Annex 1 Manufacture of Sterile Medicinal Products

  • Product Id : FDB2641
  • Category : , ,
  • Presenter :
  • Scheduled On : October 15 2018 9:00 am
  • Duration : 60 Minutes


    US and Canada
    9 AM EDT

    Central Europe
    3 PM CEST

    UK and Ireland
    2 PM BST/IST
    .

Knowing and applying the GMP regulations is one of the key elements in the manufacture of medicinal products, particularly in the manufacture of sterile medicinal products. Major changes have recently been made to the EU GMP guideline covering manufacture of sterile medicinal products (Annex 1).

This webinar is designed for staff who are new to working in sterile manufacturing or who wish to learn about the recent Annex 1 revisions. It will discuss what controls and documentation must be in place to ensure product quality and patient safety for both aseptically prepared and terminally sterilized products.

Areas Covered in the Session :

  • GMP regulation of sterile products
  • Why are sterile products different?
  • Background to the Annex 1 guideline
  • Importance of product, equipment and people flow
  • Room classifications and particulate monitoring
  • Sterilization methods for materials and equipment
  • Contamination by operators: the importance of gowning
  • Water systems
  • Media fills
Who Should Attend:

  • Staff involved with manufacture of sterile medicinal products to be marketed in EU
  • Quality Assurance Departments
  • Manufacturing Departments
  • Regulatory Affairs Departments
  • Research and Development Departments
  • GMP/GDP Compliance Departments
  • Contract Manufacturing Organizations

FDB2641

Robert Haslam

Robert Haslam, Managing Director, Somerset House Consultants has over forty years of experience in Quality Assurance, Production, Development, Clinical Trials and Regulatory Affairs gained in multinational and start-up companies. He is the Managing Director of a consultancy providing quality assurance, manufacturing, development and training support to pharmaceutical companies worldwide. He is an EU ‘Qualified Person’ for marketed and investigational products, including steriles and non-steriles, generics, biopharmaceuticals, herbals. He is also an ISO-qualified Lead Auditor; experienced in EU & FDA Good Manufacturing Practice.

He has extensive experience in GMP audits of drug substance, drug product and Investigational Medicinal Product manufacturers; outsourced activities; supply chain risk management. He has a successful track record of strategic management, facility qualification, designing and implementing quality systems, managing quality remediation programs, product development and outsourcing. He has designed and delivered bespoke GMP training courses to companies worldwide. Expert witness in litigation involving GMP compliance.

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  • Presentation Handout in .pdf format
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