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(Online-Artikel.de) - A established Corporate Compliance Program is the baseline of a efficient regulatory management

CORPORATE COMPLIANCE PROGRAM

A established Corporate Compliance Program is the baseline of a efficient regulatory management. Preventing wrongdoing, detecting & curing misconduct and complying with regulations are the major objectives of the Corporate Compliance Program (CCP).

A CCP generates early warnings of problems, prevents whistleblower suits, may help to avoid authority inspections and reduces product liability exposure.

Elements of a successful CCP are:

• Formal commitment by board of directors
• Written standards of conduct, written policies, procedures and protocols
• Designation of corporate compliance officer and corporate compliance committee
• Regular, effective education and training programs for all affected employees
• Hotline or other reporting system to receive complaints
• Use of audits to monitor compliance and identify problem areas
• Policies to terminate violators of the program
• Develop policies for investigation of complaints and non-compliance

 
Purposes of Corporate Compliance Programs (CCP)

Prevent Wrongdoing

• Employees understand applicable laws, regulations, and company policies.
• Employees, contractors, and agents understand the importance of complying with applicable statutes and regulations.
• Design training program for employees.

Detect and Cure Misconduct

• Procedures for reporting misconduct and/or violations to appropriate person in the company
• Procedures for documenting complaints
• Procedures for investigating complaints
• Procedures for upper management to hear about and respond to violations and complaints

Comply with Regulations

• Adverse drug experiences or significant deterioration of drugs must be reported to FDA.
• Adverse event experiences with medical devices must be reported.
• Officials must be aware of investigations into complaints.
• and so on

Benefits of a Corporate Compliance Program

• Early warning to company of  problems
• Prevents whistleblower suits
• A Compliance Program may help to avoid authority Inspections
• Reduce product liability exposure

Elements of a Successful Corporate Compliance Program

1. Formal commitment by board of directors
2. Written standards of conduct, written policies, procedures and protocols
3. Designation of corporate compliance officer and corporate compliance committee
4. Regular, effective education and training programs for all affected employees
5. Hotline or other reporting system to receive complaints
6. Use of audits to monitor compliance and identify problem areas
7. Policies to terminate violators of the program
8. Develop policies for investigation of complaints and non-compliance

 
Tobias Greissel, 65719 Hofheim, Germany