Why you should Attend
The use of appropriately-validated test methods is an essential requirement of Good Manufacturing Practice. This course provides an overview of current regulatory guidance, as well as practical advice on planning and executing method validation and verification studies. Group exercises and case studies are used to reinforce learning.
Areas Covered in the Session
- Understand regulatory expectations for method validation/verification
- Be familiar with validation terminology and experimental approaches to method validation
- Know how to write effective test methods and validation protocols
- Be able to set meaningful acceptance criteria
- Understand the extent of method validation required at each stage of development
- Have strategies for dealing with validation failures
- Understand how to set system suitability limits
Who Will Benefit
This course is intended for personnel involved in pharmaceutical method validation or the verification of compendial methods.
- QA/QC Managers and Personnel
- Validation Specialists
- Analysts and Other Laboratory Staff
- Lab Supervisors and Managers
- Regulatory Affairs
- GLP/GCP/GMP Auditors
- R&D
Speaker Profile
Mark Powell set up Mark Powell Scientific Limited to provide technical support for pre-clinical drug development, which may involve short-term help with specific problems or management of the analytical aspects of a development project, for new or existing compounds, as part of a multi-disciplinary team.
He has an expertise in analytical method development and validation (including assay of impurities), design of stability testing studies and auditing of contract laboratories. Mark is also an experienced quality auditor, and can perform GMP audits of contract laboratories, including evaluation of compliance with data integrity requirements.
He also provides training services, which are accredited by the UK's vocational skills agency, Cogent SSC, and are designed to ensure that analysts have the necessary theoretical and practical skills to perform their jobs competently. As well as courses in instrumental chemical analysis, He also provides training in basic laboratory skills and technical writing (analytical methods, SOPs and technical reports). Mark has recently been working with Spectroscopy Magazine to write and deliver an on-line training course in UV spectroscopy and has also been asked to provide training on behalf of the chromatography consumable company Hichrom.
Instructor
Mark Powell