Compliance in the Laboratory – FDA, ICH and USP Requirements & Guidances for Laboratory Controls & Areas of Focus During Regulatory Inspections

Live, Interactive Training Webinar

Available Live On-Demand
Instructor: Jerry Lanese Ph.D. Biography>>>

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The Quality Control Laboratory has become a focal point for regulatory inspections and a significant source of regulatory observations. In order to operate in a compliant manner and avoid regulatory observations, the laboratory must diligently address compliance and proactively implement improvements in laboratory operations that reflect the changes in regulatory expectations consistent with a Quality System approach and contemporary guidance.

In order to operate in a compliant state, the laboratory must go beyond the words in Subpart I, Laboratory Controls, and other applicable paragraphs of the GMPS, it must implement systems that meet the intent of recent guidances and offer a contemporary interpretation of the intent of the GMPs.

In this live training webinar we will discuss Laboratory Controls with a contemporary interpretation derived from guidance found in the FDA System Based inspection guidance, ICH Q10, The Pharmaceutical Quality System, ICH Q8, Product Development, ICH Q9, Quality Risk Management, the FDA guidance on Process Validation, the FDA guidance on Quality Metrics, the FDA guidance on Data Integrity, and many other guidance documents and contemporary quality philosophy.

Learning Benefits
-The Latest requirements for Laboratory Controls found in the GMPS.
-The impact of recent FDA, international and USP guidance on the interpretation of Laboratory Controls.
-What the FDA is looking for based on the Quality System concepts.
-Use of System Based Inspectional Guidances as a source for internal audits.
-Areas of FDA focus during an inspection.
-Things to look for in the internal audit of the Quality Control Laboratory.

Webinar outline and time breakdown:

09:15 AM Log In Period
09:30 AM Introduction
09:40 AM The foundation of FDA expectations for the laboratory – the GMPs,
The ICH trio, Q10, Q8, and Q9 and their impact on Laboratory Controls,
The Laboratory Control System within a System Based Inspection,
10:30 AM Break
10:40 AM The FDA hot buttons found in observations,
Internal audit to maintain compliance,
Process validation – applied to Test Method Validation,
Impact of new guidance – Quality Metrics and Data Integrity,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A copy of the FDA Stimulus Article on Test Method Validation
  • A copy of the FDA Quality Metrics Guidance
  • A copy of the FDA Data Integrity Guidance
  • A certificate of training for attendee training records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Senior management
  • Quality management
  • Quality Assurance managers and auditors
  • Quality Control personnel at all levels
  • Analytical Development personnel

Schedule & Deliver this Live Training Webinar Privately to Your Group

Instructor: John G. (Jerry) Lanese Ph.D.

John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan. Since leaving graduate school, Dr. Lanese has had post doctoral research appointments, taught at the college level, filled several Quality Unit positions in the pharmaceutical industry and for the past 15 years he has been an independent consultant, with a focus on the FDA regulated industries. As part of his consulting practice Jerry lectures throughout the world on a variety of topics related to Quality Systems. He was named the Best Seminar Presenter of the year 2001 by the Institute of Validation Technology. In 2005, his article “Training and the Laboratories” was selected as best article of year by the Journal of GXP Compliance. Recently, in 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry… Full Bio>>>


Course Number: 277

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland