the future.
Environmental Monitoring (EM) is a critical component to ensuring microbial contamination control in pharmaceutical product development, research, and manufacturing settings. Using a risk-based approach to EM can save money while improving efficiencies and product quality. This webinar will show you how.
Cell Therapy product development and subsequent commercialization holds limitless promise for promoting human health and company profits. However, it is a difficult and expensive task…unless you know what you are doing. Join us during this 90-minute webinar and discover the most efficient ways to product quality Cell Therapies!
This course provides practical information on contamination control and clean room management. Information is presented for the critical daily aseptic maintenance and housekeeping functions necessary to maintain required cGMP cleanliness levels.
This seminar will explore the key design concepts that are currently driving the compliance and operability of business, and an “inside-out” view of a plant’s design model including: Process Core, Facility Design, Facility Operations, HVAC, Utilities, and Construction. The course will explore modern technologies of facility deployment that can rein in costs and reduce schedules to provide you with specific guidelines that drive compliance to a successful conclusion.
This course reviews how quality systems help define requirements for aseptic techniques and cleanrooms and how to properly maintain these environments.
This course is designed to introduce a very practical, systematic approach for project execution with a view to improving the productivity, quality and minimizing rework.
This course will give you the foundational tools necessary to identify changes that need to be made, formulate a concise implementation plan that includes compliance protocols, and allows for continuous improvement.
Aseptic processing deficiencies are one of the most cited observations in FDA 483s and warning letters. Since regional regulatory bodies each have their own requirements, staying compliant can be a confusing and complex challenge.
Expansions and renovations to existing biological facilities – and construction of new facilities – provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will reduce costs and improve compliance. This webinar will discuss how process and regulations are changing the modern biotechnology facility and process design paradigm.
This course looks at key design features and philosophies that will drive compliance to a successful conclusion. Additionally, this session will explore modern technologies of facility redevelopment that can extend the life of a facility by 10 -20 years, enhance compliance to current standards, reduce the operating risks, and provide more robust plant performance.
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