Workshop Details

Dates

June 14, 2024

Time

9:30 am – 3:30 pm

Cost

CAD $595.00 + HST

Location

Online

Deadline

June 7, 2024

Workshop Overview

This comprehensive workshop delves into the intricate world of Cleaning Validation in the pharmaceutical industry. The entire Cleaning Validation Program will be comprehensively examined, from Cleaning Process development to ongoing monitoring to ensure effectiveness.

Led by a seasoned professional, the workshop will also provide hands-on training in a GMP laboratory setting. Students will participate in a realistic Cleaning Validation sample analysis by HPLC. Results will be calculated and compared to typical specification limits. This will allow students to experience typical testing performed in the pharmaceutical industry and develop a deeper understanding of Cleaning Validation.

Upon completion of this workshop at AAPS, graduates emerge with a profound understanding of Cleaning Validation and its applications, positioning them for success in the dynamic landscape of pharmaceutical drug manufacturing and analysis.

Who Should Attend​

This workshop caters specifically to professionals deeply engaged in Quality Control (QC) and Laboratory operations within the pharmaceutical and allied industries. It is tailored for QC analysts, laboratory technicians, managers, and quality assurance personnel who play pivotal roles in ensuring product quality and adherence to regulatory standards.

For those involved in regulatory compliance, method validation, instrument calibration, and documentation within QC and laboratory settings, this workshop offers a comprehensive understanding of HPLC systems and methodologies. Whether you’re conducting analytical testing, overseeing laboratory processes, or managing quality control procedures, the insights gained from this workshop are invaluable.

By attending this workshop, participants deepen their expertise in HPLC methodology and regulatory compliance, empowering them to excel in their roles within Quality Control and Laboratory operations.

Workshop Outline

This workshop covers the following topics:

  • Background of Cleaning Validation
  • Regulations and Guidelines
  • Cleaning Validation Program
  • Cleaning Validation Evaluation
  • Cleaning Master Plan/Strategies
  • Cleaning Plans
  • Procedures and Documentation
  • Tips for Quality Assurance Reviewers

Learning Outcomes

Regulatory Expectations and Compliance:

Acquire a comprehensive understanding of Health Canada and FDA expectations from a compliance perspective. Actual FDA inspection observations (“483” letters) and Warning Letters will be reviewed and discussed to illustrate the importance of Cleaning Validation.

Sampling Techniques and Analysis:

Develop insight into the evaluation of Cleaning Validation effectiveness through hands-on sample preparation and HPLC analysis in our GMP lab.

Method Implementation and Troubleshooting:

Hone your ability to audit all aspects of Cleaning Validation with tips especially created for Quality Assurance reviewers.

All participants will receive a certificate of attendance upon completion of the workshop.

Note: Registration for this workshop is now closed. For more information on our upcoming workshops, please contact us at info@aaps.ca.

Cleaning Validation in the Pharmaceutical Industry

June 14, 2024

Other Workshops Available

Kevin Mueller

Pharma, Cannabis

Kevin has over 25 years of pharmaceutical industry experience working for Novopharm Ltd. and Teva Canada Ltd. For 19 years, he was a supervisor in the following areas: Analytical Research and Development Stability, Quality Control Finished Product, Quality Control Stability, Quality Control Method Transfer, and Operational Excellence. Kevin is known as a positive person with an ability to motivate and guide people to reach their potential. He has demonstrated expertise in compliance, data integrity, laboratory investigations, root cause problem solving, recommending and implementing corrective and preventative actions (CAPAs), and continuous improvement of documentation and efficiency.

Kevin graduated from the University of Western Ontario with a M.Sc. in chemistry and has a yellow belt in Operational Excellence. In his spare time, Kevin enjoys long distance running.