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 3. Good Documentation Practices


GOOD DOCUMENTATION PRACTICES

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Sorry, registration has ended.

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Faculty: Danielle DeLucy

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 * Date: 23-08-2021 01:00 PM - 23-08-2021 02:15 PM
 * Location: Online Event

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DESCRIPTION

“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 in the Session :

 * 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
 * Interactive Q&A Session

Who Will Benefit:

 * Production Teams
 * Laboratory Teams
 * Batch record Reviewers
 * QA Auditors
 * Validation Teams
 * Quality Engineering Teams
 * Maintenance Teams
 * Warehousing Teams

 * Home
 * Recordings
 * Courses
 * About us
 * Contact
 * Terms & Conditions
 * F.A.Q's
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 * Privacy Policy
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 * Newsroom
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 * Videos
 * Seminar on DI and Part 11
 * Seminar on FDA Inspection

  Subscribe
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