Module 1: Review of FDA Observations 16th November at 1:30 PM EST to 2:30 PM EST
Module 2: Technical Writing for the Pharmaceutical Industry 17th November at 1:30 PM EST to 2:30 PM EST
Module 3: Understanding Quality Control Testing 24th November at 1:30 PM EST to 2:30 PM EST
Module 4: Detailed Investigations: How to avoid an observation 1st December at 1:30 PM EST to 2:30 PM EST
Who Will Benefit
- Manufacturing Personnel (Associates and Supervisors) and Managers.
- Quality Control Personnel (Associates and Supervisors)
- Quality Assurance Personnel (Associates and Supervisors)
Session 1: Review of FDA Observations
Live, Interactive Training Webinar Monday November 16, 2020
- Support paper of observations from 2017 – 2019
- Overview of this series
Session 2: Technical Writing for the Pharmaceutical Industry Tuesday November 17, 2020
- Easy to understand
- Make sure others read the document
- Technically accurate
- Equipment names
- QA sign off
- QA input
- Structure of document meets requirements
- Case Study 1
- Case Study 2
- Case Study 3
Session 3: Understanding Quality Control Testing
Tuesday November 24, 2020
- Why do we test prior to release?
- Why do we test materials coming in?
- Safety, Quality, Identity, Potency, Strength
- Method Validation
- Setting specifications
- Appropriate (Make sense?)
- What should have a specification?
- Based on Data
- Get input from all Departments
Session 4: Detailed Investigations: How to avoid an observation Tuesday December 1, 2020
- Who should be conducting an investigation?
- When is an investigation necessary?
- What constitutes an investigation?
- What is a root cause?
- What tools can be used to determine the root cause?
- What if a root cause could not be determined?
- Corrective Actions/Preventative Actions
- Case Studies of Investigations and Actions
Case Study 1Case Study 2Case Study 3
Review of Webinar Series
This comprehensive 4-Part live training program includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of participation for attendee training records
- Q/A Session
This webinar series will go over the most recent observations given by the FDA. The top three observations will be discussed within the series.
A comprehensive review on all the modules will be given once the final module is completed. These modules will provide insight into what the FDA is looking for during an audit and provide participants with tools and case studies for each of the topics.
Why Should You Attend
The FDA is a regulatory body that can shut down a manufacturing facility then the company loses time and money due to the closure. For this webinar series, we are providing the most common observations given by the FDA and provide ways to prevent these most common observations.