Category: OIG Compliance Program Guidance for Pharmaceutical Manufacturers

II. Compliance Program Elements D. Conducting Effective Training and Education

The proper education and training of officers, directors, employees, contractors, and agents, and periodic retraining of personnel at all levels are critical elements of an...

II. Compliance Program Elements C. Designation of a Compliance Officer and a Compliance Committee

1. Compliance Officer Every pharmaceutical manufacturer should designate a compliance officer to serve as the focal point for compliance activities.12 This responsibility may be the individual’s...

II. Compliance Program Elements B. Written Policies and Procedures (Page 1)

In developing a compliance program, every pharmaceutical manufacturer should develop and distribute written compliance standards, procedures, and practices that guide the company and the conduct...

II. Compliance Program Elements A. The Basic Compliance Elements

The OIG believes that every effective compliance program must begin with a formal commitment by the pharmaceutical manufacturer’s board of directors or other governing body....

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