Organization Name / Organize By
Training Doyens
Organizing/Related Departments
Life Science
Organization Type
Organization/Company
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
All (State/Province/Region, National & International)
Related Industries
Education/Teaching/Training/Development
Business Development
Biotechnology
Medical/Healthcare/Hospital
Location
Aurora, Colorado, United States
OVERVIEW
FDA requires that all documentation related to GxP (GMP, GLC, GCP) products be created and maintained in accordance with specific rules. From the color of the ink used to the FDA labeling requirements, you’ll learn all about how to create and maintain good FDA-compliant documentation.
The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the validation deliverables for computer systems regulated by FDA and how to document them through the entire process.
WHY SHOULD YOU ATTEND
You should attend this webinar if you are responsible for any FDA-regulated data and/or records. All documents need to be created and maintained in accordance with FDA guidelines for good documentation to avoid any issues during an inspection or audit. You will also benefit from learning about the guidelines for computer system validation and the many deliverable documents that need to be produced in a way that is FDA-compliant. Having completed this course, you will be on your way to successful future FDA audits and inspections.
AREAS COVERED
- FDA Good Documentation Practices
- Computer System Validation (CSV)
- System Development Life Cycle (SDLC) Methodology
- GAMPV System Categorization
- Industry Best Practices
- Potential Pitfalls
- Q&A
LEARNING OBJECTIVES
- To understand how to create, revise and maintain documentation that is FDA-regulated.
- To understand the many deliverables required to complete a computer system validation effort.
- To understand industry best practices.
- To understand and avoid potential pitfalls.
WHO WILL BENEFIT
- Information Technology Analysts
- QC/QA Managers
- QC/QA Analysts
- Clinical Data Managers
- Clinical Data Scientists
- Analytical Chemists
- Compliance Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Managers
- Manufacturing Supervisors
- Supply Chain Specialists
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
- Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
- Auditors engaged in the internal inspection of labeling records and practices
All FDA-regulated industries:
- Pharmaceutical
- Biologicals
- Medical Device
- Tobacco
For more detail please click on this below link:
https://bit.ly/2QA7Ezs
Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
Others Details
Learn the basics of creating and maintaining documentations as per FDA regulations. Also learn about documenting Computer System Validation according to the FDA guidelines
Registration Fees
Available
Registration Fees Details
Live Session
for one participant
$199
Corporate Live Session
Group – Max 10 Participants from one location.
$549
Recorded Session
Get unlimited access to the link for six months.
$219
Training DVD or USB Flash Drive
MP3 files, PDF presentation and reference manual will be delivered on a CD
$399
Super Combo Offer 1
Live and Recorded webinar
$329
Super Combo Offer 2
Live and Training CD
$499
Registration Ways
Email
Phone
Website
Other
Address/Venue
Training Doyens 26468 E Walker Dr,Aurora, Colorado
Pin/Zip Code : 80016-6104