Enjoy this webinar on your own time at your own pace!
Defensibility of data is a key issue in the laboratory. Laboratories reporting data for regulatory bodies are required to train employees in data integrity and ethics to ensure that proper laboratory technique is used for generating data. The training will cover common indicators for laboratory fraud and how the supervisor or data reviewer can develop a program to ensure data generated in their laboratory is defensible and complete. An in depth internal auditing program is important to discover and rectify any evidence of laboratory fraud. And real world examples and a checklist will be demonstrated to aid in the effective auditing of integrity practices. Employees rarely choose to commit fraud in the laboratory and it is usually the lack of knowledge on proper record keeping or technique. Education provides best practices and establishes expectations for the proper method of testing and reporting sample information. Fraud can impact all industries. This course will address data integrity and ethics in the laboratory.
This class will meet the requirements for initial and annual employee Data Integrity training for TNI and QSM/DOD.
Pharmaceutical, Environmental (TNI and QSM/DOD), Commercial, and Plant Managers.
This highly participative 2-day course provides comprehensive instruction on auditing quality management systems based on the ISO 9001:2015 requirements. The course begins with a high-level overview of the differences between ISO 9001:2015 and ISO 9001:2008. Through practical workshops, case studies, and simulated assessments you will develop an understanding of how the new requirements will affect your organization and your audits. The training will teach process based audit skills, which are useful in internal and external audits. Additionally, by using real-world audit situations, you will practice your auditing skills and techniques to help you fully understand the requirements of auditing to the ISO 9001:2015 standard.
Student Prerequisites: Each student shall be required to have studied the current published version of ISO 9001:2015 prior to attending the course. Please bring a copy of the standard with you to the course.
Student Prerequisites: Each student shall be required to have studied the most newly revised version of ISO/IEC 9001:2015 prior to attending the course. Please bring a copy of the standard with you to the course.
Those responsible for planning and scheduling an internal audit program for ISO 9001, those who must perform audits to ISO 9001, quality assurance managers, quality assurance professionals, ISO project managers and team members.