Laboratory Quality Risk Management-Tools & Techniques

Code

846

Start Date

2025-10-05

End Date

2025-10-09

City

Casablanca

Price

4450 $

Language

Participants

1-15

Hotel

Hotel Meeting Room

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Introduction:

Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. In the pharmaceutical sector, the principles and framework of ICH Q9, coupled with the official ICH training material that supports this guideline, are instrumental in enhancing the application of effective quality risk management by industry and regulators. The importance of quality systems has been recognized in the pharmaceutical industry and it is evident that quality risk management is a valuable component of an effective quality system.

It is commonly understood that risk is defined as the combination of the probability of occurrence of harm and the severity of that harm. However, achieving a shared understanding of the application of risk management among diverse stakeholders is difficult because each stakeholder might perceive different potential harms, place a different probability on each harm occurring and attribute different severities to each harm. In addition, subjectivity can directly impact the effectiveness of risk management activities and the decisions made. In relation to pharmaceuticals, although there are a variety of stakeholders, including patients and medical practitioners as well as government and industry, the protection of the patient by managing the risk to quality and availability, when availability risks arise from quality/manufacturing issues, should be considered of prime importance.

Who Should Attend?

Those in management, quality, development, compliance, laboratory operations, and other technical areas such as:
- QA managers and personnel
- Analysts and lab managers
- Validation specialists
- Training departments
- Documentation department
- Suppliers of reference material

Course Outline

Day 1:
- The Importance of analytical work
- Purpose of analysis
- Social and economic impact of a ‘Wrong Analysis’
- What is ‘Quality?
- Quality control & proficiency testing
- Laboratory Audit and Review
- History of ISO 17025
- Definitions & terms
- Different standards and their main features
- Relationship between ISO 17025 and ISO 9001
- Summary of ISO Standard 17025
Day 2:
- Technical requirements
- Scope of accreditation
- Who is authorized to provide official accreditation
- International recognition of accreditation
- Selection of a suitable accreditation body
- How to achieve ISO 17025 certification
- Steps for ISO/IEC 17025 accreditation
- Suggested format for ISO 17025 documentation
- Financial cost of accreditation
- Monitoring & maintenance of quality system
- Planning audit and review programme
Day 3:
- Frequency of audit and review
- Audit summaries
- Health & safety
- Purchasing services & supplies
- Sub-contracting
- Retention & disposal of item
- Idetification & storage of item
- Administration of work & sample tracking
- Sample & sample preparation
- Sample numbers & sample size
- Specification of analytical requirement
Day 4:
- Laboratory report
- Recording of results & associated data
- Methods of record keeping
- Data organization and storage
- Laboratory information management system (LIMS)
- Guidance on writing quality manual
- Good laboratory practice (GLP)
- Laboratory management strategy
- Laboratory equipment & instruments
- Acceptability of calibration to accreditation bodies
- International recognition of accreditation:
- Selection of a suitable accreditation body
- How to achieve ISO 17025 certification
- Steps for ISO/IEC 17025 accreditation
- Suggested format for ISO 17025 documentation
- Frequency of audit and review
- Audit summaries
- Health & safety
- Guidance on writing quality manual
- Good laboratory practice (GLP)
- Laboratory management strategy
- Laboratory equipment & instruments
- Acceptability of calibration to accreditation bodies
- Statistical process control
Day 5:
- Control chart
- Control chart basic procedure
- Types of control chart
- Mean chart (X-chart)
- Warning / action limits
- Action limits
- Warning limits
- Out of control
- Laboratory data accuracy

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