The current regulatory focus on data integrity means that all personnel engaged in pharmaceutical manufacturing and testing need to be aware of regulator's expectations. Data integrity breaches can occur accidentally (e.g. through ignorance) as well as through deliberate attempts to falsify records. This course gives a comprehensive treatment of the topic to aid a compliant approach.
This course is intended for personnel involved in pharmaceutical manufacturing in a production, quality assurance or quality control function.
Lecture 1: Historical background
Lecture 2: Data integrity definitions
Lecture 3: Regulatory guidance
Lecture 4: Data integrity risks in the analytical process
Lecture 5: Exercise - reviewing analytical records for data integrity
Lecture 6: Data integrity risks in production
Lecture 1: Controlling risk in computerized systems
Lecture 2: Application examples
Lecture 3: Exercise - GAMP hardware and software categories
Lecture 4: Case studies
Lecture 5: Recent trends in regulatory enforcement action
Lecture 6: Exercise - data integrity quality risk assessment
Get fabulous discounts by participating in groups of two or more.
|1||2 Attendees||10% off|
|2||3 to 6 Attendees||20% off|
|3||7 to 10 Attendees||25% off|
|4||10+ Attendees||30% off|
To avail the above group discounts, all the participants should register by making a single payment
Call our representative TODAY on +41 - 43 434 80 33 to have your seats confirmed!