Changes in the manufacturing of API and medicinal products must be carefully planned, evaluated and implemented to ensure compliance with the Marketing Authorization.
Alongside the EU GMP Guidelines and the EU Regulation 1234/2008 (Variations Guideline), Change Management is relevant for the complete Product Life Cycle.
Development Phase – Commercialization Phase – and Phasing-Out of API and medicinal products are covered. Through intelligent design, forward-looking process planning and a suitable control strategy (life cycle approach according to ICH Q12 guideline) may be chosen. Post-Approval_Change-Management_protocols (PACMP) may be used for this approach.
The scope of the Live Online Seminar "Change Control - from planning to implementation" on April 29 and 30 is to convey practical knowledge in this area.
gempex supports the event with many years of expertise at the interface of practice, regulation and quality assurance. As an expert for Annex 1, Dr. Martin Melzer, Principal Consultant at gempex, will shed light on key topics such as:
- Definition and categorization of approval-relevant changes
- Planning changes with an impact on licensing
- Life cycle management in the GMP context
The seminar is part of the "GMP-Compliance / Quality Assurance" course organized by Concept Heidelberg. Participants from the pharmaceutical, chemical and biotech industries will receive a comprehensive overview of all relevant aspects of change management in the seminar. The event is aimed at employees in the areas of production, technology, quality assurance, quality control, IT, licensing or project management.
The requirements for change management are made tangible using concrete practical examples. The knowledge imparted will be deepened in interactive workshop sessions.
For questions about change control, change management and GMP compliance, please contact Dr. Martin Melzer via contact@gempex.com.
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