Negotiating the Regulatory Minefield for Multi-product Facilities ( WEBREGMINE )
Effective regulatory approval is the goal; you probably know the elements of overall planning. That is, start with your needs in mind, develop a plan, review it informally with key individuals, and consult with people who are experienced. This webinar identifies elements that should be in a specialized plan for securing regulatory approval in a multi-product facility, and helps you understand all processes involved, and how to effectively manage risk and change control in this specialized environment.
Where does your company stand with compounds of concern especially with varying regulatory attitudes around the world? The goal is to understand where the challenges are for your company, establish procedures and demonstrate that you are in control. One piece of this is to pre-empt regulatory issues through a well-designed quality risk management plan. This webinar also examines common risks, suggests concrete methods for approaching risk management in a logical and defensible manner, helps you understand the most frequent areas of regulatory concern, and how to respond to a warning letter. There is real benefit in conducting informal pre-approval discussions.
At the conclusion of this session, participants will be able to: