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Join industry experts at the Extractable & Reachable Summit 2022 to explore essential practices, regulatory updates, and safety measures in drug and medical device development.
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Gather all necessary documentation related to the extractables and leachables testing.
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Who needs extractables leachables summit 2022?
01
Regulatory professionals in the pharmaceutical and medical device industries.
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Quality assurance and quality control personnel responsible for product safety.
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Research and development teams involved in product innovation.
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Supply chain professionals managing materials and packaging.
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Consultants and experts in extractables and leachables testing.
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Industry stakeholders seeking compliance with safety regulations.
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What is extractables leachables summit?
The Extractables Leachables Summit is a key event focused on understanding and discussing the safety and regulatory compliance related to extractable and leachable substances found in pharmaceutical and medical device packaging.
Who is required to file extractables leachables summit?
Manufacturers and suppliers of pharmaceutical products and medical devices that involve packaging or materials that may interact with their products are required to file for the Extractables Leachables Summit.
How to fill out extractables leachables summit?
To fill out the Extractables Leachables Summit, participants must gather relevant data on extractables and leachables, adhere to specified formats, and ensure that all analytics, risk assessments, and compliance measures are clearly documented.
What is the purpose of extractables leachables summit?
The purpose of the Extractables Leachables Summit is to ensure that materials used in packaging and manufacturing do not release harmful chemicals into pharmaceutical products, thereby guaranteeing safety and compliance with regulatory standards.
What information must be reported on extractables leachables summit?
Information that must be reported includes analytical data, materials and methods used, risk assessments, findings regarding potential extractables and leachables, and measures taken to ensure compliance.
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