Event Date: 21/06/2023 10:00 - 21/06/2023 12:45
The HPRA will hold a webinar on 21 June on quality defect and recall management. The webinar will cover key topics and provide practical information regarding the reporting and investigation of quality defects. The webinar is being supported by BioPharmaChem Skillnet.
In April 2023 the HPRA updated their guide to reporting and investigation of quality defects in medicinal products for human and veterinary use. The HPRA will present the new guidance, addressing what’s new in the guide and why changes were made.
The webinar will take place as a virtual event.
Time and date
10am - 12:45pm Wednesday 21 June.
Location
The webinar will be hosted virtually.
Who should attend?
Personnel involved in quality defect reporting and investigations should attend this event.
Agenda
10:am – Susan Costello Network Director BioPharmaChem Skillnet
Introduction of topics and speakers.
10:10am – Dr. Michelle Cuffe, HPRA Quality Defects and Recall Manager
HPRA Quality Defect Reporting and Investigation Guide addressing what is new in the guideline.
10:55am – Dr. Kevin O’Donnell, Market Compliance Manager, HPRA
A look at the EU GMPs and the guidance in the Compilation of Union Procedures in this area.
11:30am – Break
11:40am – Q&A session
12:10pm – Siobhán Nolan, QDR Inspector, HPRA
Tips for companies on quality defect reporting and investigation – do’s and don’ts.
12:35 – Conclusion
Registration
To attend, please register in advance on the BioPharmaChem Skillnet registration page.
Fee details
The webinar is free to attend and there are no associated fees.