GMP & GDP Forum 2023

 

Moderator
Lance Smallshaw

 

Part D – Inspection Trends

Hybrid Inspections
Thomas Højsholm Schmidt

• Definition of hybrid audits/inspections
• Planning for hybrid audits/inspections
• Conduct of hybrid audits/inspections

MHRA Audit – A System also for the EU?
Dr Afshin Hosseiny

• What is MHRA Audit?
• Experiences with MHRA Audit?
• A system also for the EU?

SESSION 3: Parallel Sessions & Workshops with Inspectors

Moderators
Ralf Gengenbach | Dr Rainer Gnibl | Dr Thomas Schneppe |
Dr Wolfgang Schumacher | Ib Alstrup | Saddam Huq | Alfred Hunt

Get involved in the ECA Interest and Working Groups. Each delegate will be invited to discuss the upcoming developments with the Chairs/members of the working groups and EU inspectors.

You can address topics of interest and you can provide feedback on the currently planned activities. It is the aim of the Working Groups to provide a platform for discussion with both colleagues from industry and regulatory authorities.

Option 1 (Validation Group):

Qualification & Validation: Metrics in Validation/Commissioning and Qualification
Ralf Gengenbach | Dr Thomas Schneppe | Dr Rainer Gnibl

This interactive session will offer the opportunity for the participants to discuss some of the newer developments in qualification and validation activities:

• How to calculate cp/cpk, pp/ppk
• How to interprete cp/cpk, pp/ppk
• How can qualification and GEP interact?
• How can suppliers be implemented?

 

Option 2 (Data Integrity Group):

Annex 11 changes
Dr Wolfgang Schumacher | Ib Alstrup

This interactive session will offer the opportunity for the participants to discuss current Data Integrity issues.

• What will change?

Option 3 (GDP Group):

Mean Kinetic Temperature (MKT)
Saddam Huq

This workshop will offer the opportunity to discuss the following aspects:

• What is MKT and Conditions and Rules when MKT could be applied

 

Option 4 (GDP Group):

Deviation Management
Alfred Hunt

During this workshop participants will learn and discuss how to ensure that the deviation system is being correctly used and implemented.

• Effective Root Cause Analysis
• Extending Impact Assessments
• CAPAs that work
• Example of deviations which will be worked on by the attendees

Part E – Regulatory Trends

FDA´s Quality Metrics Initiative – Current Status and what industry can already use to supervise and improve Qualty of products
Dr Frank Seibel

• Regulatory Requirements
• Implementation into Pharmaceutical Quality Systems
• Meaningful working with metrics

Managing Medicines Shortages: Reducing the Impact on the Pharmaceutical Supply Chain
Dr Uwe Rettig

• Lesson learned after pandemic and other crises impacting global supply chain, e.g. looking at insecure markets, raw material / energy supply, uncertain customers/distributers or unreliable suppliers and the effects on the pharma supply chain
• Analysing the collaboration between all supply chain stakeholders
• Challenges, solutions, best practice and forecast for functioning supply chain for advanced therapy manufacturing