Japan Quality - Live Online Training

Japan Quality - Live Online Training

Course No 19478

All times mentioned are CEST.

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.

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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Helmut Gaus, WinSol, previously Boehringer Ingelheim, Germany
Dr Josef Hofer, EXDRA, Germany
Jiro Okazaki, Bayer Yakuhin Ltd., Japan
Werner Pelz, Carl Edelmann, Germany
Dr Jochen Scher, Boehringer Ingelheim Pharma, Germany

Objectives

The purpose of this Live Online Training is to provide an overview on measures pharmaceutical companies and suppliers can take in order to achieve "Japan Quality" for their products.

The general pharmaceutical principles (pharmaceutical legislation and authorities in Japan, Japanese Pharmacopoeia, GMP requirements in Japan) as well as current developments will be presented and the registration of medicinal products for a marketing authorisation in Japan will be discussed.

Background

All pharmaceutical companies that deliver their products (starting materials, bulk and intermediate products as well as finished products) to Japan for the first time are familiar with the situation that the recipients and the customers of the market complain about the delivered goods even though these products meet the agreed specifications.

Japanese customers attach much more importance to the visual/outward appearance of goods than the average European or North American customer. The pharmaceutical environment has coined the phrase "Japan Quality" to describe this phenomenon.

Target Group

This Live Online Training is addressed to executives and employees from the pharmaceutical and its supplier industries who work in the fields of Regulatory Affairs, Research & Development, Quality Assurance, Quality Control or production and are involved in the manufacture and distribution of products for the Japanese market.

Technical Requirements

We use WebEx Events for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Regulatory Management for Japan
  •  Management of Japan – specific  requirements in Marketing Authorisation Procedures 
  •  Establishment of Regulatory Documentation for and from Japan, International Challenges
  •  Japanese oriented Organisation and Structures in Drug Regulatory Affairs
Regulatory Requirements in Japan
  •  Japanese Pharmaceutical Authorities
  •  Development of Japanese Pharmaceutical Law
  •  Japanese System of Law
  •  Revised Pharmaceutical Affairs Law (r-PAL)
  •  GMP Regulations in Japan (J-GMP)
„Japan Quality“ – Specific Requirements for Oral Solid Dosage Forms
  •  Typical defects and their potential origin
  •  Defect classification from a Japanese point of view
  •  Organisational measures in a multi purpose production environment
  •  Potential improvement measures to minimize defect occurrence
Specific Japan Requirements Regarding Analytical Testing
  •  Pharmacopoeias in Japan (JP, JPE, JPC, JPED)
  •  JP requirements on APIs and excipients
  •  Specific requirements for analytical methods (method description, test procedure, method validation, specific test methods)
  •  Harmonisation
„Japan Quality“ – Specific Requirements for Liquid/Sterile Dosage Forms (Parenterals)
  •  Case studies within Parenterals manufacturing
  •  Implemented measures in aseptic production
  •  Increasing requirements for primary packaging materials
  •  Stragies to reduce unnecessary rejects in visual inspection
„Quality for the Japanese Market“ – The Special Requirements for Secondary Packaging Materials
  •  General expectations to folding cartons and inserts
  •  Defect evaluations of printing and finishing issues
  •  Development of a defect list specification
  •  Strategy of the packaging material producers
  •  Realisation in the daily practice

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