Inactive

Online Executive Development Training RFQ No. FDA-20-SOL-1224312 In January 2015, FDA established the CDER Office of Pharmaceutical Quality (OPQ) as a new super-office dedicated to pharmaceutical qual... Online Executive Development Training RFQ No. FDA-20-SOL-1224312 In January 2015, FDA established the CDER Office of Pharmaceutical Quality (OPQ) as a new super-office dedicated to pharmaceutical quality across all manufacturing facilities and product areas. CDER established the new office through re-aligning functions and personnel from other CDER offices to centralize regulatory review, policy, research, and science activities, project management, quality management systems, and administrative activities. Since January 2015, OPQ has become a fully functioning super-office. However, OPQ continues to face numerous challenges to provide online high-quality training to staff—in addition to increasing pressure to expedite processes. To address these issues and set the course for key areas of focus for the future, OPQ leadership began efforts to develop a Strategic Plan—with the intent to address these challenges. One challenge identified is current and future staffing training needs. Highly trained staff is directly related to OPQ’s ability to be prepared for a mandated shortening of the drug review process from 15 months to 10 months, and congressionally mandated Generic Drug User Fee Amendments (GDUFA), Biosimilar User Fee Amendments (BsUFA) and Prescription Drug User Fee Act (PDUFA) requirements. OPQ must take measures to ensure that all sub-offices have the necessary highly trained staff required to meet these requirements in regulatory and leadership training. OPQ anticipates providing its staff with access to the following 3-week and 6-week business school programs: Leading Strategic Growth (6-week program) Implementing Winning Strategies (3-week program) Building & Leading Effective Teams (3-week program) Leading Innovative Change (6-week program) Accelerating Change Readiness & Agility (3-week program) Leading Operational Excellence (6-week program) Leading & Managing Globally (6-week program) Leading Through Financial Excellence (6-week program) Fostering Inclusion & Diversity (3-week program) Leading Customer-Centric Growth (6-week program) Leading Effective Decision-Making (6-week program) Selling Through Customer Centricity (3-week program) Leading with Data & Analytics (6-week program) Driving Digital Transformation (3-week program) All questions/clarifications must be submitted by 10:00 PM Eastern Time on July 16, 2020. Questions submitted after the due date may not be answered