Fresh faces at Inspired

Over the last couple of months our delegates have met with some new members of our permanent and associate training team:

Richard Atkinson

Richard worked for 22 years at GlaxoSmithKline focusing primarily on late-stage Research and Development and new product introduction into commercial manufacturing facilities. Richard has a proven track record in making major contributions to new product launches. He has a significant knowledge of global regulatory requirements, stability, analytical validation/transfers and conducting laboratory & manufacturing investigations. In addition, he has led numerous QMS projects and his audit experience spans fronting aspects of FDA and MHRA inspections, assessing Third-Parties and leading internal inspections. He has devised and delivered highly impactful training on a wide range of topics including method techniques, Laboratory investigation and Root Cause Analysis for complex problem solving. Richard brings a broad range of recent industry experience and knowledge to the training arena, a subject to which he is very passionate.

Ruth Downs

Ruth has over 35 years’ experience in the pharmaceutical industry beginning in analytical R&D and Quality Control functions before transitioning to Quality Assurance in 2002. She became a full time Global Quality GMP auditor in 2007 for a biologics company, conducting internal manufacturing and external supplier audits. Most recently Ruth gained experience in Good Clinical Practice and Good Pharmacovigilance practice Quality systems and has led audit and inspection management activities for all GxPs. In 2016 she resumed her full-time audit career as a global quality auditor and after 2 years of extensive global travel and GMP/GDP audits, she held the position of Director of Global Quality managing a team of GxP auditors and promoting improvements to the audit quality systems and working practices.

‘Evergreen’ articles updated and refreshed

When Inspired was first set up a lot of really useful articles were published on key topics in the pharmaceutical industry. Many people still read these articles but because they were published over 10 years ago some readers have queried their validity today. Consequently over the last 3 months some of these articles have been reviewed and updated. They include:

• Basic audit findings and EU GMP clauses
• Auditing – Opening and closing meetings – How to do them professionally
• The Focus of Audits – Have we got it right?
• Quality Assurance or Quality Control?
• ISO 9001 versus GMP – Part 1
• ISO 9001 versus GMP – Part 2
• CAPA – time for a rethink?
• Dealing with problems – for good
• GMP Calibration
• Documents required by EU GMP

Just click on the article in this list to see the full text.

Finally…

Please feel free to contact us at info@inspiredpharma.com with any comments on our courses, website or any areas where we may be able to help you in some way.

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