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Health and safety-Compliance with ICH Guidelines for GMPs

FDA, cGMP Regulatory Inspections,Health & care,Law,Risk assessment


NetZealous LLC

Summary

Price
Save 88%
£29 inc VAT (was £242)
Offer ends 31 August 2021
Study method
Online, self-paced
Duration
3 hours
Access to content
6 months
Qualification
No formal qualification
Additional info
  • Tutor is available to students
  • Certificate of completion available and is included in the price

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Overview

It has often been stated that "FDA inspects for compliance; European inspectors inspect for adequate science".

Yet GMPs have been enshrined into law for many countries and a drug/biologic/medical device manufacturer should have a reasonable expectation of all inspections being the same.

ICH Q7 was established by US / EU and Japan to harmonize inspections in their respective countries. This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA. After this event, you will be fully prepared for cGMP regulatory inspections in those countries.

Description

Areas Covered in the Session: US, EU, Japan GMP Requirements (Practical ICH Area Differences, Healthcare Authority Inspection Focus)

  • U.S., EU and Japan GMPs - Status of Harmonization & FutureTrends
    • Current status of harmonization of GMP requirements
    • Future Trends
  • Where Inconsistencies Become a Problem: WHO, ICH, Countries
    • Discrepancies in global expectations
    • Alignment issues
  • Key Chapter Reviews
    • ICH GMP organization
    • Category reviews
  • Compliance with ICH Guidelines for GMPs
    • Understanding and Insight into Healthcare Authority expectations
    • How GMP requirements/inspections can differ with a single ICH Standard
    • How regulators (from 3 regions) will assess / enforce compliance with Q7
  • APIs
    • Auditing API facilities
    • Typical audit agenda
    • ICH Area differences
  • Finished Products
    • Auditing finished product facilities
    • Typical audit agenda
    • ICH Area differences
  • Excipients
  • Sterile products
  • Biologics
  • Clinical Packaging
  • Area GMP Inspections
    • Differences on how GMP inspections are conducted
    • Areas of GMP inspection focus by area
    • Modifying your self-inspection systems to customized area concerns
  • Outsourcing Management Regional Perspective on:
    • Contract manufacturing
    • Contract packaging
    • 3rd Party Contract testing
  • Auditing Your Facilities for Global Considerations
    • Importance of pre-audits to regional GMP focus
    • How to focus your internal audits to a US, EU and Japan compliance system

Who is this course for?

This Webinar will provide valuable assistance to all License Owner personnel in the Pharmaceutical, Biotechnology, Medical Device and Combination Products areas, including contract manufacturers, packagers and suppliers. Particular functional expertise, for both full time and consulting personnel that would receive value from attending includes:

  • Manufacturing
  • Quality Control
  • Quality Assurance
  • Senior management
  • Project Managers
  • Qualified Persons (QPs)
  • Regulatory Compliance
  • CMC Personnel
  • Packaging Experts
  • Auditors and Staff
  • IT Subject Matter Experts

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FAQs

What does study method mean?

Study method describes the format in which the course will be delivered. At reed.co.uk courses are delivered in a number of ways, including online courses, where the course content can be accessed online remotely, and classroom courses, where courses are delivered in person at a classroom venue.

What are CPD hours/points?

CPD stands for Continuing Professional Development. If you work in certain professions or for certain companies, your employer may require you to complete a number of CPD hours or points, per year. You can find a range of CPD courses on reed.co.uk, many of which can be completed online.

What is a ‘regulated qualification’?

A regulated qualification is delivered by a learning institution which is regulated by a government body. In England, the government body which regulates courses is Ofqual. Ofqual regulated qualifications sit on the Regulated Qualifications Framework (RQF), which can help students understand how different qualifications in different fields compare to each other. The framework also helps students to understand what qualifications they need to progress towards a higher learning goal, such as a university degree or equivalent higher education award.

What is an ‘endorsed’ course?

An endorsed course is a skills based course which has been checked over and approved by an independent awarding body. Endorsed courses are not regulated so do not result in a qualification - however, the student can usually purchase a certificate showing the awarding body’s logo if they wish. Certain awarding bodies - such as Quality Licence Scheme and TQUK - have developed endorsement schemes as a way to help students select the best skills based courses for them.