QPQuandary
Call QPQuandary on: 07813 677741

Who We Are

 

 

QPQuandary is the creation of Alex Hall CSci, CChem, MRSC, PG Dip

 Following a start in the food industry; Alex entered the Pharmaceutical industry in 1990, starting out in the analytical laboratories before moving into Quality Assurance, working with major pharma companies including Roche, Eli Lilly and Eisai.

Alex became a Qualified Person (QP) in 2000.

During her career Alex has supported the training and development of QPs both as a member of the Pharmaceutical Quality Group (PQG) committee and during her nine years as a QP Assessor for the Royal Society of Chemistry (RSC).

Alex is passionate about the valued role the QP plays within an ever changing and complex pharmaceutical supply chain.  Alex’s style is to encourage the candidate to take personal responsibility for development, providing a creative and stimulating atmosphere to get the best from them in a secure training environment.  Alex has a talent for mentoring and explaining complex concepts in a simple manner.

Alex has a proven track record in providing a results orientated, person focused coaching programme.  She looks beyond the hurdle of the QP viva and seeks to develop the candidate to be prepared to take on the challenges faced by all quality professionals in a changing pharmaceutical business environment and challenging regulatory landscape.  This assists the candidate in becoming a key player in your organisation with the necessary technical and personal skills.

Areas of recognised technical expertise include:

  • Qualified Person Training and assessment process
  • Pharmaceutical Law
  • The role and duties of the Qualified Person
  • Pharmaceutical Quality Management Systems
  • Pharmaceutical Quality Risk Management
  • The manufacture and control of oral solid dose products
  • Management and distribution of Investigational Medicinal Products
  • Marketing Authorisation and Clinical Trial Authorisation Application support
  • Good Manufacturing & Good Distribution Practice
  • Continuous Improvement Tools
  • Technical writing – SOPs, Reports etc

Areas of recognised personal development expertise include:

  • Coaching and Mentoring
  • Personal Development Planning
  • Management by Objectives
  • Presentation Skills
  • Problem Solving and Decision Making Tools
  • Root Cause Analysis
  • Leadership development

Latest QP Question

What are the requirements for unlicensed medicinal products in the UK, do you need QP certification? Where would you find guidance?

Latest QP Scenario Practice

Iron Oxide - used as an excipient in many of your products. You find that the supplier has been irradiating the material without your knowledge. What implication does this have for your product? What does this mean for the effectiveness of your supplier oversight and PQS?

Testimonials

"The knowledge, guidance and advice provided by Alex was excellent. Alex has first hand knowledge of the requirements needed for candidates to be successful QPs and provides a level of training to meet these requirements. I can highly recommend QPQuandry as a service provider"
Alex Hern, Sanofi.

Read More...

Contact Information

20 Playfield Close, Biggleswade, Bedfordshire, SG18 8JL
Phone: 07813 677741
Website: http://www.qpquandary.co.uk
Email: alex@qpquandary.com"