Building a Compliant Laboratory - From Foundation to Business Excellence

Why Should You Attend:

FDA routinely looks at and cites laboratory operations for failure to comply with regulations, failure to have scientifically valid methods and failure to report all laboratory data. The first step in operating a compliant laboratory is establishing a structured approach that translates regulatory requirements to compliant processes. But its not just about compliance – its about building in steps to achieve business excellence. This presentation will establish the foundations and processes to achieve excellence in your business operations.

Learning Objectives:

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
1. Organize the processes into meaningful systems
2. Evaluate for efficiency
3. Develop Performance Metrics
4. Create a process map
5. Identify key linkages to other systems – augment maps
6. 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

Areas Covered in the Webinar:

• Defining Compliance
• Defining Business needs
• Build a foundation
• Translation of inputs into requirements
• Translation of requirements into processes
• Design the Laboratory Operations system
• Example elements within a comprehensive lab system
• 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

Who Will Benefit:

Regulated industries – Pharma, Bio-pharma, Medical Device – all aspects from clinical to commercial. Also applicable to companies with existing laboratories or those developing new laboratories.

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

Free Materials:

• Sample SOP – Test Execution and Review

David Husman
President and Principal Consultant, David Husman Consulting LLC

Over 30 years of diverse international industry experience in Quality Assurance, Quality Control and Regulatory Affairs. Last 18 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.

Extensive experience in laboratory operations including but not limited to auditing, development of laboratory system procedures, implementation of laboratory at a new site and forensic data integrity investigations.

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.

Expert level in Compliance and Quality System development.

Executed numerous Data Integrity assessments and remediation projects worldwide.

Ph.D. in Biochemistry, Certified as a GMP expert and in Regulatory Affairs.

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