Online Safety Community

Proper Execution of Annual Product Reviews

Event Details

Proper Execution of Annual Product Reviews

Time: February 13, 2018 from 1pm to 2pm
Location: Training Doyens 26468 E Walker Dr,Aurora, Colorado
City/Town: Aurora, Colorado 80016-6104
Website or Map: http://bit.ly/2D3WdKg
Phone: 7209961616
Event Type: webinar, :, life, science
Organized By: Training Doyens
Latest Activity: Jan 15

Export to Outlook or iCal (.ics)

Event Description

OVERVIEW

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.

WHY SHOULD YOU ATTEND

This webinar will 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.

AREAS COVERED

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

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

WHO WILL BENEFIT

Quality Assurance/Quality Control Directors, Managers, and Specialists 

Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists 

Engineering/Development Directors, Managers, and Specialists

SPEAKER

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.

For more details click on this link :

http://bit.ly/2D3WdKg    ;

Email: support@trainingdoyens.com

Toll Free:+1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

Comment Wall

Comment

RSVP for Proper Execution of Annual Product Reviews to add comments!

Join Online Safety Community

Attending (1)

Take our poll!

Take our poll!

Latest Activity

Mark Nilson posted events
5 hours ago
Training Doyens posted an event
Thumbnail

Time and Task Management Effectiveness: Working Smarter Every Day at 26468 E Walker Dr, Aurora, Colorado 80016

September 20, 2018 from 1pm to 2:30pm
OVERVIEWTake control of your time...and get control of your entire work day!The speed of everything has changed. Are your time management skills up to the challenge?Do you put off more today than you can ever accomplish tomorrow...exhaust yourself by 4:00 p.m. with only a fraction of your work done...see…See More
7 hours ago
Profile IconBlake Mecham, Nicole Anderson, Tse Kam Hung Danny and 1 more joined Online Safety Community
yesterday
Adam Fleaming posted a blog post

Solid Evidence That Attending Medical Devices Training Is Good for Your Career Development

Training is the foundation to producing products and services that meet regulatory and quality expectations and industrywide acceptance. This is generally true for all products and services, but in particular, for medical devices. Why? Medical devices are not in the same league as any other ordinary product that can be handled by anyone in any manner.Training is the only means by which medical device companies that manufacture medical devices and the staff that handle these products on a daily…See More
yesterday

Forum

5 TECHNOLOGY-BASED LONE WORKER SAFETY SOLUTIONS

ABOUT 75% OF EMPLOYEES IN NORTH AMERICA ARE MOBILE WORKERS. ADVANCES IN COMMUNICATIONS TECHNOLOGY MEANS THESE WORKERS CAN WORK ANYWHERE AT ANY TIME. THESE NEW TECHNOLOGIES ALSO MEAN THESE MOBILE…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 31.

Road Safety Solutions 14 Replies

The Road Safety Signs ,Barriers,Humps,Hazard Markers and Visual Warnings are some of the important marks to be observed. Signs such as "keep left",stop, "give way" should not be casually treated.…Continue

Tags: safety, gear, wear, Equipment, &

Started by Enna Henry. Last reply by Jen McDade May 31.

Remote Monitoring

Get "Safe Assets and Sound Productivity" Through Remote Monitoring.Visit:…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 23.

Python Condition Objects Tutorial in 2018 1 Reply

If you have knowledge of other programming languages, then you would know the importance of conditional statements. Conditional statements are required for taking decisions. Whenever we operate the…Continue

Tags: course, certification, training, languages, programming

Started by Elena Lauren. Last reply by Jim Chesters May 15.

Power BI Visualization Types

Visualizations in Power BI displays the visual insights from a data. In power bi service a visual can be pinned from reports to create dashboards. Visuals are used in reports.List of visualizations…Continue

Tags: COURSE, TRAINING, BI, POWER

Started by Azharuddin May 15.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service