Participants will gain an understanding of quality by design as it applies to pharmaceutical product development, approval and manufacturing. The course is broad in scope covering the evolution of the regulatory environment- where it was, the current environment and future trends. The programme will cover new quality system design approach to new drug development and the drug approval process. The course will help participants develop an understanding of quality risk management based on ICH Q9 and learn about RiskMAP’s.

If you have any questions, comments, or suggestions, you may contact IPA at:

Tel: 905-940-8886
enquiry@ipacanada.com

This seminar is recommended for staff members involved in preparing plans, procedures, and instructions as part of a documented management system, especially valuable for those responsible for document maintenance and improvement, including management representatives and auditors, quality managers, operations managers, purchasing and process monitoring control staff.