About Us

Alex Hall - QPQuandary - QP | GMP | QMS | Quality Systems Training | Qualified Person | Pharmaceutical | Quality Assurance | QA | Quality Consultancy | Training for pharmaceutical company | QP training | QP training support | Alex Hall | Alex Hall
  • QPQuandary is the creation of Alex Hall.

     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).

    Since 2013 Alex has supported many QP trainees in achieving their goal of becoming Qualified Persons through working with course providers as a tutor on their QP modules and working directly with individuals, providing one on one and group mentoring.

    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.

    In addition, Alex has supported a variety of Pharmaceutical organisations as a Locum QP / QMS consultant, where she has provided a common sense approach to achieving compliant, efficient and cost effect quality systems.

Anneka Newbury - QPQuandary - QP | GMP | QMS | Quality Systems Training | Qualified Person | Pharmaceutical | Quality Assurance | QA | Quality Consultancy | Training for pharmaceutical company | QP training | QP training support | Alex Hall | Alex Ha
  • Anneka has worked in the industry for over 14 years, primarily in Quality Assurance roles at both site and Corporate levels. She has considerable experience in the maintenance and ongoing improvement of the Pharmaceutical Quality System.

    She has implemented Data Integrity strategies over multiple sites and spent a considerable time facilitating Computer System Validation activities.

    During her career she has helped improve GMDP standards, worked on site Quality metric projects and has supported regulatory inspection readiness activities as well as hosting customer and regulatory inspections.

    She achieved a First Class BSc (Hons) in Biological Sciences and is currently training to become eligible Qualified Person.

    Anneka is passionate about simplifying the Quality Processes and Creating a Culture of Quality.

QPQuandary - QP | GMP | QMS | Quality Systems Training | Qualified Person | Pharmaceutical | Quality Assurance | QA | Quality Consultancy | Training for pharmaceutical company | QP training | QP training support | Alex Hall | Alex Hall trainer
  • Tanya joined the Pharmaceutical industry in 2005, and has worked with Global companies including GSK and Sanofi, as well as smaller, family-run businesses. She holds a BSc(hons) in Biomedical Sciences from the University of Hertfordshire.

    At the start of her career, Tanya spent 8 years specializing in Microbiology QC and sterile manufacturing, including both aseptically filled and terminally sterilised products. Since moving into Quality Assurance in 2013, she has performed in Senior Quality roles- leading QA, QC and Regulatory Affairs.

    Since becoming a Qualified Person in 2019 (with training and support from Alex!) Tanya has broadened her experience to include many other non-sterile dosage forms- including oral solid dose and liquid products.

    Tanya has a passion for coaching and developing people, as well as a love for continuous improvement and remediation.

    In her spare time, Tanya enjoys gardening, working on her camper van conversion, and she also runs the Essex Japanese Shiba Inu group.

  • Greg qualified as a pharmacist and completed a PhD prior to joining the pharmaceutical industry, where he worked for Wellcome, GlaxoWellcome and GlaxoSmithKline for 37 years.

    Greg has vast experience in technical and leadership aspects of pharmaceutical development.

    He is passionate about quality systems and quality culture and has played a leading role in public consultation on Regulatory Authority Data Integrity Guidance.

    Outside of work Greg enjoys sport and revelled in the experience of bringing the two together whilst being seconded to the Anti-Doping Team as a Doping Control Station Manager for the London 2012 Olympic and Paralympic Games.

  • Mike is an experienced production and QA leader in a range of multinational operations including ex pat work in France and Brazil.

    Dosage forms covered included solid and oral liquids, topicals, aerosols and sterile products. Auditing experience has been international covering UK, EU, N America Asia Pacific.

    Mike has a particular interest in training and developing staff both those in his own team and for 18 years from across the pharmaceutical industry in Technical and Quality topics as well as behavioural aspects of Quality culture.

    Mike has an interest in Psychotherapy and in coaching and mentoring individuals.

    In his spare time Mike is involved in working with and breeding Therapy Dogs. He and his dog Maisie are keen walkers, runners and love to fly fish.

 
  • Alison has a wealth of experience in managing Operational Quality and Pharmaceutical Quality Systems at both site and corporate levels.

    Alison has a passion for enabling others to do their best work through coaching and mentoring. She understands the importance of removing complexity in operations and building a strong quality culture that prioritises the patient's well-being. Alison firmly believes that a good quality culture can significantly improve performance and help organizations achieve their goals right first time.

 
  • Qualified Person and former Director of Manufacturing with specific expertise in ATMPs and biologics including setting up of facilities and expanding or closing them.

    Passionate about translating R&D to commercial products, focussed on solving problems with QP services and quality consultancy.

    Experienced in a wide variety of dose forms, implementing eBR, LIMS, Release by Exception systems and AI / ML for KPIs.

    Has worked for all sizes of companies start ups to GSK providing a unique blend of quality and business risk understanding and management.

    Available for coaching / mentoring for trainee QPs and others involved in the pharmaceutical development and manufacturing world.

 
  • Experienced Qualified Person and Auditor with excellent interpersonal and influencing skills. Providing QP services and quality consultancy for marketed and Investigational Medicinal Products. Experience of remediation following regulatory inspections.

    Katy has experience of a wide variety dosage forms including Sterile biologicals, solid dose, Inhalation products, IMPs and Good Clinical Practice.

 

AREAS OF RECOGNISED TECHNICAL EXPERTISE IN THE TEAM 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 a wide range of pharmaceutical dosage forms 

  • Formulation, process and packaging development

  • Biological / Advanced Therapy Medicinal Products

  • Management and distribution of Investigational Medicinal Products 

  • Marketing Authorisation and Clinical Trial Authorisation Application support 

  • Good Manufacturing & Good Distribution Practice 

  • Good Clinical Practice

  • Continuous Improvement Tools 

  • Technical writing – SOPs, Reports etc 

  • Quality Risk Management

  • Quality Systems Design and Implementation / Remediation

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 

  • Quality Culture