Live Webinar Good Documentation Practices – Real World Application

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Hear By 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."


“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.

Areas Covered

• •  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

Key Learning Objectives of your Topic:

Discover what the regulations say about documentation practices
--  Learn what your signature and/or initials mean on a document
--  See how to correct errors and omissions in data entry
--  Learn how to attach raw data to records

Dates and formats
--   Meanings of initials and signatures
--   Use of "NA"
--   Comments and explanations
--   Handling raw data (charts, strips, printouts)
--   Blanks
--   Entering numerical data

Who will Benefit

--  Production personnel
--  Laboratory personnel
--  Batch record reviewers
--  QA Auditors
--  Validation, Engineering
--  Maintenance personnel
--  Warehousing personnel

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

Danielle DeLucy

Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy 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.

Ms. DeLucy began her QA career as a quality control pharmaceutical microbiologist at Lancaster Laboratories, 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 lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, she assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.

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