Event type:
1 day, professional development training course

Recommended for:

Auditors, scientists and managers
Great tutors which made the course delegates very interactive. All aspects very informative and well presented.
Tutors:
Janet Downie, Chief Operating Officer for Roslin Cells Ltd. 
Gordon MacDonald,  Director Quality Global Customer Lead, Fisher Clinical Services

course programme and information

Course information:
This course is designed to provide comprehensive guidance and practical help for technical, supervisory and supporting Quality Assurance personnel within the pharmaceutical laboratory on approaches to take and what to look for when undertaking GMP analysis of pharmaceutical, biopharmaceutical and biological samples. The course will address the current regulatory framework for laboratory work conducted to support GMP activities with reference to development, release and stability testing of Investigational and Commercial products. Comparison with relevant Good Laboratory Practices, in support of pre-clinical studies, will be made.

Who should attend?
  • Technical personnel within the laboratory 
  • Laboratory supervisors and managers 
  • Quality assurance personnel supporting the laboratories/activities 
  • Project managers responsible for outsourced laboratory work

Benefits Include:
  • Guidance on the interpretation and application of Good Manufacturing Practice within the Pharmaceutical Laboratory 
  • An opportunity to improve delegates’ understanding of the GMP requirements as they are applied in the laboratory 
  • Awareness and sharing of current regulatory inspection findings within the laboratory 
  • Access to an experienced panel of speakers

Day 1

9.15 Registration 
9.30 Welcome 
9.45 Introduction to the Regulations Relevant to Laboratory Work 
A review of EU GMP regulations and a comparison with GLP requirements. 
10.15 What Does the Laboratory Do? Assay types undertaken, microbiology testing, method validation, data from generation to reporting, electronic records. 
10.45 Break 
11.00 When Things Go Wrong Deviations, OOS, investigations, complaints, corrective and preventive action. 
11.45 Workshop – Out of Specification Results and Deviations 
12.30 Workshop – Feedback 
12.45 Lunch 
13.30 Laboratory Equipment Qualification and Maintenance Approaches to qualification and maintenance, considering risk and simple versus complex equipment. 
14.15 GMP Work in a GLP Laboratory Differences between GMP and GLP requirements, QA input to OOS and deviations, auditing and report approval. 
14.45 Workshop 2 – Contract Testing 
15.30 Workshop 2 – Feedback 
16.00 Break 
16.15 Regulatory Inspection Findings in Laboratories Regulatory inspection programmes, expectations and common findings. 
16.45 Questions and Answers Answers to delegates' outstanding questions. 
17.00 Close of course
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