Important GMP Regulatory Intelligence Digest for 2022/23
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Overview
As a busy Quality Professional, staying updated on important regulatory changes may be difficult.
2022 and 2023 bring many impending changes to GMP chapters, annexes, and new regulations to replace older European directives. Additionally, Mutual Recognition Agreements and Brexit carry new challenges you must prepare for.
This webinar will make it easier for you to catch up on all the important regulatory intelligence over the past year and help plan for implementation into routine operations in 2023.
We will cover the most significant updated and new guidelines in the past 12 months, including the following:
– The introduction of Eudralex Vol 4, Annex 21
– Updates to Eudralex Vol 4, Annex 1
– The coming into force of the Clinical Trials Regulation (Regulation (EU) No 536/2014) and associated delegated regulation and supporting guidelines.
– The coming into force of Regulation (EU) 2019/6 on Veterinary Medicinal Products
– The latest intelligence on the impact of Brexit, NI Protocol, and NI Protocol Bill.
Don’t miss this exclusive webinar! Register now and join us on 13 Dec 2022 to ensure there are no gaps in your regulatory intelligence and you have everything covered.
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Who Should Attend:
- QA Managers
- Regulatory Managers
- Heads of Quality
- Quality Directors
- Skill Level: Intermediate , Expert
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Topics:
- What is regulatory intelligence, and why is it important
- Annex updates – Annex 21 and Annex
- Clinical Trials Regulation (EU) No 536/2014
- New Veterinary regulation (EU) 2019/6
- Latest Brexit impact
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Special event information:
All live participants will receive a free certificate of attendance courtesy of the event's sponsor, Qualifyze.
Speaker
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Charley MaxwellManaging Director & Consultant QP / RPCharley is the owner and Managing Director of Orion GXP Consulting. He has over 20 years of experience working in manufacturing QA, regulatory compliance, batch release, and distribution in the pharmaceutical and medical device industry. He has assisted multiple clients with designing, developing, and implementing phase-appropriate Quality Management Systems, vendor management, audit programs, quality risk management, and training. Charley has a Bachelor’s of Science In Biochemistry and a Master’s In Pharmaceutical Manufacturing Technology. He has acted as a QP in Ireland for sterile and non-sterile manufacture, clinical IMP release, and third-country Importation.
Partner
Qualifyze
Website
http://www.qualifyze.comThe Qualifyze mission is to build the trust layer for global supply chains by creating a digitally connected ecosystem. They operate the first online platform for GxP audits that connects pharma companies, suppliers, and auditors.
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