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2019 Annual Product Quality Reviews Training Program

Annual Product Quality Reviews Preparation & Reports - FDA, EU, Canada, Japan, China, WHO, and PIC/S Regulatory Requirements

Annual 4-Part Instructor-Led Interactive Live Training Program
Instructor: Jerry Lanese Ph.D. Biography>>>

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Product Reviews are often requested by regulatory investigators. Annual Product Reviews have been a requirement of the US GMPs for pharmaceutical products since 1978. Since the turn of the century the EU and Canada have included a requirement for Annual Product Quality Reviews in their regulations or guidances covering drug products. Inadequate Annual Product Reviews has been the subject of US FDA 483 observations and Warning Letters. The concept of ongoing product, process and system reviews is a vital part of the philosophy of continuous improvement found in the Pharmaceutical Quality System outlined in ICH Q10 and the FDA Guidance to the Industry: “Quality Systems Approach to Pharmaceutical GMP Regulations”. Metrics that relate to the Product Review will be part of the FDA Quality Metrics Program and increase the importance of the Product Review. Product Reviews are a vital component of an effective Quality System and will increase in importance in the coming years.

In this comprehensive live training program, we will discuss the most recent regulatory requirements for, content and preparation of the Annual Product Quality Review (or Product Quality Reviews) required by the FDA and all GMPS throughout the world including EU, Canada, WHO, PIC/S, Japan and China as well as the impact of regulatory guidance, industry practice and other required reports on the Product Quality Review. The new focus on management involvement in the Product Review process, driven by the FDA Quality Metrics program will also be discussed.

This live training program is intended to:
• Educate and train personnel on Product Quality Reviews and activities related to the reviews.
• Update personnel who are actively involved with the preparation of a Product Review and activities supporting the preparation and follow-up of the Product Review.
• Support the regulatory requirement or continuing training of personnel in the pharmaceutical industry

This intensive four-part live training program will consist of 4 live training sessions of 2 hours each. Each session will include an additional 30-minute Q&A period following the presentation. It will include over 10 hours of live presentation and live Q&A delivered once a month over the course of 4 months. This method of delivery proves effective in providing trainees with ample time to take in, process, and put to use the information learned, and then to return to the next session with any questions, as opposed to condensing the intensive training program in to a short seminar saturating the audience by an early overload of information. The design and preparation of this advanced live training program’s content is a result of years of proven industry experience and knowledge, ensuring trainees are provided with the most up to date and real-world information on Annual Product Quality Reviews. This 4-part live training program is instructed by Jerry Lanese Ph.D. who has more than thirty years of experience in the pharmaceutical industry.

4-Part Live Training Program Breakdown:

Session 1: The Requirements
• Introduction
• Regulatory requirements around the world for the Product Quality Review
• Terminology for our discussion
• Overview of requirements for a Product Quality Review throughout the world

Session 2: The Evolution
• The evolution of drug products
• The evolution of the pharmaceutical industry
• The evolution of requirements for the Product Review
• The impact of the Quality System concept

Session 3: The Content
• The Content of the Product Quality Report
• The Product Review Process

Section 4: The Expanding Role, Responsibilities and Integration
• The Product Quality Review as it relates to:
. continued process verification
. quality metrics
• Responsibilities for the preparation of the Product Quality Review in the Virtual organization
• Integration with other reporting activities
. Management Review
. Annual Report

Session 1: The Requirements

Live, Interactive Training Webinar

Date: Wednesday March 20, 2019
Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Jerry Lanese Ph.D.


The requirement for an annual review of “the quality standards of each drug product to determine need for changes in product specifications or manufacturing or control procedures” first appeared in the US GMPS in 1978. Since the turn of the century, the requirement for a Product Quality Review has been a part of other regulations throughout the world. In this session, we will review the regulatory requirement found in regional GMPs throughout the world including:

. US GMPS; 21CFR211.180
. EU GMPs, Chapter 1, Pharmaceutical Quality System
. Canadian GMPs, Good Manufacturing Practices Guidelines GUI-001
. WHO; Good Manufacturing Practices for Pharmaceutical Products
. PIC/S Guide to Good Manufacturing Practices for Medicinal Products, Part I and Part II
. Japan: GMP Guideline for Drug Products
. China Food and Drug Administration; Good Manufacturing Practice for Drugs

With this background the discussion will move to an overview of the global requirements for a Product Quality Review.
The session will end with questions and answers.

Webinar outline and time breakdown:

Date: Wednesday March 20, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Live presentation of material
11:30 AM Break
11:40 AM Live presentation of material
12:30 PM Live Questions & Discussion


Session 2: The Evolution

Live, Interactive Training Webinar

Date: Wednesday April 17, 2019
Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Jerry Lanese Ph.D.


There have been many changes in the pharmaceutical industry since the release of 21CFR211, the Drug GMPs, in 1978. We now have sophisticated parenteral, biological and combination products and new processing techniques. The industry now includes many virtual organizations. There are products, businesses and processes not imagined in 1978. Through this time, the FDA and other organizations have issued guidance documents such as ICH Q10, the Pharmaceutical Quality System and Process Validation. The impact of these will be discussed.
The session will end with questions and answers.

Webinar outline and time breakdown:

Date: Wednesday April 17, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Live presentation of material
11:30 AM Break
11:40 AM Live presentation of material
12:30 PM Live Questions & Discussion


Section 3 – The Content

Live, Interactive Training Webinar

Date: Wednesday May 15, 2019
Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Jerry Lanese Ph.D.


This session will revolve around and in-depth discussion of what should be included in the Product Quality Review. It will be based on the overview of global requirements developed in Session 1 and develop a detailed list of information, analysis and recommendations that should be included in the Product Quality Review. The various targets for the Product Quality Review – Quality, Production and Management - will be considered throughout the discussion. The participant will be able to develop a check list of items that should be included in his/her product review.

The session will conclude with a discussion of the process for the preparation and the need for clear procedures that define responsibilities and timelines. The challenges of preparing the Product Quality Review in a virtual organization will be discussed.
The session will end with questions and answers.

Webinar outline and time breakdown:

Date: Wednesday May 15, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Live presentation of material
11:30 AM Break
11:40 AM Live presentation of material
12:30 PM Live Questions & Discussion

Session 4 – The Expanding Roles and Integration

Live, Interactive Training Webinar

Date: Wednesday June 19, 2019
Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Jerry Lanese Ph.D.


As the industry has evolved, reports, other than the Product Quality Review and the Annual Report, such as Quality Metrics, continued process verification and the Management Review, have been required or proposed in regulations and guidances. The impact of, and relation of these to the Product Quality Review and possible synergies in the responsibilities for and preparation of the various reports will be discussed. The impact of the virtual organization will be a continuing consideration.
This session will conclude with a review of all of the material presented in the four sessions and a final question and answer covering all of the material.

Webinar outline and time breakdown:

Date: Wednesday June 19, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Live presentation of material
11:30 AM Break
11:40 AM Live presentation of material
12:30 PM Live Questions & Discussion

Handouts will include:
• Lecture notes
• A copy of the regulations discussed
• A master table of the regulatory requirements for a Product Quality Review

Click Here to Register for this Live Training Program >>>


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Instructor: 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>>>

 

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

Clients: