Quality Risk Management: Fundamental Training – ICH Q9 (R1) Guideline: Theory, Tools, and Applications in the Pharmaceutical Industry

  • 1° EDITION: 17 October 2024
  • 2° EDITION: 11 March 2025
  • Online
  • Italian

Training overview

Quality Risk Management: Fundamental Training
ICH Q9 (R1) Guideline: Theory, Tools, and Applications in the Pharmaceutical Industry

The training course will introduce the change in regulatory requirements for the pharmaceutical industry started by the application of Quality Risk Management through the changes introduced in recent years at a GMP level.
The QRM process will then be outlined in accordance with the “ICH Q9 – Quality Risk Management” guideline, detailing the stages that constitute it: Risk Assessment, Risk Control, Risk Review and Risk Communication.
The lecturer will move on to a general overview of Risk Assessment techniques (Fish Bone, Root Cause Analysis, FMEA, FTA, Risk Ranking and Filtering) and framing of the areas where they are most used, then the most adopted methodologies in the pharmaceutical sector will be addressed in a more analytical way, in order to hand over to the participants sufficient familiarity with these tools.
The training will also present examples of interesting Risk Assessment models applied to the pharmaceutical sector.

Key points of the training

  • Understand the regulatory requirements originating from the application of Quality Risk Management
  • Know in detail all the steps that make up the Quality Risk Management process
  • Understand the main Risk Analysis Tools for effective application in their own business reality
  • Identify which risk analysis tools are most appropriate for the issues under consideration
  • Know the main Risk Assessment models applied to the regulatory requirements introduced in recent years at the GMP level

09:00 – 13:00 Morning Session
14:00 – 17:00 Afternoon Session

Program

  • Regulatory Framework
  • ICH Q9 (R1) Guidelines – Quality Risk Management
  • Overview of main QRM Tools:
    • Fish Bone
    • Root Cause Analysis
    • FMEA/FMECA
    • FTA
    • HACCP
    • HAZOP
    • PHA
    • Risk Ranking and Filtering
  • Exemples of Tools Application with Case Studies:
    • ICH Q3D Risk Assessment
    • Nitrosammine Risk Assessment
    • Supplier Risk Assessment
    • Cleaning Validation Risk Assessment

The course isdesigned for personnel involved in the following areas: 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

Daniele Calzolari

Quality & Process - Team Leader Senior Consultant at Pharma D&S

Graduated in Chemistry of Biological Molecules at the University of Florence in 2016, Dr. 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

Early Bird 10%
Within 2 months before the start of the training
760€
850€
Early Bird 5%
Within 1 month before the start of the training
800€
850€
Full price

850€

Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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