Building a Compliant Laboratory - From Foundation to Business Excellence

Instructor: David Husman
Product ID: 706396
Training Level: Basic to Advanced
  • 10
  • June 2020
    Wednesday
  • 10:00 AM PDT | 01:00 PM EDT
    Duration: 90 Min
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.

Live Online Training
June 10, Wednesday 10:00 AM PDT | 01:00 PM EDT | Duration: 90 Min

$249.00
One Dial-in One Attendee
$629.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Super Deal - Get CD/USB Drive Free!

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD / USB Drive

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$429.00

Live + Training CD/USB

$529.00

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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
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.
  • Follow us :
    Quality Control Laboratory Compliance

    Refund Policy

    Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

    Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

    If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

    We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

    Product Reviews

    This product hasn't received any reviews yet. Be the first to review this product! Write review

    Best Sellers
    You Recently Viewed
      Loading