Introduction to FDA Good Documentation Practices

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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