ICH Q9 (R1): What has changed? From current requirements to implementation in the Quality Management System

  • 2° EDITION: 13 March 2024
  • Online
  • Italian

Training overview

The training course “ICH Q9 (R1): what has changed?” focuses on the change in regulatory requirements for the Pharmaceutical industry originating from the recent revision of the “ICH Q9 – Quality Risk Management” guideline. Participants will be presented with the rationale and motivations that made it necessary to revise the ICH Q9 guideline, and will be given a review of all areas for improvement. A detailed comparison between the old edition and the current version will follow, going chapter by chapter to analyze all the changes that have been incorporated. All these changes made to the ICH Q9 guideline will impact the company’s Quality Management System in various ways, which we will be able to examine during this course. Finally, practical examples will be shown on what is meant by an appropriate risk assessment model in accordance with the new ICH Q9 guideline.

Key points of the training

  • Understand the reasons that led to the revision of ICH guideline Q9 - Quality Risk Management
  • Know in detail all the changes made in the ICH Q9 revision (R1)
  • Understand the impact of the ICH Q9 (R1) revision on the company's Quality Management System

09:00 – 13:00 MORNING SESSION

  • Regulatory framework
  • Why the revision of the ICH Q9 (areas of concern) was necessary
  • Deliverables of the ICH Q9 revision
  • Overview of comments received from trade organizations and pharmaceutical industries
  • ICH Q9 versus ICH Q9 (R1)
  • Impacts of the audit on the Quality Management System of the pharmaceutical company
  • Case studies – Dos&Donts
  • Final considerations

The course was designed 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

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.

Sara Cretella

Sara Cretella

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

She is graduated in Chemistry at the University of Florence. Sara immediately began her work at Pharma D&S, where, over the years she has carried out various activities: support to companies in drafting 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, her main activity, in the development of Quality Risk methodologies Management concerning process validations, 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
400€
450€
Early Bird 5%
Within 1 month before the start of the training
425€
450€
Full price

450€

Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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