The presentation will include: where GDP can be found in the CFR, We will discuss definitions of documentation, raw data, record keeping, and some do's and don't's.
We will discuss what the CFR requires and how to interpret what the CFR states.
We will discuss how to write in forms and notebooks, what must be included in the SOP and where to find this information, whether in the CFR, USP, FDA or other sources.
Why you should Attend: Why attend? Those in quality must have a solid background in GDP. It is the lifeblood of Quality. FDA inspections can focus on the little things, like GDP, as poor GDP targets the focus of the inspection onto more items.
Little things in GDP include how to write, what to write, the ability to read what is required, and what does FDA expect.
Poor GDP leads to disaster. Good GDP can show the inspector that systems are in place and well managed.
In addition to how to write and where to write, a thorough discussion on how to handle raw data and where to find information.
Areas Covered in the Session:
- Basic documentation
- Raw Data
- Record keeping
- Do's and Don't's
Who Will Benefit:
- Quality
- Manufacturing
- Regulatory Affairs
- QA/QC/RA
- R&D
Speaker Profile
Courtland Imel is CEO of Ceutical Laboratories. Courtland has provided training to FDA, Health Canada, and state regulatory authorities. Courtland has spoken at AFDO, AFDOSS, MCAFDO, ASQ, SCC, and Bio. Courtland has 35 years of experience in the industry. Courtland is an SME for several organizations and law firms. Courtland worked for M&M Mars, Allergan, ILEX Oncology, Aronex Pharmaceuticals, Mills Biopharmaceuticals, International Isotopes, Avail Medical Products, Carrington Laboratories, and Ceutical Laboratories, Inc. Courtland has assisted in the submissions of 510Ks, PMAs, IND’s, NDAs, ANDAs, IDEs, and more.
Ceutical Labs provides many services including product development, formulation development, analytical testing (chemistry, microbiology, and physical), regulatory submissions, electronic submissions, consulting, training, quality systems, and more.
Event link:
https://www.compliance4all.com/webinar/-502880LIVE?channel=%20qualitymag%20-FEB_2020_SEO
Contact Info
Netzealous LLC,DBA -Compliance4all
Email: [email protected]
Phone: +1-800-447-9407
Website: https://www.compliance4all.com/