ComplianceOnline

Introduction to FDA Good Documentation Practices

Instructor: Chris Whalley
Product ID: 700127
Training Level: Intermediate
  • Duration: 60 Min

recorded version

$299.00
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
Last Recorded Date: Jan-2012

Training CD

$449.00
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

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This FDA Good Documentation Practices training will introduce and explain the concept of Good Documentation Practices, and provide real-world examples of how to, and how not to, use GDPs.

Course "Introduction to FDA Good Documentation Practices" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

Documentation is essential for good science. This is especially true in life sciences where FDA and other health authority regulations impose a special recordkeeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDPs) are the set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.

This webinar will to introduce and explain the concept of Good Documentation Practices, and provide real-world examples of how to, and how not to, use GDPs.

Areas Covered in the Seminar:

  • What are Good Documentation Practices?
  • How and when to apply Good Documentation Practices
  • How to complete documentation such as data collection forms and batch records
  • How to attach raw data to forms and lab notebooks
  • How to correct errors and ommissions in data entry
  • How to sign, date and label data and records

Who Will Benefit:

This webinar will provide valuable assistance to the following personnel:

  • Anyone who authors, reviews, and audits documents and records in FDA-regulated pharma, biotech, and medical device operations
  • Laboratory staff who keep notebooks and generate data
  • Clinical research associates who monitor sites and resolve CRF queries
  • Engineering and manufacturing associates who keep notebooks, generate data and execute batch records
  • Validation engineers who execute test protocols
  • Regulatory submission associates who verify submission source materials
  • Quality personnel who review raw data, lab notebooks, executed batch records, completed CRFs and other forms
  • Document control and records associates who manage documents, records and data

Instructor Profile:

Chris Whalley,

  • Principal Consultant and Founder of Doxpub, the global leader in FDA good documentation practices.
  • Member of HL7's Regulated Product Submission (RPS) Advisory Committee.
  • 12 years industry experience delivering documents, submissions, and IT systems for pharmaceutical, biologic, and medical device companies ranging from venture startups to the world's largest biotech.
  • Presenter and frequent speaker of Good Documentation Practices for laboratory, clinical, engineering, manufacturing, quality, and regulatory operations.
  • Author, editor, and publisher of hundreds of example policies, procedures, forms, protocols and reports available from www.doxpub.com
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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

Product Reviews Write review

It was a very good and interesting presentation. The presenter was clearly an expert on the topic. Of course I knew some of it already, but I also learned new stuff.
- Anonymous

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