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의약품 Special Topics related to cGMP 사이버교육

의약품 Special Topics related to cGMP 사이버교육 : 작성자, 작성일, 조회수, 원문,출처, 정보 제공
작성자	관리자
작성일	2012-01-24	조회수	1,174
원문	식품의약품안전처
출처	http://helpdrug.kfda.go.kr/GMP/GMP_the/start.html

교육내용

1. Sterilization Processes & F, D, Z Values I

2. Sterilization Processes & F, D, Z Values II

3. Hazard & Risk Analysis in Pharmaceutical Products

4. Environmental Monitoring

5. cGMP for Cell & Gene Therapy Products I

6. cGMP for Cell & Gene Therapy Products II

7. Biosafety Regulation I

8. Biosafety Regulation II

9. GLP for Nonclinical Lab. Studies I

10. GLP for Nonclinical Lab. Studies II

11. FDA’s GLP Inspections

12. The Characterization of Cell Lines Used to Produce Biologicals_I

13. The Characterization of Cell Lines Used to Produce Biologicals_II

14. Lot Release and Its Alternatives for Biological Products

15. Quality System Approach to Pharmaceutical cGMP I

16. Quality System Approach to Pharmaceutical cGMP II

17. Quality System Approach to Pharmaceutical cGMP III

18. FDA System-based Inspection for Drugs Biologics_I

19. FDA System-based Inspection for Drugs/Biologics II

20. Process Analytical Technology_I

21. Process Analytical Technology_II

※ 자세한 내용은 아래 원문 URL을 이용하시기 바랍니다.

이전글 의약품 Validation 사이버교육
다음글 비임상시험관리기준(GLP) 사이버교육

<p><span style="color: #000000;"><strong>교육내용</strong></span><br /><br /><br /></p>
<p class="바탕글"><span style="color: #000000;">1. Sterilization Processes & F, D, Z Values I</span><br /><br /><span style="color: #000000;">2. Sterilization Processes & F, D, Z Values II</span><br /><br /><span style="color: #000000;">3. Hazard & Risk Analysis in Pharmaceutical Products</span><br /><br /><span style="color: #000000;">4. Environmental Monitoring</span><br /><br /><span style="color: #000000;">5. cGMP for Cell & Gene Therapy Products I</span><br /><br /><span style="color: #000000;">6. cGMP for Cell & Gene Therapy Products II</span><br /><br /><span style="color: #000000;">7. Biosafety Regulation I</span><br /><br /><span style="color: #000000;">8. Biosafety Regulation II</span><br /><br /><span style="color: #000000;">9. GLP for Nonclinical Lab. Studies I</span><br /><br /><span style="color: #000000;">10. GLP for Nonclinical Lab. Studies II</span><br /><br /><span style="color: #000000;">11. FDA’s GLP Inspections</span><br /><br /><span style="color: #000000;">12. The Characterization of Cell Lines Used to Produce Biologicals_I</span><br /><br /><span style="color: #000000;">13. The Characterization of Cell Lines Used to Produce Biologicals_II</span><br /><br /><span style="color: #000000;">14. Lot Release and Its Alternatives for Biological Products</span><br /><br /><span style="color: #000000;">15. Quality System Approach to Pharmaceutical cGMP I</span><br /><br /><span style="color: #000000;">16. Quality System Approach to Pharmaceutical cGMP II</span><br /><br /><span style="color: #000000;">17. Quality System Approach to Pharmaceutical cGMP III</span><br /><br /><span style="color: #000000;">18. FDA System-based Inspection for Drugs Biologics_I</span><br /><br /><span style="color: #000000;">19. FDA System-based Inspection for Drugs/Biologics II</span><br /><br /><span style="color: #000000;">20. Process Analytical Technology_I</span><br /><br /><span style="color: #000000;">21. Process Analytical Technology_II</span><br /><span style="font-family: 굴림, gulim;"><span style="color: #0000ff; font-weight: bold;"><br /><br /><br /><br />※ 자세한 내용은 아래 </span><span style="color: #ff0000; font-weight: bold;">원문 URL</span><span style="color: #0000ff; font-weight: bold;">을 이용하시기 바랍니다.</span></span></p>
<p class="바탕글"><span style="font-family: 굴림, gulim;"> </span></p>

<p><span style="color: #000000;"><strong>교육내용</strong></span><br /><br /><br /></p> <p class="바탕글"><span style="color: #000000;">1. Sterilization Processes & F, D, Z Values I</span><br /><br /><span style="color: #000000;">2. Sterilization Processes & F, D, Z Values II</span><br /><br /><span style="color: #000000;">3. Hazard & Risk Analysis in Pharmaceutical Products</span><br /><br /><span style="color: #000000;">4. Environmental Monitoring</span><br /><br /><span style="color: #000000;">5. cGMP for Cell & Gene Therapy Products I</span><br /><br /><span style="color: #000000;">6. cGMP for Cell & Gene Therapy Products II</span><br /><br /><span style="color: #000000;">7. Biosafety Regulation I</span><br /><br /><span style="color: #000000;">8. Biosafety Regulation II</span><br /><br /><span style="color: #000000;">9. GLP for Nonclinical Lab. Studies I</span><br /><br /><span style="color: #000000;">10. GLP for Nonclinical Lab. Studies II</span><br /><br /><span style="color: #000000;">11. FDA’s GLP Inspections</span><br /><br /><span style="color: #000000;">12. The Characterization of Cell Lines Used to Produce Biologicals_I</span><br /><br /><span style="color: #000000;">13. The Characterization of Cell Lines Used to Produce Biologicals_II</span><br /><br /><span style="color: #000000;">14. Lot Release and Its Alternatives for Biological Products</span><br /><br /><span style="color: #000000;">15. Quality System Approach to Pharmaceutical cGMP I</span><br /><br /><span style="color: #000000;">16. Quality System Approach to Pharmaceutical cGMP II</span><br /><br /><span style="color: #000000;">17. Quality System Approach to Pharmaceutical cGMP III</span><br /><br /><span style="color: #000000;">18. FDA System-based Inspection for Drugs Biologics_I</span><br /><br /><span style="color: #000000;">19. FDA System-based Inspection for Drugs/Biologics II</span><br /><br /><span style="color: #000000;">20. Process Analytical Technology_I</span><br /><br /><span style="color: #000000;">21. Process Analytical Technology_II</span><br /><span style="font-family: 굴림, gulim;"><span style="color: #0000ff; font-weight: bold;"><br /><br /><br /><br />※ 자세한 내용은 아래 </span><span style="color: #ff0000; font-weight: bold;">원문 URL</span><span style="color: #0000ff; font-weight: bold;">을 이용하시기 바랍니다.</span></span></p> <p class="바탕글"><span style="font-family: 굴림, gulim;"> </span></p>
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