This course is designed for people who are growing in their knowledge of pharmaceutical manufacturing. It will be a “how to” course where the instructor will explain the reasoning as well as the procedures that should be used to ensure data integrity. The instructor will present different areas for consideration and present them with a practical approach so that the participant can see how the subject matter applies to the participant’s work either now or in the future.
In addition to discussing the particular subjects the instructor will explain how pharmaceutical regulatory requirements are met through the use of proper methods for assuring data integrity. The instructor has decades of experience in working with and within the regulated pharmaceutical industry in the U.S. He has also acted as an international auditor and consultant, having worked in many countries and regions of the world. He will be covering topics that he is familiar with and will present them in a manner aimed at workers who may have little or no training related to data integrity, but now wish to raise their level of understanding.
The supervisors and workers who manufacture and assess the quality of pharmaceutical products are primarily responsible for assuring that the data they generate is accurate and reliable. This is not attained simply by having a few work procedures and rules, but also by having a culture of integrity among the responsible individuals. This seminar will provide the participant with the tools for ensuring the reliability of data, and also with ideas relating to the philosophical need for the integrity of the data.
Lecture 1: Basic Regulatory Requirements for Data
Lecture 2: Personnel Training
Lecture 3: Statistical Considerations for Reliable Data
Lecture 4: The FDA and MHRA Guidance Documents
Lecture 5: The PIC/S Guidance Document Part 1
Lecture 6: The PIC/S Guidance Document Part 2
Lecture 7: Accessing and Reviewing Electronic Audit Trails
Lecture 8: Lessons from FDA Warning Letters
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!