Skilled and Trained for the GXP Environment: Training That Works

Instructor: Dr. Wise Blackman
Product ID: 701181
  • Duration: 90 Min

recorded version

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

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

This Laboratory compliance training will provide guidance in developing training programs that meet regulatory requirements for documentation and performance of assay.

Many analysts train in undergraduate or graduate laboratories or in academic labs. This training consists of knowledge and understanding of specific assays. Documentation rules are not often understood, followed, or enforced, leaving the analyst highly skilled in performing an assay but not effectively trained for the GXP lab. This presentation will review important concepts to consider when establishing a solid training program for new analysts as wells as re-training on a consistent basis for seasoned analysts.

Areas Covered in the seminar:

  • Importance of the written method. Requirements for documentation. How to train and document the training. Causes of re-training and how to avoid multiple instances of documentation failures.
  • Documentation is a requirement for the GXP environment. Failure to document appropriately opens the door for actions by regulatory agencies.
  • Setting criteria for assay acceptance and new analyst training.
  • Software that documents training is available to monitor each analyst.

Who will benefit:

This webinar will provide guidance in developing training programs that meet regulatory requirements for documentation and performance of assay.

  • Science staff performing ssays and reviewing assays for other analysts.Primary reviewers
  • Managers certifying new analysts

Instructor Profile:

Dr. Wise-Blackman, is currently Senior Manager, Method Development and Validation, at the Catalent Pharma Solutions RTP-Bio site. Dr. Wise-Blackman leads a team that successfully develops, optimizes, validates, and performs cell-based assays for lot release and stability projects in a GxP environment She was the co-recipient of both the Customer Focus Award for 1st Quarter FY08 and 3rd Quarter FY2004 and the Presidents Award for FY2004. Her expertise is GMP bioassays to support release and stability testing of biotechnology products, GLP ELISA assay development and validation, Cell Based Screens, and Receptor Binding Assays. Dr. Wise-Blackman was previously employed at Dupont Pharmaceuticals for nine years, working in the cardiovascular pharmacology and high throughput screening departments. She received her Ph.D. in Pharmacology from the University of Virginia, Charlottesville, VA and her Bachelor of Science in Biology from the Massachusetts Institute of Technology, Cambridge, MA.

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