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CURRICULUM VITAE
February 2020 Page 1 of 3
PERSONAL DATA Anne Sørensen (131268)
Elsdyrvej 18
4623 Lille Skensved
( 24 41 59 19
e-mail: [email protected]
PROFESSIONEL EXPERIENCE
2014
2010
2007
Oct.
Apr.
Feb.
Senior GxP Consultant, Pharmac ApS
Head of Production, Region Sjælland Sygehusapoteket (Region Zealand, Hospital Pharmacy)
Director, Quality Assurance. Qualified Person. Egalet a/s
2003 Jan. Director of Analysis and QA/QC and Qualified Person. Egalet a/s
2002 Feb. Manager of Analysis and QA/QC and Qualified Person. Egalet a/s
1997 Jan. Production Manager Non-sterile liquids at Leo Pharma.
1995 Jan. Head of section Tablet Production at Leo Pharma
1994 Oct. Pharmacist in Finished Product Packaging at Leo Pharma
1993 - 1994 Pharmacy Technician at Nærum Pharmacy
SENIOR GXP CONSULTANT, PHARMAC, MAIN EXPERIENCE 2019 Present Faglig ansvarlig farmaceut, private hospital pharmacy incl. FMT production in GMP faclilies
2019 Present Qualified Person/Quality Manager, certification of unlicensed medicine/investigational medicine
2018 2018 Qualified Person, sterile vial manufacturing, allergy immunotheraphy (7 months)
2017 Present Qualified Person, products manufactured outside Europe released in DK for the Nordic marked
2015 2016 Qualified Person, non-sterile pharmaceutical manufacturing
2014 - 2019 Head of Quality Assurance/Quality Control, Cosmetics
In the period from 2014 to present I have held more than 40 audits of API and finished goods manufacturers including audits
of warehouses for API and finished goods besides several internal audits in Denmark and in Europe.
Additionally, I have done project based consultancy work within Quality Assurance for several pharmaceutical and cosmetic
companies including assistance in setting up a cannabis manufacturing facility.
COURSES / TRAINING 2020
2019
Feb.
Nov.
Cannabislovgivningen, Pharmakon a/s, Denmark
14th QP Forum, QP Association, München, Germany
CURRICULUM VITAE
February 2020 Page 2 of 3
2019
2018
2018
2017
2017
2017
2017
2017
2016
2016
2015
2015
2015
2014
2014
2013
2013
2013
2012
2012
2011
2011
2010
2009
2009
2009
2009
2008
2008
Nov.
Nov.
Mar.
Nov.
Sep.
Jul.
Jun.
May
Sep.
May
Dec.
Nov.
Feb.
Dec.
Nov.
Nov.
Jun.
Jan.
Nov.
Okt.
Nov.
Mar.
Mar.
Nov.
May
Feb.
Jan.
Nov.
Sep.
Cannabidiol i kosmetik, Kosmetik- og hygiejnebrancen, Denmark GMP latest news, Pharmakon a/s, Denmark
Introduction to ISO 13485 Medical Device, Denmark
GMP latest news, Pharmakon a/s, Denmark
Good Distribution Practice, Pharmakon a/s, Denmark
How to write an ASMF, Pharmalex Denmark
GMP Compliance Auditing, Key2Compliance, Copenhagen
Audit Trail, Stage One Computing, IFF, Symbion Denmark
Process validation, Pharmakon a/s, Denmark
Cleaning validation strategy, techniques and regulations, Key2Compliance, Copenhagen
Mettler Toledo GWP and minimumweighing training, Denmark
GMP latest news, Pharmakon a/s, Denmark
GMP in the laboratory, Mads Friis Sørensen, Pharmac at Riemann A/S Hillerød
ICH Q7 Compliance for APIs (including special session on APIs Manufactured by Cell
Culture/Fermentation, ECA, Berlin
GMP latest news, Pharmakon a/s, Denmark
GMP latest news, Pharmakon a/s, Denmark
Contamination Control in clean rooms, GMP requirements and industrial practice (EU and FDA),
Key2Compliance, Copenhagen
LEAN and Strategy Map, Lars Dyrby Johansen, Management Consultant - Valcon
Strategic communication and Culture development, Region Zealand, Denmark
Introduction to Quality Risk Management jf. EU GMP Vol IV Part III, Hjorth Kvalitetsudvikling, Denmark
Manufacturing and Validation of Sterile Drugs, Pharmakon a/s, Denmark
Support for the process of change - a leadership development for managers in Region Zealand
(3x2 days)
Hands on Risk Assesment with Case Studies. IFF. Symbion Denmark
Workshop on An Incremental Approach to GMP from early to late phase Product Development
including Responsibility for Release of Clinical Batches. IFF. Symbion Denmark
Workshop CAPA, IFF and Karen Ginsbury, Symbion Denmark
Change Control Management, IFF and Karen Ginsbury, Symbion Denmark
GMP – trends, IFF and David Begg Associates, Symbion Denmark
Recommendations on how to apply ICH Q8/Q9/Q10 during audits, Key2Compliance, Copenhagen
Validation and Qualification Compliance Requirements, Key2Compliance, Copenhagen
2007 Nov. Management of clinical trials - GMP meets GCP, ECA, Berlin
2007 Oct. ICH Quality Guidelines Q1-10 an overview, Pharmakon a/s, Denmark
2007 May Practical Approaches to Global GMP for Investigational Medicinal Products, Key2Compliance,
Stockholm, Sweden
2005 May Role of the European Qualified Person, IIR, London
2005 Mar. The Mechanics of Preparing INDS & NDAS & FDA Regulations, The center for Professionel
Advancement, Amsterdam
CURRICULUM VITAE
February 2020 Page 3 of 3
SCIENTIFIC CONFERENCES/WORKSHOPS 2014
2012
2009
2009
2009
2009
2008
2006
Mar.
Mar.
May
May
Feb.
Jan.
May
Apr.
EAHP Congress (European Association Hospital Pharmacists), Barcelona
EAHP Congress (European Association Hospital Pharmacists), Milan
Speaker presentation ISPE Baseline Guideline Vol. 12 and FDA Process Validation, IFF Copenhagen
Speaker presentation ASTM E2500 standard, Risk based Verification, IFF Copenhagen
Workshop Change Control/Management, IFF Copenhagen
Workshop GMP-trends, IFF Copenhagen
Workshop CAPA, IFF Copenhagen
Integrating Development and Manufacturing, ISPE Copenhagen conference
2004 Oct. 4th Annual Life Science Symposium, Process Analytical Technology, Copenhagen
2003 Dec. Information Day, Danish Medicine Agency
2003 Nov. ISPE Nordic Annual Meeting, Copenhagen
2002 Sep. Inspectorate Information Day, IMB, Ireland