Quality Risk Management: Basic Course – ICH Q9 Guideline (R1): Theory, Tools and Applications in Pharmaceuticals
- 3-4 December 2024
- Online
-
English
- 3-4 December 2024
- Online
-
-
English
-
Training overview
Quality Risk Management: Basic Course
ICH Q9 Guideline (R1): Theory, Tools and Applications in Pharmaceuticals
The aim of this course is to provide the principles and tools necessary for the application of Quality Risk Management within the Quality Management System, from development to production and distribution of the pharmaceutical product.
The QRM process will be outlined according to the guideline ‘ICH Q9 (R1) – Quality Risk Management’ and its phases will be described in detail: Risk Assessment, Risk Control, Risk Review and Risk Communication.
The course continues with a general overview of risk assessment techniques (Fish Bone, Root Cause Analysis, FMEA/FMECA, FTA, HACCP, HAZOP, PHA and Risk Ranking and Filtering) and an outline of the areas where they are most commonly used.
Finally, the most “typical” methodologies for the pharmaceutical sector will be treated in a more analytical manner to provide participants with sufficient familiarity with the tools to face the exercise phase.
Interested in Quality & Process training?
Enroll in 3 courses and you’ll get a 15% discount*, while choosing 5 courses will grant you a 20% discount*!
Choose among these titles:
- Technology Transfer nel settore Farmaceutico – English training
- Ispezioni e Audit nel Farmaceutico
- Gestione dei risultati OOS e OOE/OOT
- Risk Analysis nel Farmaceutico
- Il Monitoraggio Ambientale nel Settore Farmaceutico
- Le Good Distribution Practices (GDP)
- La Convalida Analitica secondo ICH Q2
- Metodi Statistici per il Controllo Qualità
- APR, PQR e CAPA System
- Il Campionamento Ambito Farmaceutico
- Qualifica, Convalida di Processo e Cleaning Validation
- Inspection Readiness Documentale
- Investigational Medicinal Products: Aggiornamenti EU sugli IMPS
- La Convalida dei Metodi Microbiologici
- Studi di Stabilità nello Sviluppo Farmaceutico
- Ispezioni e Audit al Laboratorio QC Microbiologia
- RABS e Isolatori nella Produzione dei Farmaci Sterili
- Le Deviazioni Microbiologiche: Come Gestirle?
- Qualified Person: Giornate di Formazione
- Il Controllo Microbiologico nel Settore Farmaceutico
- Pharmaceutical Risk Assessment – English training
(*) discounts apply to the full prices of the courses and cannot be combined with other promotions.
The promotion is limited to enrolling the same person in 3 or 5 courses selected from those offered.
Key points of the training
- Understand the requirements of Quality Risk Management
- Understand in detail the steps of the Quality Risk Management process
- Know the main Risk Assessment techniques and their application
- Identify the most appropriate Risk Analysis tools for each scenario
Training structure
Times are UTC +1 (Rome time)
9:00 am – 1:00 pm SESSION DAY 1
9:00 am – 12:00 am SESSION DAY 2
Program
- Regulatory Framework
- ICH Q9 (R1) Guideline – Quality Risk Management
- Overview of the QRM tools:
Fish Bone
Root Cause Analysis
FMEA/FMECA
FTA
HACCP
HAZOP
PHA
Risk Ranking and Filtering - Examples of Tools applications with presentation of case studies:
ICH Q3D Risk Assessment
Nitrosammine Risk Assessment
Supplier Risk Assessment
Cleaning Validation Risk Assessment
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.
Cancellation terms
In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
Participant replacement
It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. 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.
Training cancellation
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.
Speakers
Daniele Calzolari
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.
Register now
800€
Training materials available for attendees
Certificate of attendance
Senior trainers with hands-on experience
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