Organize and Presented By
Compliance Key
Sponsored By
Compliance Key
Organizing/Related Departments
Compliance Key
Organization Type
Training/Development
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
All (State/Province/Region, National & International)
Related Industries
Education/Teaching/Training/Development
Food Processing
Location
New Castle, Delaware, United States
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
Others Details
Compliance Key INC
https://www.compliancekey.us/cpg-and-retail
717-208-8666
Registration Fees
Available
Registration Fees Details
179
Registration Ways
Email
Phone
Website
Address/Venue
Online
Pin/Zip Code : 19709
Landmark
Middletown, DE, US