Effective documentation of analytical procedures is essential to ensure that testing required by regulatory agencies is performed correctly and consistently. This webinar will cover some of the common mistakes made while writing analytical procedures, and will give examples of best practices to be followed.
The webinar will teach participants on how to write analytical procedures that are easy to understand, unambiguous and technically correct. Businesses will benefit with reduction in the number of mistakes and repeat analysis due to poorly-written analytical procedures.
Areas Covered in the Session :
- Format and content of analytical procedures
- Avoiding ambiguity in the method’s scope
- Appropriate instructions and equipment for sample preparation
- Documenting instrument parameters
- Safety instructions
- System suitability
- Chromatographic integration
- Practices that aid compliance with data integrity requirements
Who Should Attend:
- Regulatory Departments
- Quality Assurance Departments
- Quality Control Departments
- Teams involved in the development of Analytical Procedures
Course Director: DR. MARK POWELL
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.