This webcast will aid attendees in developing a study plan for the Regulatory Affairs Certification (RAC) exams. Emphasis will be on reviewing a general study plan and adapting it to each attendee’s needs. The webcast content will be applicable to any of the RAC exams (US, EU, CAN, Global). Resource materials will be grouped by exam.
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Upon the webcast's conclusion, you should be able to:
- Describe content scope and levels of questions on the RAC exams
- Develop a personal study plan for exam preparation
- Identify tools for assessing areas of strength and weakness related to the RAC exam
- Locate and access resource materials for RAC exam study
Who Should Attend:
Those who plan to take one of the RAC exams in Spring 2012 or are considering taking the exams at a future date. The webcast also may be helpful for RAPS chapters or other communities planning an RAC study group.
Linda Temple, RAC, principal consultant, Temple Regulatory Services, LLC
Linda Temple has extensive experience in regulatory affairs, quality assurance, training and strategy, across drug, biologic and medical device products in diverse settings: industry, professional associations, and healthcare organizations. She established the regulatory intelligence and training functions in a global biotechnology company, and has led program and product development departments for two professional societies. Temple also has led IVD technical training functions and worked in clinical and research laboratories. She has published and presented extensively on regulatory affairs and related topics. Temple earned bachelor's degrees in biology and in medical technology, a master's in business administration, and an RAC(US) certification.