Environmental, Health & Safety (EHS) Issues in the Pharmaceutical and Medical Device Industries

This two-day course is designed for environmental, health and safety (EHS) professionals who participate in day-to-day compliance decision making. In addition, product/process engineers, quality assurance professionals (especially those responsible for implementation of management systems) and individuals in management who interact with EHS regulatory agency inspectors to rationalize or defend EHS compliance programs will benefit from this class.

Consultants and facilities engineers will find this course useful for enhancing their knowledge of EHS compliance. For those new to managing and reporting on EHS compliance issues, this course will cover the topics required for optimal job performance. Seasoned veterans in the world of EHS will find this to be an excellent refresher course.

Learning Objectives

Attendees will:

-Obtain an understanding of EHS law and compliance
-Learn practical compliance strategies to enhance a company’s bottom line
-Learn to leverage management systems to simplify complex regulatory requirements in the area of pharmaceutical, biomedical and EHS
-Develop the ability to deliver compliance and improvement strategies to management and obtain approval
-Learn to evaluate upcoming trends and requirements in EHS such as global warming, energy conservation, banned substance initiatives, FIN 47, sustainability, etc and their potential impact to the industry

Course Description

Environmental health and safety regulations continue to evolve and become more complex. Regulatory changes have been designed to improve the condition of the environment, as well as, better the conditions under which workers execute their tasks. This course is designed to review EHS regulations applicable to the pharmaceutical, biotech and medical device industries.

EHS programs include directed compliance with EHS regulations in addition to customer and shareholder initiatives that address the concerns of those parties with respect to environmental, health and safety issues throughout the product life cycle. Design for environment and safety includes introducing EHS issues into the product development process so that these issues may be addressed proactively as product concepts are developed. Since reducing a product’s time to market is important in today’s business arena, early integration of EHS into the product life cycle can save time and cost.

In addition, this course will compare and evaluate synergies between compliance with QSIT and ISO13485 guidance and requirements with EHS management systems. The complex elements of these systems will be simplified into usable approaches that companies are successfully applying today. The course will focus on how to integrate EHS into existing management systems, as well as, enhancing strategic implementation without compromising compliance.

This course was created to help organizations implement EHS programs and initiatives early in a product life cycle to proactively address and mitigate downstream EHS issues and compliance obligations.