Course Description

Conducting Effective Quality Audits

October 30-November 1, 2018
New Brunswick, NJ

Course Offering 181030NJ1681
Course ID 1681

In-Person Course

Who Should Attend?
This overview course is designed for those who have recently been involved, or expect to be involved in internal or external audits.

The program will benefit individuals in the pharmaceutical and related industries, such as medical device, diagnostics, cosmetics, food, biotechnology as well as vendors, suppliers and contract organizations.

The course can be of interest to top management responsible for audit programs in their companies as well as to professionals in a variety of functions such as:
  • QA & QC
  • Laboratory
  • R & D
  • Production
  • Regulatory
  • Toxicology
  • Documentation Management
  • Clinical Research
  • Packaging
  • Purchasing

Course Description
Auditing is a powerful management tool in establishing how effectively a company controls the quality of its products and ensures compliance.

This hands-on, practical course will deal primarily with auditing tools and techniques which are applicable to any industry or function. A quick overview of requirements for an audit program in pre-clinical and clinical operations will be provided. Specific examples will cover auditing certain aspects of drug and medical device operations for compliance with cGMP.

The course will consist of lectures, discussions, exercises, workshops and a role-playing session involving a simulated compliance audit.

Course Director
Renée B. Galkin; Quality Management Consultant

Renée B. Galkin is a quality management consultant with over 30 years experience in the pharmaceutical and device industries.

Prior to starting her consulting business, Ms. Galkin was part of two major companies: Science Management Corporation – a multinational consulting firm and then Wyeth/Pfizer where she gained her pharmaceutical experience during her 20 year association. Throughout her career Ms. Galkin held both domestic and international assignments.

Ms. Galkin has an MBA in Business Management from New York University, an MA in Education and Science from Brown University and a Bachelor of Science in Biology from Northeastern University. She is a member of the American Society for Quality, the Parenteral Drug Association and the International Society for Pharmaceutical Engineering (ISPE). She is also a Certified Quality Auditor.

As a consultant, Ms. Galkin has been providing training and consulting advice to pharmaceutical and medical device companies in the United States and Europe in areas related to consent decrees, pre-approval and regular FDA inspections, audit programs, quality systems requirements, documentation systems management, validation, supplier selection and management.

She also directs several technical courses offered by the Center for Professional Advancement. Participants at her courses enjoy and appreciate her interactive and personal teaching style which keeps the audience alert and constantly involved.

Venue Information
venue
The Heldrich Hotel
10 Livingston Avenue
New Brunswick , NJ 08901 US
Phone: 732-729-4670
Fax: 732-729-4672
Website: The Heldrich Hotel

PLEASE NOTE: Participants must make their own reservations; the cost of hotel accommodation is not included in the course fee. Final hotel information will be emailed to you in your confirmation package approximately 3 weeks prior to the course start date.