Good laboratory practice - refresher seminar

Content

Good Laboratory Practice (GLP) was enshrined in the Chemicals Act in the 1990s as a standard for the safety of new products due to numerous scandals in the authorisation of pharmaceuticals and biocides. Like all regulations, Good Laboratory Practice is subject to continuous change and must be adapted in line with scientific progress. This seminar summarises the most important current trends in Good Laboratory Practice over the last 5 years. The aim is to bring the participants up to date with the requirements of the authorities for Good Laboratory Practice. 
 

Learning objectives

After the seminar

• you will be familiar with the latest documents from the relevant international organisations
• understand how to implement data integrity and data governance (Industry 4.0)
• you will be prepared for the latest trends in inspections by authorities
   

Programme

Validation of computerised systems (OECD 17 and 22)

• Regulatory principles ALCOA, ALCOA+
• Data Integrity, Data Life Cycle, Data Governance
• Metadata, true copy, electronic signature
• Electronic archiving
  Other new OECD documents 
• Influence of the sponsor
• Extension of the test objects subject to GLP
• New QA areas of responsibility
  The new inspector manual 
  Current inspection trends