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  • Regulatory and Compliance aspects of Change Control in
    Pharmaceutical Manufacturing

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Friday - Apr 25, 2014 10:00 AM
  • End Time:
  • Friday - Apr 25, 2014 11:00 AM
  • Location:
  • Online
  • This webinar will explain the role and importance of change control system in implementing an effective quality system to ensure regulatory compliance. It will also review a series of Warning Letters issued to pharmaceutical manufacturers, highlighting lapses in change control practices.

    Why Should You Attend:
    Pharmaceutical manufacturers are required by law and regulatory guidance to maintain a change control system. The interconnected nature and complexity of pharmaceutical operations demands a robust quality systems approach, and change control is responsible for ensuring changes have no unintended effect on product quality and patient health. When adequate systems are not maintained the results can be wide-ranging, from regulatory review, to halting of product/processes, to a direct effect on patient health.
    However, while regulatory guidance describes what is necessary in the quality systems equation, it doesn’t necessarily provide the direction for building a change control system, or a standardized template for the final product. Change control systems are unique to each organization, and rely on internal policies and procedures for their operation. The change control system, and the internal policies and procedures that govern it, must be crafted and maintained by experienced individuals who are not only well-versed in the regulatory guidance, but who understand how that guidance is relevant to their specific organization.
    Pharmaceutical manufacturers have a great responsibility to their regulators, their employees, and their patients to ensure that product quality and patient health are maintained at the highest achievable level. The increasingly interdependent and complex nature of pharmaceutical operations requires a strong system for reviewing, approving, and implanting change. Successful management of change begins and ends with the people participating, and their mastery of the change control fundamentals is essential
    This webinar will enhance understanding of the regulatory landscape, with regard to change control. Attendees will gain experience in the character of Warning Letter-cited lapses in change control. They will be able to think critically about common failures in Change Control, and what can be done to prevent them.
    This webinar will review a series of Warning Letters issued to pharmaceutical manufacturers, highlighting lapses in change control practices. The instructor will cover the deficiencies discovered by regulators, as well as the text of the regulations referenced. How could these companies have worked differently to avoid these actions, and how can their change processes be improved?
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