How to Respond Effectively to Non-conformances Cited During Regulatory Inspections
Overview
Pharmaceutical manufacturers and distributors face complex regulatory requirements from EU (EMA/NCA) and US (FDA) authorities, with distinct frameworks, inspection techniques, and expectations for product safety and quality. Non-compliance can lead to adverse inspection outcomes, jeopardizing operations and patient safety.
To ensure compliance, FDA and EU authorities conduct detailed inspections, issuing non-conformances, Form 483s, and non-conformance reports for deviations from regulations. Responding effectively requires thorough investigations, root cause analysis, and the development of corrective and preventive action (CAPA) plans.
Join our exclusive webinar on November 30, 2023, led by industry expert Charley Maxwell. Gain valuable insights on engaging with regulatory agencies, conducting comprehensive root cause investigations, and formulating effective responses to address non-conformances which arise during regulatory inspections.
Register now to secure your spot and equip yourself with the knowledge and strategies needed to navigate regulatory inspections successfully. Ensure compliance, safeguard patient safety, and get back on track following adverse inspection outcomes.
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Who Should Attend:
- Quality Managers
- Heads of Quality
- Quality Directors
- Patient Safety
- Heads of Compliance
- Skill Level: Intermediate , Expert
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Topics:
- 16:00 (Central European Time) – 16:10 Introductions
- 16:10 – 16:15 The Different Agencies and their approaches
- 16:15 – 16:25 Form 483 and non-conformance reports
- 16:25 – 16:45 Expectations and timelines
- 16:45 – 17:00 Root Cause Analysis and CAPA plans
- 17:00 – 17:30 Summary and questions
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Special event information:
- All participants will get a complimentary certificate of attendance courtesy of the webinar's sponsor - Pharmalane UK.
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
Pharmalane UK
Phone
+44 (0) 203 195 3933Website
https://www.pharmalaneuk.com/PHARMALANE UK Ltd. is an ISO 9001:2015 certified Global Pharmaceutical Consultancy (specialised in GxP audits) registered with the Registrar of Companies for England and Wales, UK, and catering to the clients across the globe.
Additional Partners
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Orion GXP Consulting
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Email
info@oriongxp.com -
Website
https://oriongxp.com -
Orion GxP Consulting provides contract QP and RP services and consultancy support to pharmaceutical manufacturing and distribution clients, such as training and expert knowledge. Orion GMP Consulting draws on the experience of our consultants and their links to the pharmaceutical industry through consulting and QP/RP roles to assist their clients in developing, managing, and continuously improving their quality systems.
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If you attend the live session you will get a digital certificate of attendance emailed to you within 7-working days.
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