Good Documentation Practices

Duration: 90 Minutes
This webinar will cover the basics of what good documentation practices include, along with examples of practices not acceptable to auditors. This webinar will help attendees review their own procedures and what should be included in applicable training sessions for new employees along with refresher training for those who are more experienced.
Good Documentation Practices
Instructor: Danielle DeLucy
Product ID: 501453
Objectives of the Presentation
  • What is the definition of good documentation practices
  • Examples of documentation practices that should be avoided
  • Review of examples of good documentation practices and what they apply to
  • Review of practices for correcting mistakes or when space is limited for comments
  • Review of FDA 483 citations given to companies
Why Should you Attend
"Good documentation practices" is a "current" industry practice that is reviewed and cited by federal regulators when audited. Pharmaceutical/Biological document are legal documents that are controlled by all regulatory agencies. The person or persons responsible for filling out these documents accepts the consequences if the documents are not filled out according to good documentation practices. Good documentation practices are expected to assure they are accurate, legible and traceable to name a few. The lack of such good documentation practices are routinely cited in FDA 483 observations. Attend this webinar to learn proper methods for documenting data in the highly regulated pharmaceutical industries.

Who can Benefit
  • Quality Control Personnel & Management
  • Manufacturing Personnel & Management
  • Senior Management
  • Regulatory Affairs Personnel & Management
  • Quality Assurance Personnel & Management
  • Supplier Quality Personnel & Management
$300
Recorded Session for one participant
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Live Session - How it works
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  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
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  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.
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