Making cGMP Documentation Practical

Instructor: Paula Shadle
Product ID: 700179
Training Level: Basic to Intermediate
  • Duration: 60 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: +1-650-565-8542


Read Frequently Asked Questions

This cGMP Documentation training will provide value to regulated companies required to follow strict documentation standards, whether GLP, GCP, or GMP.

Many firms struggle with repeated, basic errors in GMP documentation. This webinar discusses why certain types of errors are comonplace, and how to structure training, review, and feedback, to improve performance.Training alone is not effective; people need to understand the ’why’ behind the rules, or they will appear to be arbitrary. Here are strategies you can use, based on concepts of adult learning, risk management, and quality systems.

Areas Covered in the seminar:

  • Why is it so difficult to sustain documentation quality?
  • The human factor
  • Approaches to discussing errors
  • Peer feedback as a strong lever
  • Untrained people cannot comply well
  • Does management buy in?
  • Hints and tips

Who Will Benefit:

This seminar will provide value to regulated companies required to follow strict documentation standards, whether GLP, GCP, or GMP. The focus will be on GMP documentation. Employees who will benefit include:

  • QA and QC managers and specialists
  • All persons required to document data or observations under GLP or GMP
  • Executive management seeking to create a pro-quality culture

Instructor Profile:

Paula Shadle, Ph.D., is the founder of Shadle Consulting, a firm that specializes in quality systems and process development for biopharmaceuticals. Dr. Shadle has over 20 years of hands-on and executive experience in biopharmaceutical process development and quality at firms including Chiron, Scios, GSK and Bayer. She has published over 40 publications and is co-inventor on 4 process patents. Dr. Shadle holds a Ph.D. degree in biochemistry from the University of California, and two years’ postdoctoral experience at the Max-Planck-Institute. She is on the boards of the West Coast Chapter, PDA, and the East Bay Chapter, AWIS, and on the editorial board of BioPharm International.

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Product Reviews Write review

We received your 2 CD's from you and I personally reviewed both. The content is excellent and useful for us to train our QA and lab people.
- Anonymous

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