Quality in the Laboratory: It’s in the Details Expert Panel Discussion – LIVE FREE Webcast
Quality in the Laboratory: It’s in the Details Expert Panel Discussion
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Areas For Discussion
Quality is the basic principle in the laboratory so why do laboratories have issues with executing complete, effective and compliant quality processes? This webcast will include a discussion of critical elements needed to achieve a functioning quality program that is not only compliant but also does the job of assuring quality results. Real life examples will be included. Key elements:
- Over watch: Familiarity breads complacent practices
- Training: training has multiple facets from understanding the process to the execution of the task to carrying out the task under normal workload.
- Documentation: What is documented, where it is documented and how it is documented.
- Data: What to track and trend
- Out of Specification Investigations: due diligence in the laboratory investigation
- Equipment Life Cycle: Purchase to retirement
- Qualification: Process and equipment Validation/verification
Who Will Benefit
Industry professionals from many areas, including:
- Quality Assurance/Quality Control
- IT Professionals
- Technical Operations
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Our Expert Panel Biographies
Dr. James Blackwell, MBA is The Founder, President and Principal Consultant of The Windshire Group. Dr. Blackwell has been a prominent industry consultant for over twelve years, working on a wide variety of CMC and quality issues for a broad range of companies, investors, and product types at all stages of the product life cycle. Prior to consulting, he held several senior positions in technical operations, manufacturing and process development at prominent operating companies.
Dr. Blackwell is trained as a scientist, engineer and businessman. He received his Ph.D. in Chemical Engineering from Northeastern University. He received his dual M.B.A./M.S. Technology Management from the University of Maryland, and graduated with B.S. Chemical Engineering and M.S. Microbiology degrees from The Ohio State University.
Deborah Miller has had positions of responsibility and authority in regulated environments for over 30 years. She has diverse and extensive regulatory experience in assessment, remediation and fostering quality and compliance for biotechnology, in-vitro diagnostics, medical device, blood and plasma establishments and clinical and forensic laboratories. Deborah has been supporting development and operational teams in turning quality theory into practice as a consultant in Quality Management Systems for 12 years. She is a retired U.S. Army Medical Service Corps Officer and has a Master’s Degree in Laboratory Medicine from the University of Washington, Seattle.
Mark is a board certified anatomic and clinical pathologist and a former licensed healthcare risk manager, nuclear medicine technologist, and clinical engineer. Dr. Gusack has experience in the laboratory field including medical directorships, staff positions, laboratory startups, laboratory inspections and laboratory licensing. He has also worked as an independent consultant in laboratory medicine, pharmaceuticals, information technology, and knowledge management. He was a consultant to the Clinical Laboratory Standards Institute on EP23 in 2010 – 2011 resulting in standards for using quality control as a means of risk management. He is presently an ISO 15189 assessor for the A2LA.
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