| Activity examples based upon experience |
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| Consultancy |
Training |
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| 1. Compliance |
1. General quality |
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| GLP or ISO guidelines |
Introduction to Quality |
| Guideline analysis | Process, procedure, SOP’s |
| Laboratory situation analysis | Definitions of quality |
| Installation of quality systems | Examples of quality & quality costs |
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| Multi site studies |
Quality Philosophies &Tools |
| Situation analysis | The early Americans |
| Responsibility documentation | The Japanese waves |
| Service level agreements | The new Western wave |
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| Inspection preparation |
Personal quality |
| Gap identification | Competences (knowledge, skills, attitude) |
| Milestone planning& team dedication | Project management & planning skills |
| Coaching & follow-up | Communication & Leadership |
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| 2. Improvement |
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| Analysis & priority planning |
Organisational quality |
| Self assessment according to EFQM fields |
Mission, vision & strategic planning |
| Scoring techniques & Priority setting |
Quality systems (QAU, TQM, …) |
| Translation in SMART actions |
Success factors & performance indicators |
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| Milestone planning & project teams |
Formal quality systems |
| Project definition & determination of needs |
Quality control, management, assurance |
| Team composition & responsibilities |
Introduction to ISO systems |
| Team life cycle & deliverable planning |
Introduction to GXP’s, Pharmacopeia, … |
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2. Laboratory quality |
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| Evaluation & Implementation |
Certification & Accreditation |
| Plan, Do, Check, Act cycle (Deeming wheel) |
Product certification (safety, quality, bio, …) |
| Growth by small improvements |
System certification (ISO 9000, 9001, 9004) |
| Growth by innovation |
Laboratory accreditation (ISO 17025, …) |
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| 3. Efficiency & Excellence |
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| Vision & Strategy setting |
Hazard Analysis of Critical Control Points |
| SWOT analysis |
Basic principles (kinds of hazards, 7 steps) |
| Mission & Vision |
Practical approach: examples |
| Strategic planning |
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| Critical success factors |
Statistical quality methods |
| Strategic success factors |
Statistical process control & Six Sigma |
| Functional success factors |
Control charts & warning/action limits |
| Operational success factors |
Random samples & characteristics |
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| Indicators & results |
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| Objective indicators & results |
Measurement uncertainties & implications |
| Perception measurement & results |
Daily control methods |
| Trends |
Periodical calibration methods |
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Initial validation methods |
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Instrument life cycle & documentation |
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Selection & installation (incl. validation) |
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Follow-up (control, calibration, adjustment…) |
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Defect & Out-of-use management |
Reflector Consulting provides services in chemical pharmaceutical and biomedical Research & Development. Areas of expertise are TOXICOLOGY program design, study monitoring and regulatory documentation on the one hand, and QUALITY aspects, including compliance and efficiency improvement on the other hand.