ComplianceOnline

This 90-minute webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing.

This webinar will help you understand the process, requirements, quality and safety considerations for demonstrating biosimilarity to a Reference Product.

This 90-minute webinar will cover the different aspects of formulating and stabilizing bimolecular formulations. It will provide valuable assistance to personnel involved in the development and manufacture of liquid and lyophilized proteins.

This webinar will provide you with an overview of risk factors in clinical trials and discuss possible ways to mitigate, control, assess impact, and prevent them in your trial.

This Project Management training for Auditors will help you understand how to apply project management principles to auditing to ensure efficient and effective quality assurance of drug development.

This webinar will cover the basics of process validation for pharmaceutical products and give you a strong understanding of what is involved. It will provide beginners an understanding of the validation master plan.

This webinar on Risk Evaluation and Mitigation Strategy (REMS) will help you understand how to adhere to REMS policy, its implementation and submission requirements.

This 2-hr webinar will review the FDA and FTC regulations for promoting and advertising dietary supplements, walk you through real-life case studies, help you address compliance, and tell you how to respond to an FDA enforcement action.

This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures.

This 90-minute webinar on sampling plans using ANSI/ASQ Z1.9 will explain the methods in Z1.9 and shows how to use it in a more modern setting (using simple statistical calculators).