Building a Compliant Laboratory - From Foundation to Business Excellence

Everyone struggles with getting their laboratory into compliance. Learn how to build a compliant laboratory from starting with a good foundation to implementing for Business Excellence. Dr. Husman’s presentation will walk you through the process and steps needed to ensure a compliant laboratory is built or rebuilt for business excellence.

1.    Compare what compliance means in the Pharmaceutical, Biotechnology, and Medical Device Laboratory, and how that differs from Business Excellence
2.    Understanding how to translate the thou shalts of regulatory guidance and stakeholder needs into user requirements and then into system execution steps
3.    Understanding stakeholders needs and translating requirements into the design to achieve business excellence
4.    Process mapping approach to designing the laboratory operations system can:
       a.    Organize the processes into meaningful systems
       b.    Evaluate for efficiency
       c.    Develop performance metrics
       d.    Create a process map for each system
       e.    Identify key linkages to other systems – augment maps
       f.    Develop the map into standard operating procedures
5.    Presentation of a process map for one laboratory operations system
6.    Receive a sample SOP for laboratory operation that can be translated to your operation

• Laws, regulations, and guidance applicable to laboratory operations
• It’s not just about meet the regulations, it’s getting the processes to achieve business needs
• Process mapping approach to designing a sample executable laboratory operations SOP
• Steps necessary to ensure existing laboratory and new laboratories have processes implemented that ensure compliance

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, the speaker will define compliance, provide a translation of regulations and guidance into user requirements, and then using these user requirements, he will show how one can design a laboratory system. Finally, he will provide a roadmap for implementation whether an existing laboratory or a new laboratory.

• Laboratory Operations Management
• Quality Assurance Management
• Designers of Laboratories

• David Husman has over 30 years of diverse international industry experience in Quality Assurance, Quality Control, and Regulatory Affairs. He has worked for last 18 years as a consultant to biopharma, pharma, and device industries.
• David's experience has spanned from R&D to Commercial Manufacture.
• His 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.
• His extensive experience in laboratory operations includes but not limited to auditing, development of laboratory system procedures, implementation of laboratory at a new site and forensic data integrity investigations.
• He has experience in all parts of the manufacturing operation from warehousing to packaging, from facilities and utilities to laboratories to computer systems, from regulatory to quality control. 
• He has an expert level knowledge in Compliance and Quality System development.
• He has executed numerous Data Integrity assessments and remediation projects worldwide.
• He is also a Ph.D. in Biochemistry, and is certified as a GMP expert and in Regulatory Affairs.