Building upon Overview of FDA and Quality Systems Overview courses, this course goes beyond the basics and uses interactive exercises to understand and apply current Good Manufacturing Practice (cGMP) regulations for pharmaceutical, biopharmaceutical and medical device industries. This course will dive into the details of 21 CFR Parts 210, 211, & 820, ICHQ7, and the EU GMP guidelines. Participants will benefit from real world examples and lessons learned to use risk-based and scientific principles to ensure product quality throughout the production lifecycle. This course will guide participants through the six system inspection model: Quality Systems, Materials, Packaging and Labeling, Production, Facilities & Equipment, and Laboratory Controls, to provide them with appropriate strategies for ensuring compliance.

To successfully implement and maintain a quality management system a company must have an Internal Audit process and use trained auditors to perform the audits. Internal auditors are also a key element in quality system improvement. This new course teaches auditing to the ISO 13485:2016 standard and places a strong emphasis on promoting employee participation in the improvement process.

Data integrity and good documentation practices (GDP) are essential in providing evidence of a safe and effective product. Learn what the key elements of good documentation practices and data integrity are, how to apply them, and how to proactively ensure your system is compliant.

Two key goals of a quality management system are to find the root causes of actual and/or potential problems in order to develop and implement permanent solutions that are accepted, efficient, and effective. This 1-day workshop will show how to use root cause analysis tools and methods to find the underlying causes of problems that impact an organizations operations and profitability. You will also learn the methodology to address corrective actions. This workshop is perfect for the novice or for those desiring an invigorating refresher.