“Deconstructing Warning Letters” - Using Warning Letters to Illustrate the FDA and Health Canada CFRs

Live, Interactive Training Webinar

Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>

Schedule & Deliver this Live Training Webinar Privately to Your Group

Warning Letters are continuing to occur at a frequency that mirrors previous years. However, one of the major differences is that many of them are now originating in India, the second largest supplier of Active Pharmaceutical Ingredients (API) and finished drug products. The FDA, having recognized this, has now increased their staff to three offices and nineteen investigators within the country.

As a result of this enhanced presence, more Warning Letters are arising from this country and provide excellent examples of issues that everyone should heed. The Observations provide room for reflection upon not just these Observations, but also the CFRs that form their basics. Many of the Observations suggest that the Investigators are merely retrieving "low hanging fruit" and must ask the question of what will the Investigator find with the really difficult areas to include analytical chemical method validations, equipment qualifications, cleaning validations, bacterial endotoxin testing, etc.

The objective of this live and interactive webinar is to explore the various CFRs and observe how these various regulatory requirements lead to Observations and determine what the Observations mean, how the regulators interpret the requirements and how they are reflected within the final document that the Client receives. This live webinar is a MUST for anyone in your organization that is required to reply to or review regulatory Observations.

Learning Benefits:
-Explore the most common Observations that the Agency has issued
-Understand the requirements and actions that an Organization must take based on these common Observations
-Review the issues that occur when an Organization does not fully understand the Observations
-Review Case Studies of specific Warning Letters
-How to share Warning Letters that are immediately relevant and actionable
-Review the “deconstruction” of a Warning Letter
-Review current FDA inspectional emphases in Warning Letters
- How to use Warning Letters to anticipate inspectional priorities

Webinar outline and time breakdown:

Time*
12:45 PM Log In Period
01:00 PM Introduction
01:10 PM Definitions,
Understanding the Warning Letter process – from Inspection to Enforcement Exploration of Regulatory Requirements,
Peruse the Derivation of the Regulatory Requirements,
How to analyze a Warning Letter – Code phrases, prioritization points and more
How to analyze a Warning Letter – Code phrases, prioritization points and more
How to read “between the lines” of a Warning Letter,
Identification of the routine sampling requirements,
02:00 PM Break
02:10 PM How to share Warning Letters that are immediately relevant and actionable,
Review current FDA inspectional emphases in Warning Letters,
How to use Warning Letters to anticipate inspectional priorities
Review of current Warning Letters
03:00 PM 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 certificate of participation for attendee training records

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

  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Regulatory Affairs Professionals
  • Validation
  • Incoming Materials and Receiving

Schedule & Deliver this Live Training Webinar Privately to Your Group

Barry.jpg

Instructor: Barry A. Friedman Ph.D.

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>

 

 

 

System Requirements:

All Pharma Webinars live training programs audio and visual are delivered via Cisco WebEx with basic system requirements of a computer with internet access and a telephone to access the audio portion of the presentations. You can choose to access the audio through your computer.

Live Training Benefits:

• Pharma Webinars training webinars and programs are presented exclusively as live events only.

• Designed and delivered based on e-learning best practices, Pharma Webinars' live training webinars and programs are as effective as in person training.

• Live training webinars and multi-part training programs are strictly educational based, and do not promote or endorse any products or services whatsoever.

• An interactive live Q&A and discussion period is included in each live training presentation. Questions can also be submitted to the speaker via email both prior to and following the live training webinar as a means of improving participant experience, and ensuring successful topic comprehension.

• Live presentations ensure that all live training webinars and programs are engaging and informative, allowing trainees to exchange ideas through audio conferencing and live chat during each presentation in real time. Each live training session includes a dedicated live Q&A period allowing trainees to interact directly with the instructor, with quick feedback providing them with concrete understanding of the answers and the training subject itself.

• Each Pharma Webinars live training webinar and program content is updated on regular basis to provide the latest regulatory, operational and technological trends in the international pharmaceutical arena. As regulatory expectations, guidance, or industry trends change, so does our training in order to reflect those changes as soon as the changes are released.

• Pharma Webinars' instructors are the most recognized subject matter experts in the industry who are selected based on very strict qualification criteria. They are coached on the latest e-learning speaking methods in order to make each presentation engaging, memorable and very effective.

• Each registered attendee receives an exact copy of the presentation slides and other course handouts significantly reducing the learning curve as trainees can refer back to this material in the future.

• All trainees receive a Certificate of Attendance for each live training webinar and program they attend to be kept for training records.


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