Live Online Conference: 23rd APIC/CEFIC Global GMP & Regulatory API Conference 2020 - GMP Part

Wednesday, 28 October 2020 10.00 - 17.20 h

Course No 17694

Our Service

Costs

This training/webinar cannot be booked. To find alternative dates for this training/webinar or similar events please see the events list by topic.

For many training courses and webinars, there are also recordings you can order and watch any time. You can find these recordings in a list sorted by topic.

Or simply send us your inquiry by using the following contact form.

Send request

* also payable by credit card

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Hélène Bruguera, EDQM France
Marieke van Dalen, Aspen Oss B.V., The Netherlands
Katherine Eban
Stephan Heck, Catalent Pharma Solutions, Germany
Dr Sau (Larry) Lee, US FDA, USA
George Hartong van Lokven, Aspen Oss B.V., The Netherlands
Nuno Matos, Hovione, USA
Beate Miller, DSM Nutritional Products, Switzerland
Frank Montgomery, AstraZeneca
Ibrahim H. Mujammami, SFDA, Saudi Arabia (invited)
Jeong-Ja Oh, Synex Consulting, South Korea
Cathal O’Duinn, Janssen Pharmaceuticals, Ireland
Rosimeire Pereira Alves da Cruz, ANVISA, Brazil
Fabio Polato, Sandoz, Austria
Florent Trouillet, Siegfried, Switzerland
Dieter Vanderlinden, Ajinomoto Bio-Pharma Services, Belgium
Stefaan van de Velde, Ajinomoto Bio-Pharma Services, Belgium

Objectives

The APIC/CEFIC Global GMP & Regulatory API Conference is Europe’s leading API event. Many major stakeholders from Authorities and the Industry are joining this Conference each year. Speakers from EMA, EDQM, FDA, National Authorities, the Industry and Industry Associations will discuss the latest developments in the field of GMP and Regulatory Compliance.

The GMP part of the Conference, of which the final module is a Joint GMP & RA session, provides updates from recent authorities’ initiatives, activities and interpretations related to GMP compliance of API manufacturing. Hear from industry speakers about their approaches and best practices on compliance related to the various existing and emerging aspects of API GMP.

The Parallel Sessions are no workshops. They are practically oriented and supposed to be highly interactive.

Programme

GMP part

Development and application of Mutual Recognition Agreements
Speaker to be named by EMA

Proactive application of operational excellence in the external supply chain
Cathal O’Duinn, Janssen Pharmaceuticals

Framework for deployong operational excellence
Data driven approach to risk identification
Proactived deployment and sustainability

Life Cycle approach to process validation
Stefaan van de Velde, Ajinomoto Bio-Pharma Services

How science and risk based logic can help continuously improving processes
Practical approach

ANVISA’s view on inspections
Rosimeire Pereira Alves da Cruz, ANVISA

Status and Review of current inspection activities
Top 10 Findings from ANVISA’s inspections
Outlook on future inspection program

Risk based approach to supplier management
Dieter Vanderlinden, Ajinomoto Bio-Pharma Services

Regulatory requirements and expectations
Industry best practices - how to manage suppliers?
Elements to consider to support risk based approach

Fraud in generic pharmaceutical manufacture: A worldwide life-threatening danger
Katherine Eban

The various forms of fraud
How inspectors are being fooled
How do APIs fit in?
Are we solving the problems?

Parallel Sessions

Quality culture
Stephan Heck, Catalent Pharma Solutions

What is quality culture?
Why is the quality culture of an organisation important to APIs and patients?
How is the quality culture of an organisation developed?
How can you assess an organisation quality culture?

Specifics for Sterile APIs
Fabio Polato, Sandoz

Sterile API production – Annex 1 GMP
Regulatory consequences
The relationship with the customers

ICH Q13 – Continuous Manufacturing of Drug Substances and Drug Products
Nuno Matos, Hovione

ICH Q13 purpose
Continuous Manufacturing process benefits for Industry
Guideline status and next steps

API registration in Brazil: an overview
George Hartong van Lokven, Aspen Oss B.V.

Brazil specifics
Registration procedures: past, present and future

Cleaning in multipurpose facilities
Florent Trouillet, Siegfried (Evionnaz)

Health authorities’ requirements and cleaning challenges for multipurpose facilities
Criteria for risk analyses to develop cleaning methods and cleaning validation strategy in a multipurpose facility
Risk-based approach for limit setting on intermediates and early development products
Practical examples

APIC´s Experience with API Registrations in China
Beate Miller, DSM Nutritional Products

The Regulatory Framework in China
Chinese DMF Requirements
Experience of APIC Members & Case Studies

Joint GMP And Regulatory Affairs part

Update from EDQM
Hélène Bruguera, EDQM

Latest news on the certification scheme
The EDQM inspection programme

Latest developments in nitrosamine impurities – impact to the API industry
Speaker to be announced, Member of the APIC Task Force on Nitrosamines

Why are nitrosamines a concern?
What is expected from the API Industry from a GMP and regulatory perspective?
Interactions between API Industry and marketing authorisation holders

ICH Q12 - Now the hard work starts in implementation
Frank Montgomery, AstraZeneca

How to define ECs and where in the CMC should they be listed
PACMP – advantages and how to use
PLCMP – advantages and how to use

Innovation and continuous manufacturing
Dr Sau (Larry) Lee, FDA

FDA’s efforts to modernize drug manufacturing
Guidance for Industry: Quality Considerations for Continuous Manufacturing
Batch vs. continuous manufacturing
FDA’s Emerging Technology Program

Go back