Worksheets that Capture SOP Details and Are Compliant

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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