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Is My Data Abnormal? Normality Tests and Transformations

Location: California, USA
From: 2021/06/09 10:30
To: 2021/06/10 12:00
Posted by: WCS Compliance

About this event

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Training Overview

Compliance in laboratory settings has been a topic for FDA and other regulators for decades. With the increased focus on data integrity and continued focus on laboratory investigations, it is critical more than ever to ensure you have designed your laboratory operations system to meet the compliance needs of your business. In this presentation I will define compliance, provide a translation of regulations and guidance into user requirements and then using those user requirements show how one can design a laboratory system. Finally, I will provide a roadmap for implementation whether an existing laboratory or a new laboratory.

Webinar Takeaway
  • Common understanding of compliance
  • Laws, Regulations and guidance applicable to laboratory operations
  • Translation of thou shalt into system requirements
  • Processes that achieve business needs
  • Design of systems
  • Other practical considerations
  • Process mapping approach to designing a sample executable laboratory operations SOP
  • Elements of a good procedure
  • Example Process flow / SOP
  • Implementation – new lab or existing lab
Key Learning Objectives
  • Understand what Compliance means in the Pharmaceutical, Biotechnology, and Medical Device Laboratory and how that differs from Business Excellence.
  • Understanding how to translate the thou shalts of regulatory guidance and stakeholder needs into user requirements and then into system execution steps.
  • Understanding stakeholders needs and translating requirements into the design to achieve business excellence
  • Process mapping approach to designing the laboratory operations system
  • Organize the processes into meaningful systems
  • Evaluate for efficiency
  • Develop Performance Metrics
  • Create a process map for each system
  • Identify key linkages to other systems – augment maps
  • Develop the map into standard operating procedures
  • Understanding what a Process map might look like for one laboratory operations system
  • Receive a sample SOP for laboratory operation that can be translated to your operation
Who Will Benefit

Laboratory operations management. Quality Assurance Management. Designers of laboratories.

David W. Husman, Ph.D., ASQ CPGP, RAC

Experienced Consultant in Pharmaceutical and Medical Device Industries |Trainer | Based in Greenville |Open to Traveling

Taylors, South Carolina

Over 30 years of diverse international industry experience in Quality Assurance, Quality Control and Regulatory Affairs. Last 20 years as a consultant to biopharma, pharma and device industries.

Experience has spanned from R&D to Commercial Manufacture

Background includes, but not limited to, parenteral products, human tissue products, blood products, biotech products, solid dosage, vaccines, implantable devices, and in vitro diagnostic products for both human and animal species.

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