Effective Laboratory Controls – How To Prepare for a System-Based FDA Audit | November 2, 2018, 2 PM EDT | Lanese
August 21st, 2018 // 8:56 pm @ jmpickett
This popular Webinar on drug laboratory controls focuses on all of the systems that are in a laboratory that will be audited by an FDA inspector in a typical systems-based inspection. After this 90 minute Webinar, you will fully understand how to prepare your laboratory for FDA.
Why should you attend?
We notice that many QA and QC personnel in the pharmaceutical industry are not aware of FDA moving to a systems-based inspection model. They are also not aware of the types of 483 observations that many FDA auditors make today. One of the key areas of any FDA audit is the lab. So, it is vital for all lab personnel to know the systems-based techniques of FDA. You also must know the systems FDA is going to examine, and how your lab can get ready for the FDA auditor.
Since 2001, FDA has been using its systems-based audit techniques for all audits of drug and biological plants.
This Webinar will focus on lab responsibilities and will deal with:
- What makes up the Laboratory Control System
- The responsibilities of the QC Laboratory
- Responsibilities of the QC unit
- 2010-12 FDA 483 citations that have come from deficiencies in the Quality Control Laboratory. You also will learn the cause and how to avoid it.
- The impact of the systems concept on the organization
Areas Covered in the Webinar
- What is a Systems Based Inspection.
- Why FDA moved to Systems Based Inspections.
- What is different from the old inspectional techniques.
- What is the Laboratory Control System.
- Has the new technique changes the findings?
- What are the responsibilities of the various units in the organization, specifically the QC lab
- What are the specific things the FDA will look at in its lab audit?
- Future trends – What other changes might be coming in FDA lab audits in the future?
Who Should Attend
This webinar will help the personnel in the quality control laboratory understand their role in the new FDA focus on systems. It will also help quality control personnel understand their role in all aspects of the Systems Based Inspections. The following employees will want to attend:
- Personnel who have responsibilities in laboratory operations, including Directors, managers and line personnel.
- QA directors, managers and those involved with Change Control, deviation investigations and Training.
- Personnel in analytical development developing new methods.
- Validation specialists.
- Personnel involved with the testing of all dosage forms.
With your order, we would like to offer you these six items at no added cost:
- Powerpoint slides to share
- Downloadable recording
- Article – 21 CFR Part 11 Enforcement – Where Is FDA Headed? By John Avellanet, Cerulean Associates
- Article – 10 Ways to Control Compliance Costs – By John  Avellanet, Cerulean Associates
- Guide – An Executive Guide to Quality by Design – By John Avellanet, Cerulean Associates
- Newsletter – FDA Digest – By Expertbriefings.com. Latest FDA regulatory news, and recent 483 and warning letter analysis – 12 issues only $399.00
About the Speaker
Dr. John G. (Jerry) Lanese, PH.D. is the President of The Lanese Group, Inc, an independent consulting service provider that specializes in Quality Systems and Laboratory Controls. Jerry has taught at the college level and worked in various Quality Control and Quality Assurance roles in small and large pharmaceutical firms. For the last 15 years he has consulted in a wide range of projects from consent decree remedial actions with large pharmaceutical firms to systems development for a small device component manufacturer. He has lectured throughout the world to clients and for major seminar providers. He was voted the best presenter of the year in 2001 by the Institute of Validation Technology. In 2008 he received the Kenneth Chapman Industry Recognition Award.
