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Welcome to the world of quality risk management or QRM! As we all know, identifying, assessing, and mitigating risks is crucial during the production and distribution of medications. And that’s where QRM comes into play. The industry standard, ICHQ9, has been around since November 2005, and the most recent revision, ICHQ9(R1), has just been adopted to correct any deficiencies in the original text.
An effective QRM process lists all potential risks associated with the evaluated product or manufacturing process, utilizing science-based decision-making. A procedure or SOP is typically in place to outline how risk assessments are determined, including the level of formality and type of assessment to be used.
The QRM process involves making decisions based on the risk’s probability, seriousness, and detectability. Risk analysis/assessment tools identify and assess hazards, while risk control is used to minimize or manage risk to acceptable levels.
In this exclusive webinar, we will explore several situations where QRM can be used prospectively and retrospectively. We’ll delve into examples of retrospective risk management, such as deviation scenarios, where we need to assess the risks associated with releasing a batch in question and other batches of similar material previously supplied to the market. We’ll also look at prospective risk analysis, using examples of introducing new processes or major pieces of equipment and using QRM to generate process and equipment FMEAs to document all potential failure modes systematically.
Finally, we’ll examine periodic or ongoing risk management activities such as periodic vendor reviews. Join us on the 18th of July, and we will equip you with the tools and scenarios necessary to utilize the principles of QRM within your pharmaceutical operations to minimize risk and maximize success. Don’t miss out! Register now.
Who Should Attend:
- Quality Managers, Head of Quality, Quality Director, Risk Management Specialist and Supplier Quality Managers
- Skill Level: Intermediate , Expert
16:00 – 16:10 Introductions
16:10 – 16:20 The theory of QRM & history of ICHQ9
16:20 – 16:30 Prospective Risk Management – The process or equipment FMEA
16:30 – 17:40 Retrospective Risk Management – The HHE or Product Risk assessment
17:40 – 17:55 Ongoing/Periodic Risk Review – Vendor Risk Management and Risk registers
17:55 – 18:10 Summary and questions
Special event information:
- All participants will get a complimentary certificate of attendance courtesy of the webinar's sponsor - Qualio.
Charley MaxwellManaging Director & Consultant QP / RP
Charley is the owner and Managing Director of Orion GXP Consulting. He has over 20 years of experience working in manufacturing QA, regulatory compliance, batch release, and distribution in the pharmaceutical and medical device industry. He has assisted multiple clients with designing, developing, and implementing phase-appropriate Quality Management Systems, vendor management, audit programs, quality risk management, and training. Charley has a Bachelor’s of Science In Biochemistry and a Master’s In Pharmaceutical Manufacturing Technology. He has acted as a QP in Ireland for sterile and non-sterile manufacture, clinical IMP release, and third-country Importation.
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