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

28/29 October 2020

Course No. 17694

header-image

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

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

Seminar Programme as PDF

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

stop

This course is part of the GMP Certification Programme "ECA Certified API Production Manager" Learn more

This training/webinar cannot be booked. Send us your inquiry by using the following contact form.

To find alternative dates for this training/webinar or similar events please see the complete list of all events.

For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.

* also payable by credit card
American Express Visa Mastercard

icon
Further dates on-site
Further dates on-site
Not available
icon
Further dates online
Further dates online
Not available
icon
Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"The lectures were very informative, interesting and entertaining."

Albert Godoy Hernández, Company synaffix
Live Online Training - GMP Auditor Practice, October 2024

"Really useful training which I will use in my daily work."

Regina Mommaerts, Galapagos NV
Live Online Training - GMP Auditor Practice, October 2024

"Wonderful format of the sessions: Good range of participations and experience in the team. Would love to attend another one soon."

Roopasi Mathi, Wacker Biotech B.V.
Live Online Training - GMP Auditor Practice, October 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023