Loading Events

« All Events

  • This event has passed.

Cleaning Validation in the Pharmaceutical Industry Workshop

April 18 @ 8:00 am - 5:00 pm

Cleaning Validation in the Pharmaceutical Industry Workshop

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.

Webinar 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.

Certificate of Attendance and Course Material

  • • All participants will receive a certificate of attendance upon completion of the workshop.
  • The participants will be receiving specially prepared course manual.

Details

Date:
April 18
Time:
8:00 am - 5:00 pm