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Description
Stay current on the ever-changing pharmaceutical regulatory environment with 10 audio recordings of industry experts offering practical guidance on quality assurance issues.
Ovid and FX Conferences offer thousands of professional development hours for your teams, conveniently packaged and delivered as a collection of audio recordings to save you time and money.
Topics in this collection have a global appeal and are relevant for multiple departments within your organization—R & D, Market Research, Compliance, and more. Each of the 10 recordings consists of a 45-minute, telephone-based presentation delivered by expert international speakers, followed by a 15-minute question-and-answer session (collection available with and without transcripts).
RECORDINGS:
1. Preparing for Upcoming Changes in EU Pharmacovigilance Requirements
Speaker: Dr. Jan Petracek, CEO & Chief Consultant, PharmInvent
2. Industry Update – Europe's New Pharmacovigilance Regulations
Speaker: Stefan Blesse, Principal Consultant, Granzer Regulatory Consulting & Services
3. How to Document and Implement an FDA-Ready CAPA System
Speaker: Mark Perkins, Principal Consultant, Medical Device QA/RA Consulting
4. Process Validation – Implementing the Finalized FDA Guidance
Speaker: Todd Arney, Principal Consultant, Technical & Quality Services, LLC
5. FDA’s Part 11 Inspections: How to Prepare Yourself to Prove Data Integrity
Speaker: John Avellanet, Managing Director & Principal, Cerulean Associates LLC
6. Using Practical Statistics to Interpret Stability Results
Speaker: Steven Walfish, President, Statistical Outsourcing Services
7. Driving Your Quality System With Effective Management Controls
Speaker: Vinny Sastri, President, Winovia LLC
8. Responding to Audit Recommendations and Observations Without Confrontation or Frustration
Speaker: Thomas J Purcell, Principal, Urtech Medical Writing & Consultancy, LLC
9. 7 Critical FDA Expectations of Senior Management
Speaker: John Avellanet, Managing Director & Principal, Cerulean Associates LLC
10. Developing Effective Quality Agreements: Legal and Regulatory Issues
Speaker: Alan Minsk, Partner, Arnall Golden Gregory LLP
Ovid and FX Conferences offer thousands of professional development hours for your teams, conveniently packaged and delivered as a collection of audio recordings to save you time and money.
Topics in this collection have a global appeal and are relevant for multiple departments within your organization—R & D, Market Research, Compliance, and more. Each of the 10 recordings consists of a 45-minute, telephone-based presentation delivered by expert international speakers, followed by a 15-minute question-and-answer session (collection available with and without transcripts).
RECORDINGS:
1. Preparing for Upcoming Changes in EU Pharmacovigilance Requirements
Speaker: Dr. Jan Petracek, CEO & Chief Consultant, PharmInvent
2. Industry Update – Europe's New Pharmacovigilance Regulations
Speaker: Stefan Blesse, Principal Consultant, Granzer Regulatory Consulting & Services
3. How to Document and Implement an FDA-Ready CAPA System
Speaker: Mark Perkins, Principal Consultant, Medical Device QA/RA Consulting
4. Process Validation – Implementing the Finalized FDA Guidance
Speaker: Todd Arney, Principal Consultant, Technical & Quality Services, LLC
5. FDA’s Part 11 Inspections: How to Prepare Yourself to Prove Data Integrity
Speaker: John Avellanet, Managing Director & Principal, Cerulean Associates LLC
6. Using Practical Statistics to Interpret Stability Results
Speaker: Steven Walfish, President, Statistical Outsourcing Services
7. Driving Your Quality System With Effective Management Controls
Speaker: Vinny Sastri, President, Winovia LLC
8. Responding to Audit Recommendations and Observations Without Confrontation or Frustration
Speaker: Thomas J Purcell, Principal, Urtech Medical Writing & Consultancy, LLC
9. 7 Critical FDA Expectations of Senior Management
Speaker: John Avellanet, Managing Director & Principal, Cerulean Associates LLC
10. Developing Effective Quality Agreements: Legal and Regulatory Issues
Speaker: Alan Minsk, Partner, Arnall Golden Gregory LLP
Details
- Product Type:
- Collection
- Author:
- NA
- Specialty:
-
- Pharmaceutical Science
- Language:
- English
- Update Frequency:
- Annually