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The scope is limited to the requirements based on the US Food and Drug Administration (FDA) Regulations. This is an ideal book for auditors and auditees who want to obtain practical PV auditing skills to use within the BioTechnology/Pharmaceutical Industry in the USA.
The scope is limited to the requirements based on the US Food and Drug Administration (FDA) Regulations. This is an ideal book for auditors and auditees who want to obtain practical PV auditing skills to use within the BioTechnology/Pharmaceutical Industry in the USA.
Heather Murphy is a expert Pharmacovigilance (PV) professional with her focus in Pharmacovigilance Operations and PV Audits. For over 20 years she has established PV and reengineered PV departments for companies in various stages of development within the pharmacovigilance industry. As a result of her "hands on" experiences she has successfully developed PV systems for small-large size companies in preparation for US and global product launch. PV Operations activities have ranged from the strategic to tactical with extensive experience in PV inspections including the FDA, EMA, PMDA, AIFA, Health Canada, MHRA, ANSM, BfArM and Swiss Medic.
Current PV audit activities include audits for/of preinspection preparation, routine and for cause, vendor qualification, REMS, business partner, contract resource organizations (CROs), specialty pharmacies, warehouse vendors, supply vendors, and distribution vendors.
She is a Certified Quality Auditor (CQA) through the American Society of Quality, obtained a MBA from Suffolk University in Boston, MA, a Bachelor of Science in Nursing (BScN) from Dalhousie University in Nova Scotia, Canada and an RN from the Prince Edward Island School of Nursing in P.E.I Canada.
Chapter 1 Introduction.- Chapter 2 Audit Types.- Chapter 3 PV Audit Preparation.- Chapter 4 PV Audit Conduct.- Chapter 5 Audit Report.- Chapter 6 Dos and Don'ts of a successful audit.
| Erscheinungsjahr: | 2024 |
|---|---|
| Fachbereich: | Toxikologie |
| Genre: | Mathematik, Medizin, Naturwissenschaften, Technik |
| Rubrik: | Wissenschaften |
| Medium: | Buch |
| Inhalt: |
xii
146 S. |
| ISBN-13: | 9783031735950 |
| ISBN-10: | 3031735951 |
| Sprache: | Englisch |
| Einband: | Gebunden |
| Autor: | Murphy, Heather |
| Hersteller: |
Springer Nature Switzerland
Springer International Publishing AG |
| Verantwortliche Person für die EU: | Springer Verlag GmbH, Tiergartenstr. 17, D-69121 Heidelberg, juergen.hartmann@springer.com |
| Maße: | 241 x 160 x 15 mm |
| Von/Mit: | Heather Murphy |
| Erscheinungsdatum: | 08.11.2024 |
| Gewicht: | 0,41 kg |
Heather Murphy is a expert Pharmacovigilance (PV) professional with her focus in Pharmacovigilance Operations and PV Audits. For over 20 years she has established PV and reengineered PV departments for companies in various stages of development within the pharmacovigilance industry. As a result of her "hands on" experiences she has successfully developed PV systems for small-large size companies in preparation for US and global product launch. PV Operations activities have ranged from the strategic to tactical with extensive experience in PV inspections including the FDA, EMA, PMDA, AIFA, Health Canada, MHRA, ANSM, BfArM and Swiss Medic.
Current PV audit activities include audits for/of preinspection preparation, routine and for cause, vendor qualification, REMS, business partner, contract resource organizations (CROs), specialty pharmacies, warehouse vendors, supply vendors, and distribution vendors.
She is a Certified Quality Auditor (CQA) through the American Society of Quality, obtained a MBA from Suffolk University in Boston, MA, a Bachelor of Science in Nursing (BScN) from Dalhousie University in Nova Scotia, Canada and an RN from the Prince Edward Island School of Nursing in P.E.I Canada.
Chapter 1 Introduction.- Chapter 2 Audit Types.- Chapter 3 PV Audit Preparation.- Chapter 4 PV Audit Conduct.- Chapter 5 Audit Report.- Chapter 6 Dos and Don'ts of a successful audit.
| Erscheinungsjahr: | 2024 |
|---|---|
| Fachbereich: | Toxikologie |
| Genre: | Mathematik, Medizin, Naturwissenschaften, Technik |
| Rubrik: | Wissenschaften |
| Medium: | Buch |
| Inhalt: |
xii
146 S. |
| ISBN-13: | 9783031735950 |
| ISBN-10: | 3031735951 |
| Sprache: | Englisch |
| Einband: | Gebunden |
| Autor: | Murphy, Heather |
| Hersteller: |
Springer Nature Switzerland
Springer International Publishing AG |
| Verantwortliche Person für die EU: | Springer Verlag GmbH, Tiergartenstr. 17, D-69121 Heidelberg, juergen.hartmann@springer.com |
| Maße: | 241 x 160 x 15 mm |
| Von/Mit: | Heather Murphy |
| Erscheinungsdatum: | 08.11.2024 |
| Gewicht: | 0,41 kg |
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