COURSE ID 224

Quality Management and Compliance in the Pharmaceutical and Related Industries

AVAILABLE Live
Date(s) and Time:
May 13, 2024 - May 15, 2024
12:30pm EDT - 5:00pm EDT
Duration: 12 Hours

Can't attend the live course?
Select the on-demand option during registration, and we will automatically send you the recording when it is ready.

Course Instructor

Joseph A. Albanese, Ph.D.

Beverly Barnwell

Early-Bird Offer

Limited Availability until April 23, 2024

$ 2130
Price
$ 2330
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

Under the global regulator-based inspection approach, the Quality system is one that is routinely audited. Quality issues are a huge factor in inspection observations leading to recalls for drugs, biologics, and medical devices. This indicates that not all companies are meeting current GMP expectations. Clearly a better understanding is needed to overcome this trend and ensure compliance for your company.

This intensive accredited training provides the basic principles and practices of Quality Assurance, Quality Management, Quality Control, and use of robust Quality Systems in the pharmaceutical industry. The course is presented in an open, interactive manner, encouraging discussion throughout. The material also applies to the bio/pharmaceutical, diagnostic, and medical device industries.

This introductory course would be beneficial to excipient and API suppliers. 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 outsourcing, the evolution of global regulatory approaches, global standards, and the use of such techniques as Risk Management, Quality-by-Design and the Quality System approach.

Upon completion of this course, you will be able to:

  • Explain how and why regulatory laws were enacted and how this evolved to global ICH guidance documents to define cGMPs expectations
  • Identify what fundamental components are needed to implement robust quality systems and processes within the quality assurance and control functions as well as other departments in the pharmaceutical and medical device industries to ensure compliance
  • Discuss how and why Management Review and Quality Risk Assessments are instrumental to maintaining a compliant organization, including contracted external manufacturers and laboratories.
  • Analyze current agency inspection trends to help stay abreast of the focus of compliance failures
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This introductory course will benefit those who need to understand the responsibilities and functions of the Quality Unit in a pharmaceutical firm. Participants will learn how the quality organization impacts all areas of operations and works as a team to help assure the quality of the products. In addition, the course highlights how to maintain compliance to regulations within the pharmaceutical manufacturing arenas and for supplier related materials or finished product.

This course is particularly suitable for chemists, pharmacists, engineers, and administrators working in the following areas:

  • Process Development
  • Analytical Development
  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • Plant Operations
  • Engineering/Maintenance
  • Corporate/Plant Management
  • Contract (External) Manufacturing
  • Supplier Quality
  • Purchasing

This course will also benefit personnel who manage these individuals as well as personnel who are suppliers to the industry.

 

Course Instructor

Joseph A. Albanese, Ph.D.

Managing Director of Albanese Consulting, LLC

Joseph A. Albanese, Ph.D.’s Courses

Beverly Barnwell

Independent Consultant

Beverly Barnwell’s Courses

Accreditation

Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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