Change Management: Beyond the SOP

On this episode, Stacey Bruzzese welcomes back Dr. Siegfried Schmitt, Vice President Regulatory and Access at PAREXEL.  They discuss change management and the variety of factors that contribute to successful implementation.

 

What is included in a solid change management SOP?
What are the best practices for identifying level of risk to products or systems?
What is the best way to handle changes that are urgent, planned or temporary?
What best practices exist for pre-approvals to changes in a like-for-like change scenario?
Siegfried provides insights into streamlining the requirements of the change control process
Siegfried shares some examples of GMP deficiencies and the specific findings
What are the most important takeaways from the discussion?

Dr. Siegfried Schmitt is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems; including Quality by Design and Control Strategies since 2007. He is a Thought Leader in Competitive Compliance, Data Integrity and Supply Chain, as well as a trusted expert for regulatory, compliance and industry-best-practices projects. Siegfried has more than 30 years’ experience in the healthcare industry, spanning manufacture, analytics, validation and quality assurance. He received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland and is a Fellow of the Royal Society of Chemistry.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.