Book Online Tickets for How to Conduct Annual Product Reviews to, Palo Alto. 
How to Conduct Annual Product Reviews to Achieve GMP Compliance

 
 

This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regul

How to Conduct Annual Product Reviews to Achieve GMP Compliance

 

  • One Dial-in One Attendee

    Sale Date Ended

    USD 229
    Sold Out
  • Group-Max 10 Attendees or Location

    Sale Date Ended

    USD 599
    Sold Out
  • 1x Person - Unlimited viewing for 6 Months

    Sale Date Ended

    USD 299
    Sold Out
  • One CD or USB is for usage in one location only

    Sale Date Ended

    USD 399
    Sold Out
  • LIVE + RECORDED VERSION

    Sale Date Ended

    USD 399
    Sold Out
  • LIVE + TRAINING CD or USB

    Sale Date Ended

    USD 499
    Sold Out

Invite friends

Contact Us

Page Views : 1

About The Event

How to Conduct Annual Product Reviews to Achieve GMP Compliance

 
 
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.

Why Should You Attend:

Annual Product Quality Review (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change in the specifications of the product or any change in the manufacturing process. It is designed to minimize the product defects and also the risks associated with the manufacturing of the pharmaceutical product.

This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe. It will also discuss the comparative evaluation about similarities and differences of requirements associated with the manufacturing of the drug product in different countries. It is also necessary to know that the regulatory requirements of different countries are different and hence this will further guarantee the quality of the pharmaceutical product.

Learning Objectives:

  • Discuss how to write APRs
  • Outline the requirements for APR reporting
  • Review what information to include in the reports
  • Discuss how well written APRs benefit your firm’s compliance

Areas Covered in the Webinar:

This webinar will review:

  • Annual Product Review definition
  • What needs to be included in the report
  • A model of an example Annual Product Review Report
  • Review of citations

Who Will Benefit:

  • Site Quality Operations Managers
  • Quality Assurance personnel
  • Plant Managers and Supervisors
  • Manufacturing Superintendents and Managers
  • Regulatory Affairs Managers

Instructor Profile:

Danielle DeLucy

Danielle DeLucy
Owner, ASA Training and Consulting, LLC

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.

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.