Worksheets that Capture SOP Details and Are Compliant


Instructor: Edward O Connor
Product ID: 704532

  • Duration: 60 Min
This training program will focus on understanding the drivers and benefit of using worksheets not only as a prompt for recording details but also in reducing efforts of the analysts and auditors in a GLP/GCP bioanalytical lab.
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Why Should You Attend:

This presentation will illustrate the need to capture data at a level sufficient to remove any ambiguity from process sheets and enable auditors and other reviewers to accurately reconstruct components of development, validation and sample analysis.

One essential activity is to link the process sheet directly to the method supported. This will ensure that, when the method is versioned, the process will be versioned as well.

Another component of the exercise is to reduce ambiguity. For example, a dilution sheet may require preparation of a standard using a transfer volume of 350 uL in a final volume of 5 ml, obviously there may be several ways of satisfying this requirement. The intent is to require accuracy and ease of preparing the material.

Yet another component is to differentiate the activities of reviewer, verifier and witness, and how each may be inserted in the worksheet. Finally, the construction of any process sheet should be developed towards future application in an electronic notebook, such that there is no learning curve except for the mechanics of using the entry device, a keyboard, scanner or pen.

Areas Covered in the Webinar:

  • Adding sufficient detail requests in worksheets and understanding the need.
  • Paralleling steps in SOP or analytical method in the worksheet.
  • Constructing the worksheet for future use with electronic capture.
  • Differentiating between the roles and responsibilities of preparer, reviewer, verifier and witness.

Who Will Benefit:

  • Analysts
  • Managers in regulated bioanalytical services
  • Quality advisors
  • Quality assurance
  • IT personnel

Instructor Profile:

Edward O'Connor served as director, associate director and manager of bioanalytical services and outsourcing at Oread, Microtest, Covance, TherImmune, MedImmune, Tandem, Matrix, Biogen, Elusys, Frontage, Alexion, and currently at Lovelace. His experience includes GLP, GMP, GCP and CLIA bioanalysis/ clinical chemistry.

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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 [email protected] call +1-888-717-2436 (Toll Free).




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