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Quality Management and Compliance in the Pharmaceutical and Related Industries

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Overview / Abstract:

Who Should Attend?
This intensive course will benefit those who need to understand the responsibilities and functions of the Quality Unit in a pharmaceutical firm and how the quality organization impacts all areas of operations and works as a team to help assure the quality of the products and compliance to regulations within in the pharmaceutical manufacturing arenas and related products. This material is particularly suitable for chemists, pharmacists, engineers and administrators working in the following areas:

• Research & Development
• Process Development
• Analytical Development
• Quality Assurance
• Quality Control
• Regulatory Affairs
• Plant Operations
• Purchasing
• Engineering/Maintenance
• Corporate/Plant Management

The course will also benefit personnel who are suppliers to the industry.

Course Description
This 2-day intensive course provides the basic principles and practices of Quality Assurance, Quality Management, Quality Control and use of robust Quality Systems in the pharmaceutical industry. The presented material also applies to the biopharmaceutical, diagnostic, device and cosmetic industries and to suppliers, including API manufacturers. Discussions will include the role of quality, major elements of pharmaceutical quality, the impact of management practices, the features of an effective quality organization, quality management throughout the product life cycle, and the role of corporate quality. This course discusses current quality issues including company reorganizations, outsourcing, the evolution of FDA approaches, global standards and the use of such techniques as Risk Management, Quality-by-Design and the Quality System approach. The course is presented in an open, interactive manner, encouraging discussion throughout.


Jun 20, 2018


Education (Higher Ed)


Live / Seminar, Seminar



Credits / Hours

1.2 CEUs



Presenters / Authors / Faculty

Bettina Kaplan; President, BKK Consulting

Keywords / Search Terms

CfPA Quality Management, Compliance, Pharmaceutical, GMPs, Risk Management, Quality-by-Design, Quality System, SOPs, FDA Seminar CE CME

LIVE Activity Location Details

06-19-2018 - 06-20-2018

New Brunswick
United States of America

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