| 作者简介：DAVID M. BLIESNER, PhD, is the founder and President of Delphi Analytical Services, Inc., an organization dedicated to improving clients' level of compliance with Current Good Manufacturing Practices, Quality System Regulations, and Current Good Clinical Practice Regulations by providing training technology, training, and compliance products and services. Dr. Bliesner also offers lectures, short courses, and hands-on training on compliance issues for analytical laboratories. He is the author of Establishing a CGMP Laboratory Audit System, also available from Wiley. |
| PREFACE 1. OVERVIEW OF METHODS VALIDATION 2. COMPONENTS OF METHODS VALIDATION 3. STEP 1: METHOD EVALUATION AND FURTHER DEVELOPMENT 4. STEP 2: FINAL METHOD DEVELOPMENT AND TRIAL METHODS VALIDATION 5. STEP 3: FORMAL METHODS VALIDATION AND REPORT GENERATION 6. STEP 4: FORMAL DATA REVIEW AND REPORT ISSUANCE 7. SUMMARY APPENDICES Ⅰ. GLOSSARY OF METHODS VALIDATION TERMS Ⅱ. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION STANDARD OPERATING PROCEDURE (SOP) Ⅲ. TEMPLATE FOR AN EXAMPLE END-USER REQUIREMENTS QUESTIONNAIRE Ⅳ. TEMPLATE FOR AN EXAMPLE METHOD REVIEW CHECKLIST Ⅴ. TEMPLATE FOR AN EXAMPLE STANDARD TEST METHOD Ⅵ. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION PROTOCOL Ⅶ. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION REPORT REFERENCES INDEX |
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