Event Date: 27/09/2012 01:00
The Compliance Department hosted two Information Days this year at the Crowne Plaza Hotel in Santry. The GMP and Market Compliance Information Day on 27th September and the Wholesale Distribution Information Day on 28th September.
Aims of the Seminar
These events were aimed primarily at manufacturers of medicinal products, manufacturers of active substances and distributors of medicinal products.
Who Should Attend
This event is now closed. Please contact compliance.infoday@hpra.ie if you require further information.
Fee & Venue Details
The venue for these events was the Crowne Plaza Hotel, Northwood Park, Santry Demesne, Dublin 9.
Fees:
GMP and Market Compliance Information Day €250
Wholesale Distribution Information Day €250
Attendance at BOTH Information Days €400
IMB Cancellation Policy
In the event of cancellation half of the fee will be refunded in all circumstances.
Presentations: GMP and Market Compliance Information Day
0. GMP and Market Compliance Information Day Agenda 2012
1. Regulatory Update
2. ICH Q10 Quality Management Considerations
3.1 Falsified Medicines v.2
3.1.1 Compilation of Community Procedures - API Registration Form
3.2 Starting materials - changes from FMD
4.1 Improving Quality Risk Management activities to better support GMP Activities
4.1.1 Bibliography
5.1 Cleaning Validation - Assessing residues
5.2 Cleaning Validation - Facility & Equipment Consideration & Potent Materials
5.3 Cleaning Validation the Toxicological Approach
6.1 Quality Defects - Recent Trends
6.2 Update to IMB Guidance Note on Defect Reporting
6.3 Regulatory Compliance Inspections at MAH Offices
7.1 Rapid Microbiological Methods
7.2 Common Deficiencies
7.3 Environmental Monitoring Program
7.4 Aseptic Process Validation
7.5 Steam in Place (SIP)
7.6 Application of Annex 1 to manufacture of a Biological Drug Substance
8.1 Objectives and impact of the draft revision of the EMA PV guidance
8.2 Current GMP guidance & revision of Annex 15
8.3 Process Validation Deficiencies
Presentations: Wholesale Distribution Information Day
0. Wholesale Distribution Information Day Agenda 2012
1.1 Falsified Medicines Directive - Impacts for Wholesalers
1.2 Revision of the EU GDP's and Implications for Wholesalers
1.3 Wholesale Distribution and Continuity of Supply
2.1 Computerised Systems
2.2 Maintaining Compliance with Regulatory Requirements for Outsourced Activities
2.3 Quality Risk Management Exercise
2.3.1 KOD GDP QRM Case Study 2012
2.3.2 KOD Notes on GDP QRM Case Study 2012
3.1 Importance of Product Classification
3.2 Practical Guide to THMP's
3.3 Product Classification - Borderlines
4.2 Falsified Medicines Case Studies_Impacts FMD & GDPs