Regulatory and Compliance aspects of Change Control in Pharmaceutical Manufacturing

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?

Areas Covered in the Webinar:

• Overview of Change Control
  • Regulatory landscape
  • cGMPs, ICH, guidance documents
  • Internal/corporate quality
  • What types of change require a formal change control?
• Review a Series of Warning Letters, Highlighting Failures in the Change Process
  • What went wrong?
  • What are the referenced regulations?
    • Review the regulations, to better understand the character/intent of the rule
  • What should the manufacturer have done?
    • How would a robust change procedure be different?
• The Importance of The Change Control Process in Continuous Improvement
  • The role of change control in resolution of non-conformance/deviations and the CAPA process
• Summary
  • What types of themes are we seeing?
  • What can be done to remediate/prevent these lapses?
  • What are common barriers to successful management of the change control process?

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in Pharmaceutical companies operating/manufacturing under GxP guidelines and third party groups/contract organizations serving the world of pharmaceutical manufacturing. The following personnel will benefit from this webinar:

• Pharmaceutical Professional involved in the manufacture of products
• API and Excipients Providers
• Service Providers
• All Levels of Management
• Change Control Professionals
• Quality Professionals

Instructor Profile:

Bradford Booth, is a certified specialist microbiologist, business analyst, and experienced biotech and pharma industry professional. He has held roles in Quality Systems, manufacturing Quality Assurance, Quality Control laboratories, and Compliance.

He has worked internationally in sterile injectables (egg-based vaccines), has hands-on knowledge of sterile product bioreactor (E.coli and mammalian), CHO cell / roller bottle therapeutic protein bioprocessing, and solid dose pharmaceutical manufacturing. He has also conducted academic research in cell and molecular biology, including cloning, expression, purification, and analysis of recombinant proteins.