Webinar Includes : All the training handouts , certificate ,Q/A and 240 mins Live Webinar
Join us for a webinar on September 10 for a discussion of the webinar
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.
Who should attend
The following individuals or disciplines will benefit from attending this Webinar within the Pharmaceutical Manufacturing Industry.
- Quality Assurance personnel
- Quality Control personnel
- Manufacturing
Webinar Takeaway
Session 1: Review of FDA Observations
Learning Benefits:
- Support paper of observations from 2017 – 2019
- Procedures
- Investigations
- Testing
- Overview of this series
Session 2: Technical Writing for the Pharmaceutical Industry
Learning Benefits
Clear
Easy to understand
Make sure others read the document
Concise
Technically accurate
Equipment names
Pictures
Diagrams
Compliant
QA sign off
QA input
Structure of document meets requirements
Case Studies
Case Study 1
Case Study 2
Case Study 3
Session 3: Understanding Quality Control Testing
Learning Benefits
- Why do we test prior to release?
- Why do we test materials coming in?
- Safety, Quality, Identity, Potency, Strength
- USP/EP
- 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
Learning Benefits
- 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 1
Case Study 2
Case Study 3
Can't Make this LIVE Webinar?
Simply select the Recorded option when registering and we will send you the link to view the recorded version.
Who Will Benefit
- Manufacturing Personnel (Associates and Supervisors) and Managers.
- Quality Control Personnel (Associates and Supervisors)
- Quality Assurance Personnel (Associates and Supervisors)
Industries who can attend
This 240 -minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.
Faculty Carl Patterson
Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance Professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However, his avid interest in all things biology, microbiology, and biochemistry officially began when he served in the U.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse. Furthermore, Carl holds various degrees and certifications, including an M.S. in Biomedical Quality Systems from San Diego State University, a B.S. in Microbiology from the University of Texas, and Specialized Certificates in QA/QC & Biotechnology from UCSD.