COMPANY PRESENTATION

1. Education and Consulting COMPANY PRESENTATION “We provide practical knowledge and practical skills.” Internet: www.qsatis.com E-mail: ales@qsatis.com

2. Our mission • “We provide people and organisations with practical knowledge and skills to increase their posibilities to reach excellence of their products, services and relationships.”

3. We strive for … • Excellence of our… • People • Services (education, consulting) • Relations with customers • Contentment of… • Our customers • Our employees • Our cooperators • Confidence of our customers in … • Our services

4. From mission to action • We provide our customers with: • Consulting services • Training programs • On-site workshops • Our goal is • Regulatory complience (cGMP, cGLP, ISO 9001) • To solve problems (compliance, analytical) • Improved performance of personnel. • Our services are: • Expert • User friendly and interesting

5. Experiences • 15 years experience in the pharmaceutical industry (LEK) • Head of the chromatographic laboratory • Surviving FDA inspections • Development of HPLC methods • Responsible for transfering methods: • from R&D or partner companies to QC • from LEK to partner companies • Responsible for GMP in QC • Validation: Analytical equipment, Analytical methods • Training of personnel • Documentation System

6. Experiences • From 2003 independent consultant with Q-SATIS • Seminars, workshops, consultations • Pharmaceutical companies (LEK, KRKA), govermental laboratories, chemical industry, … • ISO 9001: 2000 expert cooperator for SIQ • Practising Open Space Technology • Working with colleagues • From LEK for GMP and analytics • Independant experts for ISO 9001:2000 • Practitioners of Open Space Technology

7. Field of work • GMP for laboratories and GLP • Analytical Services • Laboratory Efficacy • Analytical Equipment Purchase Assistence • Personaldevelopment

8. GMP UNRELIABLE RESULT GMP for laboratories and GLP • Analytical equipment validation • Risk/impact assesment (Compliance/Costs relationship) • Validation documentation • Analytical method validation

9. GMP for laboratories and GLP • Documentation System • Documentation Control: document generation – rewiew-approval-distribution-use-revision-retention/destruction) • Functional Documents (SOPs, specifications, analytical procedures) • How to make useful and efficient documents? • Records and reports: recordkeeping techniques • Out of Specification (OOS) Results

10. GMP for laboratories and GLP • Work flow in laboratory (sample-analysis-result-analytical certificates-keeping and archiving of data) • Chemicals, solvents management • Reference material management (standards) • Training of personnel • Change control system

11. Analytical Services • HPLC • Method development • Method validation • Method improvement: higher efficiency, reduced costs • GMP of Chromatography Data System • HPLC troublepreventing and troubleshooting

12. Analytical Services • HPLC • Method development • Method validation • Method improvement: higher efficiency, reduced costs • GMP of Chromatography Data System • HPLC troublepreventing and troubleshooting

13. Analytical Services • Dissolution Testing System • How to perform dissolution testing according to GMP • Validation of dissolution apparatus

14. Laboratory Efficacy • How to manage the laboratory? • How to measure laboratory efficacy? • Project work and teamwork in laboratory • Motivating laboratory personnel

15. IDEA USER SPECIFICATION NEGOTIATIONS AGREEMENT DESIGN QUALIFICATION PURCHASE Analytical Equipment Purchase Assistence • How to buy useful and GMP complient analytical instruments? • How to implement user specification in purchasing process?

16. Personal development • Seminars • Leading and managing myself (time management) • How to delegate to your people (for managers)? • Individual work

17. GMP, GLP generally says: • Define what do you want to do (=document) • Show that what will you do is “suitable for intended purpuse” (= do research, validate) • Do what you have said you will do (= be consistent with your documents) • Record what you do (=record and keep records) • Take actions if anything goes wrong (=do investigations) • Show that your products meet the highest standards of safety, identity, strength, purity and quality (=convince auditor)

18. Q-SATIS’s philosophy is: • Not just to make dokuments, but also put what is documented in real life. • We consider what you have already done • We consider your possibilities • Personnel, time, other resources • We believe in process • Step by step • Teamwork • 2-3 competent people from organisation

19. How do we work? • Audit of the GMP system in organisation • Whole laboratory • Individual system in laboratory (e.g. Validation of analytical equipment) • Analysis of the problem • Work with the team • Team can make documents • We can make documents (in English) • Implementation in the laboratory • Training of personnel • Audit after implementation

20. Expected results • GMP complient laboratory • Ensuring reliable analytical results • Passed GMP audits • Higher efficiency of the laboratory • Good relationship: reliable analytical results/resources

21. Conclusion • Q-SATIS: • GMP, GLP and laboratory experiences • Reliable partner • GMP in laboratory, GLP, • Analytical services, • Analytical equipment purchase assistence, • Laboratory Efficacy. • So, let’s start …