Organization Name / Organize By
Training Doyens
Organizing/Related Departments
Training Doyens
Organization Type
Organization/Company
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
All (State/Province/Region, National & International)
Related Industries
Biotechnology
Medical/Healthcare/Hospital
Location
Denver, Colorado, United States
OVERVIEW
This FDA compliance 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 various computer system validation deliverables and how to document them through the entire process.
FDA requires that all documentation related to GxP (GMP, GLC, and GCP) products be created and maintained in accordance with specific rules. From the color of the ink used to the retention requirements, you’ll learn all about how to create and maintain good FDA-compliant documentation.
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
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
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.
For more detail please click on this below link:
https://goo.gl/t1wg51
Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
Others Details
Attend this FDA compliance webinar and learn the guidelines for computer system validation and the many deliverable documents that need to be FDA compliant.
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 audio recording of the webinar for 6 months.
$219
Training CD
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
26468 E Walker Dr, Aurora, Colorado 80016-6104
Pin/Zip Code : 80016