Home > Collections > Topics in Quality Assurance for Pharmaceuticals
Topics in Quality Assurance for Pharmaceuticals
View PDF

Topics in Quality Assurance for Pharmaceuticals

Publisher: FX Conferences
  • 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).


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
Speakers: 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

Free Instant Access
This Month

Evidence-Based Medicine Reviews (EBMR) A definitive resource for electronic information in the evidence based medicine movement that combines the most trusted resources into a single, fully-searchable database.
Global Health The only specialist bibliographic abstracting and indexing database dedicated to public health and capturing key literature that is not covered by other databases.
Clinical Orthopaedics and Related Research® Original articles highlighting the latest in clinically relevant basic science of musculoskeletal diseases and their treatments.
Annals of Internal Medicine Published by the American College of Physicians, contains original articles, case reports, topical reviews, editorials, book reviews and medical notices for internal medicine.


Doody's Featured Books
Osborn's Brain: Imaging, Pathology, and Anatomy
Covers the must-know aspects of brain imaging together with spectacular pathology examples, relevant anatomy, and up-to-date techniques in neuroradiology.

Neurology Evidence: The Practice-Changing Studies
Synthesizes the vast body of literature available in neurology into one accessible, clinically relevant volume-features papers that have had the most impact on changing clinical practice.