A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!
cGMP for the Quality Control Laboratory
Upcoming Courses
Course Description
This web seminar will provide a general overview of the cGMP regulations that are applicable to a quality control (QC) laboratory following ICH guidelines and 21 CFR 211. We will discuss the requirements for lab equipment, such as calibration, maintenance, and validation, as well as review analytical method validation, reference standard qualification, and documentation practices. This web seminar will also cover regulatory requirements for stability testing per 21 CFR 211.166 and ICH Q1. The session will conclude with a discussion around the requirements of proper Out of Specification (OOS) investigation.
Learning Objectives
- Review the requirements of laboratory equipment, including calibration, preventative maintenance, and validation
- Review the requirements of analytical method validation, reference standard qualification, and general documentation practices
- Describe the regulatory requirements of stability testing
- Describe the requirements of investigating OOS test results
Who Should Attend
- Quality Control Staff
- Lab Management
- Lab Analysts
- Quality Assurance Staff
- Production Personnel
Instructor
Susan M. Leister, M.B.A., Ph.D., CQA, CSSBB
Click here for complete trainer biographies
Registration Fees
$835
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Accreditation Information
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-17-080-L01-P. Released: 3/17.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
