Effectively Managing OOS Results - Seminar One

09/18/2009 - 10:01am
Etc/GMT-8

Cost Effective and Convenient - in your office or conference room

Effectively Managing Out of Specification (OOS)
Results for Pharmaceutical Manufacturers

Seminar One - Laboratory Investigations

Conducted by David Inglis, Ph.D.
President - Ulverston GMP Consulting Ltd.

September 18, 2009

This is the first of two one-hour web seminars designed to guide and develop your understanding of:

  • Regulatory Requirements for OOS Investigations
  • Secure Strategies for Compliance   
  • How to Manage Typical Issues that Arise

Both European Regulators and FDA expect pharmaceutical products manufacturers to have in place an effective system for Investigation of Out-of-Specification results (OOS), linked to their CAPA system. This system must lead to correction of laboratory and process deficiencies and to overall quality improvement.  A high proportion of observations/citations relate to inadequate or incomplete CAPA, resulting fro OOS results.  A secure system for management of OOS results (Non-Conformances) ensures that all products on the market are safe and meet their registration requirements.

Who should attend:

  • QA Managers
  • QC Laboratory Managers
  • Qualifed Persons
  • Production Managers
  • Regulatory Compliance Managers
  • Process Development Managers
  • QA Inspectors
  •  QC and QA Supervisors

 

In this unique web seminar format, lasting just one hour, you will be able to follow along with a PowerPoint presentation, ask questions, and interact with Dr. Inglis. An outline of this seminar and Dr. Inglis' qualifications can be found below.

BONUS DOCUMENTS
1.  QC Laboratory Investigation Report Form
2.  FDA Final Guidance Document for OOS

Effectively Managing OOS Results
Seminar One - Laboratory Investigations

Part I - What is an "Out of Specification"
(OOS) Result? 

  • Definition of OOS
  • Common misconceptions
  • Reporting test results - Out of Precision
  • Reporting test results - Averaging

Part II - Roles within OOS Investigations

  • The role of the QC laboratory
  • The role of Quality Assurance

Part III - Investigating an
OOS Result (Phase 1) Laboratory
Investigations

  • Responsibilities of the Laboratory Analyst
  • Responsibilities of the Laboratory Supervisor/Investigator

Part IV - Structure Laboratory Investigation

  • Plan - Review - Plan - Review - etc.
  • Use of retesting
  • Avoiding the accusation of "Testing into Specification"

Part V - Wider Aspects of Laboratory
Investigations

  • Stability trials and field alert reports

Part VI - Questions and Answers

  • Dr. Inglis will field your questions live on the phone. You will hear all questions and answers from all participants of this seminar.

 

Register now!

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Get the MP3 file and handout
GMP090918E - MP3 audio file and Handout materials
Effectively Managing OOS Results - Seminar One 		$397.00 Add to Cart

Instructor

David Inglis, Ph.D.

DR DAVID INGLIS is director of Ulverston GMP Consulting Ltd, specialising in GMP/Quality Assurance for the manufacturing sectors of the pharmaceutical and consumer healthcare industry.  He has extensive experience in assessment and improvement of QA/GMP systems, auditing, GMP training, inspection preparation and plant cleaning/decontamination, especially in bulk intermediates and APIs.  He has a higher degree (Ph.D.) in enzyme chemistry (affinity chromatography).

During more than three decades in Quality Assurance in the pharmaceutical industry, Dr Inglis has gained extensive experience of Quality Management, through roles in QA laboratories, GMP compliance and regulatory compliance.  He successfully pioneered automated HPLC methods, and then managed all aspects of QC laboratories before spending the following 11 years managing and developing Quality Assurance, including documentation, control of change, auditing and routine regulatory compliance to cGMP.  He is a Qualified Person under EU Regulations, formerly for bulk sterile antibiotics and now for bulk product intermediates in clinical trials and for medicinal products imported into the EU.

Dr Inglis is an experienced international auditor of suppliers and contractors and has successfully prepared several sites for FDA/MHRA inspections, including FDA Systems- based inspections.  He has extensive experience of being the lead spokesman during major regulatory inspections.

Dr Inglis is a specialist in cGMP training and QA system improvement.  His flagship improvement package details a system of secure GMP compliance at competitive cost.  For conceiving and developing this package, Dr Inglis received the highest level of recognition for excellence from a global pharmaceutical manufacturing company.