The introduction in recent years of the concept of Quality Risk Management inside GMP guidelines has caused a change in the regulatory requirements for the pharmaceutical industry. Starting from the analysis of these important changes and the “ICH Q9 – Quality Risk Management” guideline, aim of the training “Pharmaceutical Risk Assessment: techniques and applications” will be to illustrate to the attendees the process of Quality Risk Management and all its phases: Risk Assessment, Risk Control, Risk Review and Risk Communication. The most widely used Risk Assessment techniques (Fishbone, Root Cause Analysis, FMEA, FTA, Risk Ranking and Filtering) will be examined and framed in the contexts in which they are most commonly applied. Emphasis will be put on making the attendee sufficiently familiar with these tools to help him tackle real life situations. To this end, the expert will showcase some case studies to better underline how to correctly put theory in practice.
Key points of the training
- Understand how the application of Quality Risk Management has changed the regulatory requirements
- Learn in detail all the steps that make up the Quality Risk Management process
- Understand the main Risk Analysis Tools for an effective application in your own business reality
- Identify the most appropriate Risk Analysis tools for each scenario
- Learn which Risk Assessment models have been most applied to address regulatory requirements
Times are UTC +1 (Rome time)
9:00 am – 1:00 pm SESSION DAY 1
9:00 am – 12:00 am SESSION DAY 2
- QRM – GMP Update and Pharmaceutical Quality System
- ICH Q9 – Quality Risk management
- Overview of the main Risk Assessment Tools and focus on Fish Bone, Root Cause Analysis, FMEA, FTA and Risk Ranking and Filtering
- Examples of application of the tools with presentation of case studies:
– Risk Assessment approach ICH Q3D (Elemental Impurities in drug products)
– Nitrosamines Risk Assessment
- Supplier Risk Assessment (to determine audit frequency)
- Application of QRM in Cleaning Validation: definition of Cleaning Plan, Worst case product and calculation of limits
Quality Assurance, Validation Team, Production, Quality Control, Engineering.
The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.
For online trainings the access link will be sent 2-3 days before the start of the training.
5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.
In order to cancel enrolment to an event, please email firstname.lastname@example.org within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
It is possible to replace a participant attendance without additional cost, simply by contacting email@example.com. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.
If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.
Quality & Process - Team Leader Senior Consultant at Pharma D&S
He graduated in Chemistry of Biological Molecules at the University of Florence in 2016. Calzolari immediately started his career at Pharma D&S, where, over the years he has carried out various activities: support to companies in drafting of GMP documentation (SOP, PQR, OQ/PQ report), in the preparation of inspections (gap analysis), in the execution of audits to its suppliers, in the execution of Training on GMP Quality Systems and, its main activity, in development of Quality Risk Management methodologies concerning process validation, Cleaning Validation, Cross-Contamination, control of elemental impurities (ICH Q3D), control of the presence of Nitrosamines in APIs and pharmaceutical products.
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