Good (Professional) Laboratory Practices

Speaker

Instructor: David Husman
Product ID: 706646
Training Level: Beginner to Advanced

Location
  • Duration: 60 Min
This webinar discusses expected behaviors and practices for ensuring the laboratory is well managed, Personnel are safe and Results produced by the laboratory can be relied upon. The webinar discusses all aspects of laboratory management from works schedules to inventory management to testing to result and data management including roles and responsibilities of laboratory personnel.
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Why Should You Attend:

Too often presentations describe what is required by regulations without providing practical means to accomplish these. This presentation will focus on the practices and responsibilities for professional behavior in a regulated laboratory that help ensure both an efficiently run laboratory as well as developing a compliance mindset.

Regulators routinely are looking at laboratories and data generated by them. Labs are a very high activity place in our organizations that can make or break our success. To that end, there are basic principles that ensure laboratories operate in an efficient manner and that personnel operate in a professional manner. This webinar will present practices that should be followed for the operation of any laboratory, but especially laboratories performing regulated functions. The webinar will show both the practices as well as reasons why those practices are in place.

Areas Covered in the Webinar:

  • Background
  • Work Schedule
  • Personal Responsibility
  • Safety
  • Housekeeping
  • Record Keeping
  • Inventory Management
  • Sample Management
  • Testing
  • Investigations
  • Equipment Management
  • Reviewing and Releasing Data
  • Training

Who Will Benefit:

  • Laboratory analysts to laboratory management; students preparing to enter into profession.
  • Quality Assurance internal audit staff
  • 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.
Instructor Profile:
David Husman

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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