Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
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| Description: | Compliance Key INC - FDA Compliance Training United States Overview Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. This 60-min Webinar covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules and principles of GDP (US & EU), General tips for Laboratory Notebook documentation and finally discussing GDP enforcement by regulatory bodies in different countries with some examples of FDA citations. Why should you attend this webinar? If you are involved in any product manufacturing, knowing GDP regulations is a must for you. It prevents a lot of errors and minimizes the chance of being spotted by the regulatory bodies in their audits. Areas Covered in the Session: Following the completion of this On-Demand Webinar you will gain a basic to moderate knowledge of definition, purpose, importance of GDP, General rules of GDP, GDP as applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029> introduction "Good Documentation Guidelines", A very brief introduction to European Union (EU) GDP, and finally its enforcement along with some observation samples from FDA. The outline of this 90 minute On-Demand Webinar includes: Definition, Purpose, and Importance General Rules and Principles of GDP Requirements of Records General Tips in GDP: Signature / initial and the meaning Copying records Document maintenance Recording the time and date Correction of errors Rounding rules Back dating Missing data Voiding / cancelling records Recreating / rewriting records Deviations Rules Governing Medicinal Products in the European Union (Vol. 4: Documentation) What is new in the Latest Version? GDP Enforcement (examples from FDA warning letters) Who can Benefit: Anybody who works in a regulated environment Manufacturing & Production Personnel / Managers Research and Development Personnel (R&D) / Managers Quality Assurance & Quality Control Personnel / Managers Laboratory Personnel / Managers Validation Specialists Clinical trial personnel Project Managers Visit:https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=1291&speakerid=239 Compliance Key INC https://www.compliancekey.us/cpg-and-retail 717-208-8666 |
| URL: | https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=1291&speakerid=239 |
| Date: | Friday, October 26, 2018 |
| Time: | 1:00pm-2:00pm UTC |
| Duration: | 1 hour |
| Access: | Public |
| Category: | Webinar*, Education* |
| Created by: | Public Access |
| Updated: | Thursday, October 18, 2018 11:30am UTC |
| : | 179 |
| : | 717-208-8666 |
| : | compliancek3@gmail.com |
| : | Ashish Prakash |
| : | 717-208-8666 |
| Comments: | None |