Complying with FDA's Good Documentation Practices [It Didn't Happen]

Pre Recorded

  • 90 minutes

Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety. Documentation provides both:

  • Information on when, where, who, why and how to complete tasks

  • Evidence proving that the tasks have been completed as they should be.

Join this session with expert speaker Angela Bazigos, where she will discuss how to write or record information in a compliant way (includes text, numbers, electronic signatures, etc)

Session Highlights:

  • Basics of Good Documentation Practices

  • Documents vs records

  • How to amend documents or records in a compliant way

  • Specific contents will include but are not limited to:Document Creation

  • Document Approval

  • Handwritten Entries

  • Copies of Documents

  • Document Maintenance

  • Document Modification

  • Warning Letters for GDocP

Why You Should Attend:

As the FDA and TGA say “If it isn’t written down, then it didn’t happen” To meet industry standards, it is critical that all documentation follows GDP when it affects:

  • GMP / GLP / GCP processes

  • Material or product identity, quality, purity, strength, and safety

  • The validated state of GMP / GLP / GCP product manufacture, facilities, equipment, computer systems, and testing methods.

It is recommended that your company has a policy or procedure outlining the expected GDocP standards, particularly for those requirements that may be unique to your company – for example, using a specific pen color or when and how to use scanned documents/records as original data.

Who Should Attend:

GDP's are meant for use in the production and control of Active pharmaceutical ingredients (APIs), Medical devices, Excipients, Pharmaceutical products, Labs, Dietary supplements and Food ingredients:

  • Regulatory

  • Compliance

  • Audit

  • Quality

  • R&D

  • Scientists

  • Documentation and Validation

  • Clinical Research

  • Lab Managers

  • Engineering and Manufacturing

*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Angela Bazigos

Angela Bazigos

Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and Pricewater house Coopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry. Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.

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