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Good Documentation Practices

18-July-2024 :01:00 PM EDT Duration : 60 Minutes

Danielle DeLucy, Pharmaceuticals, Biotechnology

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, suc Read more

“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. 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.

Course Objectives:

The standard of documentation within a company can directly impact the level of success in achieving approval of drugs and manufacturing quality products that are safe.

Course Outline:

• 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 give to companies

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Production Teams

• Laboratory Teams

• Batch record Reviewers

• QA Auditors

• Validation Teams

• Quality Engineering Teams

• Maintenance Teams

• Warehousing Teams

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register


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