PRE-REGISTRATION AVAILABLE If you want to have this training scheduled Live and Exclusively for your company, we will arrange it for you. Pre-Register now and pay only once the training is scheduled on your preferred days. Click on the button below to pre-register
If you want to have this training scheduled Live and Exclusively for your company, we will arrange it for you.
Pre-Register now and pay only once the training is scheduled on your preferred days.
Laboratory Computerized Systems and data management operations are increasing in variety, sophistication, and complexity in the GxP environment.
Widespread reliance on these systems, along with their potential impact on data integrity, and the trend towards cost efficiency within companies, means that companies need achieve GxP compliance of laboratory computerized systems- within a reasonable budget and timeline.
The wide diversity of these systems, coupled with their capability for networking, makes it impractical and inefficient to have a single approach to achieve GxP compliance for all systems.
For example, a High Performance Liquid Chromatography (HPLC) with a Photo Diode Array (PDA) detector is much more complex than a pH meter, and will require a correspondingly more detailed and complex implementation, control, and maintenance approach.
Poor management of laboratory computerized system acquisition, implementation, and operation may result in:
|SEMINAR OBJECTIVES||WHO SHOULD ATTEND|
This hands-on seminar provides a practical, risk based approach to laboratory computerized system specification, verification, and implementation by:
You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:
DAY 1 (10.30 AM to 3 PM)
Lecture 1: Introduction and Background
Lecture 2: Quality Risk Management
Lecture 3: Life Cycle Approach
Lecture 4: Life Cycle Phases
DAY 2 (10.30 AM to 3 PM)
Lecture 5: GxP Compliance
Lecture 6: Risks & Implementation of Systems
Lecture 7: Supplier Documentation & Services
COURSE DIRECTOR: CAROLYN TROIANO
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.