Safety Risk Management for the Pharmaceutical Industry
Instructor:
Edwin L Bills
Product ID: 700728
- Duration: 60 Min
The Pharmaceutical Industry is working to implement Safety Risk Management using ICH Q9 Guidance along with ICH Q10 Guidance on Quality Management Systems and ICH Q8 on Pharmaceutical Development. This seminar will discuss how to make Risk Management an integral part of the processes of process design and manufacturing for the industry. By planning for and reducing risk the industry will reduce time to market and reduce the cost and regulatory burden of changes in the future.
Areas Covered in the seminar:
- Defining the terminology of Risk Management.
- Integrating Safety Risk Management in the Pharmaceutical Quality Management System.
- Reducing Risk in pharmaceutical manufacturing processes.
- Including Risk Review in the complaint-handling and CAPA processes.
Who will benefit:
This program will be helpful for those who must develop Risk Management processes for Pharmaceutical companies, including:
- Manufacturing engineers
- Process engineers
- Quality engineers
- Complaint personnel
- Company clinical
- Regulatory personnel
Edwin L. Bills, was Industry Co-chair for the AAMI Committee AAMI/QM/WG 04 Application of risk management to medical devices, representing the United States on ISO TC 210 Joint Working Group 1 which developed the ISO 14971 standard. He has served as a Director of Risk Management for major medical device companies. Mr. Bills also presented at a number of conferences on Risk Management topics and has authored articles on the topic as well.
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