Location

Productivity and Quality Institute - Alexandria

Objectives

• Upon the successful completion of this course, each participant will be able to:-• Apply the latest techniques in laboratory quality management and its standard operational procedures, accreditation, documentation and auditing (laboratory auditing) based on GLP requirements• Recognize the requirements of GLP certification and review the certification process• Design and develop laboratory documents (SOP) and recognize the information they should contain, employ an effective writing style as well as maintain documents up to date• Understand the GLP requirements and how to implement them effectively within the pharma labs• Develop, implement and maintain a long term effective laboratory quality system in the long run in compliance with the GLP requirements.

Outcomes

It will provide insights into key clauses and concepts that underpin an effective QMS, enabling participants to commence their journey to implementing an effective QMS aligned with GLP.Attendees will receive practical instructions on the development, implementation and long-term maintenance of an effective laboratory quality system.In addition to the updated knowledge provided to course participants during the course period, each participant will go back to his/her laboratory equipped with an example for typical SOPs that can be modified and used within participant’s laboratory

Course Contents

• Introduction to the Principles of GLPo Introductiono Overview of a lab-focused QMS (ISO 17025)o The Fundamental Points of GLP: (purpose, structure and requirements of GLP)o GLP Principles. What’s the same – what’s different from ISO 17025o Accreditation and QS Certification benefits.• Resourceso The role of Managemento Personnel – competency, roles, responsibilities and trainingo Infrastructure: GLP requirements for facilities / buildings and Equipment• Characterizationo The Test Itemo The Test Systemi. Receiptii. Storageiii. Preparationiv. Administrationv. Observations and Test Resultsvi. Reporting• Ruleso The Protocol and Study Plani. Why is it important to identify the start and end datesii. How to handle amendments to the protocoliii. How to handle deviations from the protocoliv. Difference between a deviation and a planned changev. Review and approval process (scientific and compliance)o Standard Operating Procedures (SOPs) and Testi. Methodsii. Is i