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).

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
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

JOTM
Embase® The Embase database is the most trusted source of global, evidence-based pharmacological and biomedical research with over 30 million bibliographic records dating back to 1947.
JOTM
Visible Body Heart & Circulatory Premium This interactive 3D Atlas is a deep dive into the heart and circulatory system for learning, reference, and patient education.
JOTM
Circulation Research Presents peer-reviewed reports on research advances in biology, biochemistry, biophysics, cellular and molecular biology, morphology, pathology, physiology, and pharmacology.
JOTM
Regional Anesthesia & Pain Medicine Publishes peer-reviewed scientific and clinical studies to advance the understanding and application of regional techniques for surgical anesthesia and postoperative analgesia.

Noteworthy

Doody's Featured Books
Manual of Valvular Heart Disease
Portable and clinically oriented, this full-color handbook is a unique and timely guide to valvular heart disease and percutaneous coronary interventions.

Khonsari's Cardiac Surgery: Safeguards and Pitfalls in Operative Technique
Details the most important techniques in a concise, readable, and richly illustrated format, with a focus on avoiding and managing surgical pitfalls and complications.