INTRODUCTION TO REGULATORY PRACTICE

ABT 740

Identifies and examines the key regulatory agencies and practices that govern the highly regulated and diverse biotechnology industry, both domestically and internationally. Highlights current and emerging FDA and ICH regulations and guidance documents to successfully navigate meeting with the agencies and to submit required documentation for successful product development.

PHMSCI 752

The pharmaceutical and biopharmaceutical industries have strict documentation and production requirements. Prepares the learner to work in a regulated environment. Explains roles and responsibilities across multiple disciplines and proper documentation practices. Prepares learner for protocol, report creation and audit responses. Discusses specifications, guidances and root-cause analysis.

PHMSCI 759

Provides the experience and skill to find, read and critically analyze scientific and regulatory literature in the field of drug discovery and development.

BIOMDSCI 721

Quality Assurance and Regulatory Affairs departments influence and facilitate successful product development within the biotechnology industry. Use a case study approach to explore and apply how quality assurance and regulatory compliance systems are used to bring medical devices to market. Practice how cross functional teams work together to meet regulatory standards of safety.

PHMSCI 754

Explores the process of bringing pharmaceutical products to market, particularly as it applies to the scaling up, manufacturing, and maintenance phases that come after FDA approval of a product is obtained. Identifies various factors that impact the life cycle management of pharmaceutical products from development to sustained large-scale distribution, such as: target product profile (TPP), chemistry, manufacturing and controls (CMC), active pharmaceutical ingredient (API) supply chain considerations, raw materials shortages, demand planning/forecasting, and post-approval regulatory considerations.