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Laura Brown

Director,

Dr. Laura Brown , PhD, MBA, Diploma Clinical Sciences, is an independent QA and training consultant in the pharmaceutical industry. She is a managing director with LB Training and Development Ltd., course director for the M.Sc. in Clinical Research, School of Pharmacy at the University of Cardiff, and course director for M.Sc. Regulatory Affairs, TOPRA. Dr. Brown has 20 years experience running clinical trials and clinical quality assurance in the pharmaceutical industry, and auditing clinical trials internationally. She has held a number of international and senior management QA positions in the pharmaceutical industry including her role as an associate director with a leading GCP audit consultancy.

She has worked for several international companies like GlaxoWellcome, Hoechst Marion Roussel and Phoenix International. Dr. Brown has published material on the new EU Clinical Trial Regulation and also a practical guide to the current regulatory requirements for carrying out clinical trials in the EU. She has penned a chapter on training QA staff in the leading GXP book “Good Clinical, Laboratory and Manufacturing Practices” (2007). She has authored SCRIP’s latest GCP guide and one entitled “Practical Guide to the Clinical Trial Directive”. She is also co-author of several books including “Developing the Individual” and “Project Management for the Pharmaceutical Industry”. She has regularly lectured at conferences and in training courses on QA and GXP issues.

Dr. Brown developed an e-learning module: “How to Prepare for Audit and Inspection” for Zenosis (a regulatory commercial e-learning training organization) in 2008 and is editor of an e-learning SOP series for Henry Stuart Conferences (2013). She runs many training courses on topics such as: pharmaceutical project management, understanding the pharmaceutical industry/drug development, writing and managing SOPs, GCP, regulatory requirements for clinical trials, the clinical trial directive, managing clinical trials, QA management and business skills, how to prepare for audit and inspection, how to audit, etc.



  •  Monday, October 22, 2018
  • 09:00 AM PDT | 12:00 PM EDT,
  • 2 Hours
  • ¤190.00
2-Hour Virtual Seminar on Data Integrity for GXP Compliance

Data Integrity is a critical issue in document governance. It increasingly becoming a focus for regulatory inspections globally. This webx session will equip you with knowledge necessary to identify and avoid potential Data Integrity issues before auditors do.

  •  Monday, November 12, 2018
  • 10:00 AM PST | 01:00 PM EST,
  • 60 Minutes
  • ¤150.00
How to Write SOPs which are Compliant for Inspections for a GXP Compliance

This webinar will help Sponsors, CROs in the US, EU and internationally,understand how to write SOPs to comply with inspection requirements.

  •  Friday, November 30, 2018
  • 10:00 AM PST | 01:00 PM EST,
  • 60 Minutes
  • ¤150.00
How to Audit Against ICH GCP 2 Addendum to Ensure Compliance

It is important GCP Auditors to understand how to audit the changes required by the new ICH GCP R2 Addendum. To consider how audit checklists and procedures should have been updated to ensure the new requirements are met and their organisations are ready for regulatory inspection.

  •  Wednesday, December 5, 2018
  • 10:00 AM PST | 01:00 PM EST,
  • 60 Minutes
  • ¤150.00
How to Demonstrate Vendor-CRO-CMO Oversight in the Biopharma and Device Industry

This webinar is specifically designed for sponsoring biopharma and device companies who are outsourcing.It will help you get to grips with effective Vendors (including CRO,CMO, and other vendors) management used in the biopharma and device industries and your responsibilities as the sponsor.





  • Recorded
  • View Anytime
  • 2 Hours
  • ¤240.00
2-Hour Virtual Seminar on Data Integrity for GXP Compliance

Data Integrity is a critical issue in document governance. It increasingly becoming a focus for regulatory inspections globally. This webx session will equip you with knowledge necessary to identify and avoid potential Data Integrity issues before auditors do.

  • Recorded
  • View Anytime
  • 60 Minutes
  • ¤190.00
How to Write SOPs which are Compliant for Inspections for a GXP Compliance

This webinar will help Sponsors, CROs in the US, EU and internationally,understand how to write SOPs to comply with inspection requirements.

  • Recorded
  • View Anytime
  • 60 Minutes
  • ¤190.00
EU General Data Protection Regulation (GDPR): Compliance for Drug development and Clinical Trials?

The General Data Protection Regulation (GDPR) is new legislation that had come into force on 25th of May 2018 brings substantial changes to the rules around personal data and its use. While it aims at building on existing Data Protection legislation, it represents a significant change for organisations that hold and process personal data particularly for clinical trial data and drug development.

  • Recorded
  • View Anytime
  • 60 Minutes
  • ¤190.00
How to Audit Against ICH GCP 2 Addendum to Ensure Compliance

It is important GCP Auditors to understand how to audit the changes required by the new ICH GCP R2 Addendum. To consider how audit checklists and procedures should have been updated to ensure the new requirements are met and their organisations are ready for regulatory inspection.