QUALITY ASSURANCE AND CONTROLS

Evaluating written procedures and standard operating procedures
Helping to interpret regulations in concert with industry standards
Developing laboratory quality, analytical methods, methods validations, and product component specifications
Creating a program to meet current FDA expectations for Compliance
Consulting self-evaluations
Building sampling plans

Performing trend analysis
Providing corporate oversight programs and enhancement—including good governance practices; corporate quality/compliance functions and oversight practices; and independent advice to CEOs, senior managers, and board members
Implementing site oversight programs, including internal audits and performance metrics
Reviewing and enhancing management controls
Reviewing and enhancing organizational structures—including functions, reporting relationships, responsibilities, staffing and competence; communication systems and performance (vertical and horizontal); and independence, staffing, and competence of quality units