ComplianceOnline

Implementing a Modern Pharmaceutical Quality System

Instructor: Steven Laurenz
Product ID: 705055
Training Level: Beginning to Advanced
  • Duration: 60 Min
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This presentation explores the basic concepts making up an ICH Q10 Quality System approach and steps to properly implement the concepts.

Why Should You Attend:

In 2008, the International Conference on Harmonization published the ICH tripartite guideline titled, Pharmaceutical Quality System Q10. The guideline describes a model for an effective pharmaceutical quality system. As quoted in the document, “ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Standards Organization (ISO) quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations, and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”. But the question becomes: How does a business culture implement these principles effectively and efficiently.

This presentation explores the basic concepts making up an ICH Q10 Quality System approach and steps to properly implement the concepts.

Learning Objectives:

  • Prepare individuals to better understand the principles behind implementing the principles of a modern Quality System as outlined in the ICHQ10 guidance.
  • Define what is meant by a modern Pharmaceutical Quality System
  • Explain the benefits of implementing a more modern Pharmaceutical Quality System
  • Review the key concepts covered in the ICH Q10 guidance
  • What are some of the key struggles experienced implementing these principles
  • Review methods to properly implement the ICH10 principles

Areas Covered in the Webinar:

Key principles discussed include

  • What is Quality System and what is meant about a modern Quality System?
  • What are the key principles making up the ICH Q10 guideline?
  • What are some of the key struggles to implement a more modern Pharmaceutical Quality System Approach?
  • Concepts to implement the ICH Q10 principles

Who Will Benefit:

This course is designed for people tasked with developing, filing, and manufacturing pharmaceutical products especially small molecule oral dosage forms. This includes individuals that have responsibilities for formulation development, scale-up, filing, and commercial manufacture of dosage forms as well as maintaining the high quality of those products. Following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Development professionals
  • Senior development managers
Instructor Profile:
Steven Laurenz

Steven Laurenz
Principal Consultant, BioPhia Consulting Inc

Steven Laurenz has over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. He is skilled in taking new products from early laboratory stage to successful manufacturing launch. He is an expert in integrating Quality by Design and risk management into product development. He has proven experience in establishing a Quality System for a R&D Quality Assurance organization.

Steven has headed product development departments at Abbott Laboratories and AbbVie Inc. and held leadership positions in numerous technical consortium.

Steven Laurenz holds an M.S. in Chemical Engineering from the Michigan State University

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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