ISO: 14971 Risk Management – One day Course - Virtual Classroom
Oct 5and 12 2020
ICH Q9 QRM - Quality Risk Management
The importance of quality systems has finally been recognized in the pharmaceutical industry and it is becoming evident that quality risk management is a valuable component of an effective quality system.
It is now an Expectation of Regulators that a Risk Management Process is clearly defined and utilised for the full product lifecycle.
Pharmaceuticals stakeholders (including patients and medical practitioners as well as government and industry) must protect the patient by managing the risk to quality. Iproduct quality should be maintained throughout the product lifecycle such that the attributes that are important to the quality of the drug (medicinal) product remain consistent with those used in the clinical studies. An effective quality risk management approach can further ensure the high quality of the drug (medicinal) product to the patient by providing a proactive means to identify and control potential quality issues during development and manufacturing.
Effective quality risk management can facilitate better and more informed decisions, can provide regulators with greater assurance of a company’s ability to deal with potential risks and can beneficially affect the extent and level of direct regulatory oversight.
Course Objectives (Summary)
Describe the purpose of Quality Risk Management and explain the Risk Management Process elements.
Explain the purpose, content and interrelationship of ICH Q9 and ICH Q10.
Interpret requirements of ICH Q9.
Define risk management.
Describe most frequently used risk assessment tools.
Define basic risk management terms.
Identify risk management responsibilities.
Describe the benefits of risk management.
During the one day training participants will acquire knowledge and skills to implement an effective Quality Risk Management system in conformance to ICH Q9. Quality Risk Management, similar to any other system, evolves over time within a company as Knowledge grows and frequent reviews are conducted. Hence, the best place to practice and extend your experience is in reviewing one’s current system, conduct a gap analysis and determine if current established requirements are sufficient to meet applicable regulatory requirements.
Delivered by Pharma/Biopharma Experts
Who should attend
All personnel involved in areas relating to Quality, Regulatory, Production, Engineering, Supplier and Outsourced Process Management should be conversant with these requirements to provide assurance of Competency in Quality Risk Management.
This intensive course will evaluate and focus on the requirements of the ICH Q9 in detail and will demonstrate Quality Risk Management practices that reflect best in class practices.
Need a quote for in-house training email email@example.com or phone +353 (0) 1-204 0646
Places cancelled within 10 working days of commencement must be paid in full. Substitutions may be made at any time at no additional charge.
As places are limited, book early to avoid disappointment.