Menu
This event is cancelled or expired.
Apr
2017

Quality Management Systems - QP Module

United Kingdom, York

4 Apr 2017 - 7 Apr 2017

Entrance: £3,395.00 (excl.VAT)

Lunch: included
Multiple delegate discounts available. Discounts also offered to NHS staff, charities and regulators.
Targeted audience: Aspiring Qualified Person Pharmaceutical Technical Professional
Add

Course Overview :

In this intensive, highly interactive 5-day course you will learn the essential elements of an effective, compliant, modern quality management system and how to implement, monitor and manage a system to meet the needs of all the major international regulatory agencies. Learn how to simplify systems and add value to your company, not just cost! This course is also RSC Approved.

About This Course :

The quality of your products depends on the quality of your people and the effectiveness of the Quality Management System (QMS). Properly functioning, your QMS should be your Business Management System and should drive continuous improvement and cost saving.

As QPs and quality professionals, you can’t certify or release products and stay in business unless your QMS is in control.

  • How to handle supply chains of increasing complexity
  • How to do more with less
  • Your questions answered
  • Simplify your QMS to improve speed and flexibility
  • Essential training for anyone who owns part or all of the QMS
  • Invaluable oversight for senior leaders
  • Meets the requirements of Annex 16 and other key EudraLex chapters and annexes

This highly interactive course will enable you to decide if your QMS is fit for purpose and working well or, if not, what to do about it!

This course is approved by the Royal Society of Chemistry as suitable for their members’ continuing professional development.



Registration link :

  • NSF Online registration : Link

NSF contact :

Note : 

  • All of our courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.


​

Key Learning Objectives : 

Help delegates understand :

  • What is a QMS and what is in a QMS
  • How to determine if the QMS is fit for purpose
  • Industry norms and best practices
  • QP decisions
  • How to drive continuous improvement

Course Outline :

  • Principles and expectations of the QMS
    • Product lifecycle
    • QMS elements
    • ICH Q8, 9, 10 and the QMS
  • Senior management and the QMS
  • People – selection and development
  • Documentation – data integrity
  • Change management
  • Supply chain management and GDP
  • Facilities, equipment and services management
  • Validation
  • QP relationships and release scenarios
  • Deviation management
  • Audits and self-inspections
  • Complaints and recalls
  • PQR, management reviews
  • Continuous improvement and quality metrics

We provide an optional post-course assessment.

  • No picture

    Liz Allanson

    Consultant

    MRPharmS

  • No picture

    Mike Halliday

    Executive Director

    MRPharmS, PGDip

Next

Resume

Liz Allanson is a pharmacist by profession and has a special interest in quality management and leadership skills. She spent almost 19 years as a GMP inspector with the UK MHRA, primarily as one of the senior managers in the MHRA Medicines Inspectorate. Her last position with MHRA was managing the GMP inspection team.

Ms. Allanson is eligible to act as a Qualified Person and is a registered IRCA lead auditor. Her areas of expertise include:

  • EU GMP pharmaceutical legislation and regulatory expectations, including requirements for investigational medicinal products
  • GMP and GDP compliance
  • Quality management systems
  • Clinical trial manufacture/packaging and QP release
  • Auditing and mock regulatory GMP inspections
  • Supply chain management

Mike Halliday has extensive pharmaceutical manufacturing management and QA experience, gained over 20 years working for three major international pharmaceutical manufacturers. Before joining NSF in 2003, he was Associate Director, Global Audit and Compliance for Wyeth Europa. He was also previously a partner at David Begg Associates (DBA).

Mr. Halliday is eligible to act as a Qualified Person and is an honorary lecturer at the University of Strathclyde.

He has broad experience in the manufacturing management and QA of a wide range of sterile and non-sterile dosage forms and is fully conversant with current EU and FDA GMP regulations and requirements. He has extensive experience in international QA auditing of a wide range of pharmaceutical manufacturers and specialist distributors in Europe, the Middle East, America and Asia Pacific.

Areas of recognized expertise include:

  • QP training
  • Packaging and labeling control
  • GMP legislation
  • API manufacture and control
  • Auditing and self-inspection skills – Education of auditors
  • Supply chain distribution
Login Registration