1 BulkGMPCircle 2017 04 21 ISPE 2017 Europe
![제 1차 Bulk(원료)-GMP-Circle 회의 2017. 04. 21. (금) 제 1차 Bulk(원료)-GMP-Circle 회의 2017. 04. 21. (금)](https://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-1.jpg)
제 1차 Bulk(원료)-GMP-Circle 회의 2017. 04. 21. (금)
![ISPE 2017 Europe Annual conference 3 -5 April 2017 Barocelona, Spain Sep. 2017 ISPE 2017 Europe Annual conference 3 -5 April 2017 Barocelona, Spain Sep. 2017](http://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-2.jpg)
ISPE 2017 Europe Annual conference 3 -5 April 2017 Barocelona, Spain Sep. 2017
![1. ISPE 2017 Europe Annual conference 2. EU GMP Annex 1 3. Data integrity 1. ISPE 2017 Europe Annual conference 2. EU GMP Annex 1 3. Data integrity](http://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-3.jpg)
1. ISPE 2017 Europe Annual conference 2. EU GMP Annex 1 3. Data integrity
![Track 1 Track 2 Ø Factories of the Future Ø Innovation Ø Serialisation Ø Track 1 Track 2 Ø Factories of the Future Ø Innovation Ø Serialisation Ø](http://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-4.jpg)
Track 1 Track 2 Ø Factories of the Future Ø Innovation Ø Serialisation Ø Advanced Aseptic Processing Track 3 Track 4 Ø Clinical and ATMP Supply chain Ø Data integrity and GAMP Ø GDP & GMP Annex 15 Risk Manag… Ø Patient Centricity and innovation supp. . Paperless…
![2. EU GMP Annex 1 2. EU GMP Annex 1](http://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-5.jpg)
2. EU GMP Annex 1
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![Particle counter: ISO 21501 -4 Particle counter: ISO 21501 -4](http://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-8.jpg)
Particle counter: ISO 21501 -4
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![3. Data Integrity 3. Data Integrity](http://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-13.jpg)
3. Data Integrity
![Dr. Nuala Calnan, Pharmaceutical Regulatory Science Team , Dublin Institute of Technology, Ireland Barocelona Dr. Nuala Calnan, Pharmaceutical Regulatory Science Team , Dublin Institute of Technology, Ireland Barocelona](http://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-14.jpg)
Dr. Nuala Calnan, Pharmaceutical Regulatory Science Team , Dublin Institute of Technology, Ireland Barocelona 5 th April 2017 Brian Ducan Vice President, Engagement Operations, Quality Executive Partners, Inc. Barocelona 5 th April 2017
![Chris Clark Director & Principal consultant , Ten consulting Limited, 2017 EU conference, Barocelona Chris Clark Director & Principal consultant , Ten consulting Limited, 2017 EU conference, Barocelona](http://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-15.jpg)
Chris Clark Director & Principal consultant , Ten consulting Limited, 2017 EU conference, Barocelona 4 -5 April, 2017
![Dr. Nuala Calnan, Pharmaceutical Regulatory Science Team , Dublin Institute of Technology, Ireland Barocelona Dr. Nuala Calnan, Pharmaceutical Regulatory Science Team , Dublin Institute of Technology, Ireland Barocelona](http://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-16.jpg)
Dr. Nuala Calnan, Pharmaceutical Regulatory Science Team , Dublin Institute of Technology, Ireland Barocelona 5 th April 2017
![Dr. Nuala Calnan, Pharmaceutical Regulatory Science Team , Dublin Institute of Technology, Ireland Barocelona Dr. Nuala Calnan, Pharmaceutical Regulatory Science Team , Dublin Institute of Technology, Ireland Barocelona](http://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-17.jpg)
Dr. Nuala Calnan, Pharmaceutical Regulatory Science Team , Dublin Institute of Technology, Ireland Barocelona 5 th April 2017
![David churchward Expert GMP inspector, MHRA Barocelona 5 th April 2017 David churchward Expert GMP inspector, MHRA Barocelona 5 th April 2017](http://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-18.jpg)
David churchward Expert GMP inspector, MHRA Barocelona 5 th April 2017
![Brian Ducan Vice President, Engagement Operations, Quality Executive Partners, Inc. Barocelona 5 th April Brian Ducan Vice President, Engagement Operations, Quality Executive Partners, Inc. Barocelona 5 th April](http://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-19.jpg)
Brian Ducan Vice President, Engagement Operations, Quality Executive Partners, Inc. Barocelona 5 th April 2017
![Brian Ducan Vice President, Engagement Operations, Quality Executive Partners, Inc. Barocelona 5 th April Brian Ducan Vice President, Engagement Operations, Quality Executive Partners, Inc. Barocelona 5 th April](http://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-20.jpg)
Brian Ducan Vice President, Engagement Operations, Quality Executive Partners, Inc. Barocelona 5 th April 2017
![Dr. Nuala Calnan, Pharmaceutical Regulatory Science Team , Dublin Institute of Technology, Ireland Barocelona Dr. Nuala Calnan, Pharmaceutical Regulatory Science Team , Dublin Institute of Technology, Ireland Barocelona](http://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-21.jpg)
Dr. Nuala Calnan, Pharmaceutical Regulatory Science Team , Dublin Institute of Technology, Ireland Barocelona 5 th April 2017
![Brian Ducan Vice President, Engagement Operations, Quality Executive Partners, Inc. Barocelona 5 th April Brian Ducan Vice President, Engagement Operations, Quality Executive Partners, Inc. Barocelona 5 th April](http://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-22.jpg)
Brian Ducan Vice President, Engagement Operations, Quality Executive Partners, Inc. Barocelona 5 th April 2017
![Dr. Nuala Calnan, Pharmaceutical Regulatory Science Team , Dublin Institute of Technology, Ireland Barocelona Dr. Nuala Calnan, Pharmaceutical Regulatory Science Team , Dublin Institute of Technology, Ireland Barocelona](http://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-23.jpg)
Dr. Nuala Calnan, Pharmaceutical Regulatory Science Team , Dublin Institute of Technology, Ireland Barocelona 5 th April 2017
![Chris Clark Director & Principal consultant, Ten consulting Limited Barocelona 5 th April 2017 Chris Clark Director & Principal consultant, Ten consulting Limited Barocelona 5 th April 2017](http://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-24.jpg)
Chris Clark Director & Principal consultant, Ten consulting Limited Barocelona 5 th April 2017
![David churchward Expert GMP inspector, MHRA Barocelona 5 th April 2017 David churchward Expert GMP inspector, MHRA Barocelona 5 th April 2017](http://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-25.jpg)
David churchward Expert GMP inspector, MHRA Barocelona 5 th April 2017
![David churchward Expert GMP inspector, MHRA Barocelona 5 th April 2017 David churchward Expert GMP inspector, MHRA Barocelona 5 th April 2017](http://slidetodoc.com/presentation_image_h2/82207c8ff36e1139ccb710aecf4a82ca/image-26.jpg)
David churchward Expert GMP inspector, MHRA Barocelona 5 th April 2017
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- Slides: 27