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Course summary
2 days
1,420 GBP excl. VAT
Manchester

Course description

Auditing QC Laboratories

This workshop will provide you with the necessary skills and understanding of how you can include checking for evidence of both effective data management and data fraud during chemical QC laboratory audits. It will also make sure you understand how chemical QC laboratories should manage the generation, analysis, reporting and storage of data.

*All of NSF's pharmaceutical training courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.

Suitability - Who should attend?

Regulatory concerns over pharmaceutical data integrity mean that it is essential that you conduct effective audits of your quality control (QC) laboratories.  This interactive workshop will cover the key elements of the chemical QC laboratory management system that pose the greatest risk to data integrity.  Failure to comply with basic GMP expectations can very easily be interpreted as critical data integrity issues by regulatory inspectors, so it is vital that you thoroughly audit the systems in your own company and those of any contractors you employ.

QC laboratories provide the data upon which critical decisions, such as batch release and the stability of product are based.  If the chemical laboratory data is incorrect then decisions may be wrong with potentially disastrous consequences for companies and patients.  Unfortunately, a significant proportion of recent regulatory inspection issues with data integrity have related to data generated by QC laboratories.

Training Course Content

Workshop Outline
- Overview of good control laboratory practice (GCLP) and the potential for different elements to impact data integrity
- Planning an audit of a QC laboratory
- Best practices for laboratory documentation
- Sampling and management of lab sample
- Qualification and calibration of laboratory equipment
- Classifying laboratory audit findings
- Validation, verification and transfer of analytical methods
- Chromatography; a risk area for data integrity
- Managing OOS & OOT results; investigations and reporting
- Preparation of an aide-mémoire to audit a laboratory

Expenses

Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.

About provider

pharma training courses

NSF International provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of the most knowledgeable experts in their fields. Our unique...


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Contact info

NSF International, Pharmaceutical Services

The Georgian House, 22/24 West End
Kirkbymoorside
YO62 6AF York


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