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Process Validation & Defining What Is Critical

Bikash Chatterjee discusses the importance of linking process design to product performance, and defining critical process parameters.
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Design Space Development — How (And When) To Get Started

Design Space Development — How (And When) To Get Started | Pharmatech Associates articles | Scoop.it

Design space is a scientific concept used in the pharmaceutical/biopharmaceutical industry to support and assure product quality.

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In early-stage product development, the challenge of finding the optimal design space is determining what is important to achieve consistent product quality. A stepwise approach should be taken in the formulation and development process to capture characteristics or attributes that could impact product quality.
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Controlled Environments - September/October 2016 - 16

Controlled Environments - September/October 2016 - 16 | Pharmatech Associates articles | Scoop.it
Controlled Environments is a leading source of information on contamination prevention, detection, and control for cleanrooms and critical environments. Controlled Environments provides relevant and timely content on trends, technology, and applications for controlled environments professionals. Controlled Environments covers everything from pure, materials to protective packaging, from state-of-the-art facility construction through day-to-day cleaning and control challenges that affect quality and yield. The print and online Buyer's Guide provides a single-source listing of vendors, products, equipment, services, and supplies for microelectronics, pharmaceutical, and life science industries. Free subscriptions to our comprehensive daily e-newsletter and monthly magazine available at www.cemag.us.
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An article in Controlled Environments magazine by Richard Aleman of Pharmatech Associates relates how to avoid an FDA warning letter in the lab environment, where an ounce of prevention is worth a pound of cure. 
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Managing Cold Chain Distribution Across the Global Supply Chain: Trends and Regulations

Managing Cold Chain Distribution Across the Global Supply Chain: Trends and Regulations | Pharmatech Associates articles | Scoop.it

Cold chain performance is subject to the same pressures as normal supply chain process to push performance and drive down costs. Many pharma companies have turned to third party logistics (3PLs) firms that are incentivized to make the necessary investments in technology, infrastructure, and systems to drive continuous improvement and gain a competitive market edge.

-- Article by Bikash Chatterjee, featured in July/ August 2016 issue of Pharmaceutical Outsourcing.

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To be effective, cold chain strategy requires the thoughtful integration of cold chain requirements starting with product design and extending to environmental control during transit. Integrating Quality Risk Management (QRM) principles at strategic points within product development is the best way to anticipate downstream cold chain challenges.
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Effective Risk Management: A Catalyst For Quality Performance

Effective Risk Management: A Catalyst For Quality Performance | Pharmatech Associates articles | Scoop.it

When we think of risk in the context of drug development and manufacturing, it is human nature to associate any risk-based approach with adding risk...instead of managing it.

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Article by Bikash Chatterjee in Pharmaceutical Online - June 2016

Today’s model for drug development and commercial manufacturing leverages external expertise, capabilities, and geography. Integrating strategies for each of these elements can significantly impact an organization’s quality management system (QMS) effectiveness. Structuring a quality risk management (QRM) framework as part of the core systems (deviation management, change control, and audits/supplier management) brings a consistent methodology that guides quality decision-making and a sound means for evaluating technical and financial risks during drug development. 

World-class organizations already know that QRM can be the catalyst for organizational performance across the product development lifecycle because it eases development collaboration between technical and quality functions all the way up through commercial execution.
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Professional Profile: Richard Aleman

Professional Profile: Richard Aleman | Pharmatech Associates articles | Scoop.it
Richard Aleman of Pharmatech Associates, profiled in Controlled Environments magazine - June 2016
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Richard Aleman of Pharmatech Associates shares some career advice in a profile published in Controlled Environments magazine. Aleman is VP of Regulatory Compliance for the Bay Area life sciences consultancy. He has 28 years of FDA experience in both the field and headquarters organizations, specializing in biopharmaceuticals, drugs and medical devices, including serving as the Biologics Specialist at the FDA’s Miami Resident Post.
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The Promise and Challenge of Next Generation Gene Sequencing

The Promise and Challenge of Next Generation Gene Sequencing | Pharmatech Associates articles | Scoop.it
Since the first complete human genome sequence was mapped in 2003, pharma and biotech  investigators have been looking for new and innovative ways to gain insight into the genetic drivers of the
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Industry titans Biocon, PBOA, Biotec Services and Pharmatech Associates join CPhI annual report for 2015 - News Press Release | PharmiWeb.com

Industry titans Biocon, PBOA, Biotec Services and Pharmatech Associates join CPhI annual report for 2015

Joining the CPhl Expert Panel for 2015 is Bikash Chatterjee, President and CSO at Pharmatech Associates, who will discuss the impact of Process Validation Harmonization on Drug Development and QbD in the 2015 annual report.

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The new members increase the panel’s expertise across industry critical issues in biologics, clinical trials, outsourcing and pharmaceutical process validation.

 

Pharmatech Associates' Bikash Chatterjee is a renowned advisor of global pharma and biotech companies

More: http://www.pharmiweb.com/PressReleases/pressrel.asp?ROW_ID=121657#.Vakb6SpVhBc#ixzz3gA7mFSMc

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Predicting Meaningful Process Performance

Predicting Meaningful Process Performance | Pharmatech Associates articles | Scoop.it
Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria.
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A new article in the April 2015 issue of Pharmaceutical Technology magazine by Mark Mitchell, Pharmatech Associates, describes how to use process validation design data to establish process performance qualification acceptance criteria, in drug manufacturing. Mitchell clarifies what seem to be difficult and abstract concepts, using practical examples.

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Serialization and the Drug Quality & Security Act

Serialization and the Drug Quality & Security Act | Pharmatech Associates articles | Scoop.it
The supply chain for genuine pharmaceuticals has grown longer, and every step in the chain offers an opportunity for counterfeiters
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January 2015 article in Pharmaceutical Manufacturing magazine, by Bikash Chatterjee, Pharmatech Associates.

 

In this era of globalization, the supply chain for genuine pharmaceuticals has grown longer, and every step in the chain offers another opportunity for counterfeiters. Pharmaceutical companies and governments worldwide believe that counterfeiting can be reduced significantly by implementing product serialization. Serialization requires a comprehensive system to track and trace the passage of prescription drugs through the entire supply chain, from production to distribution.

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Implementing Risk-Based Validation Team-by-Team, by Moria Feighery-Ross

Implementing Risk-Based Validation Team-by-Team, by Moria Feighery-Ross | Pharmatech Associates articles | Scoop.it

Article by Moria Feighery-Ross of Pharmatech Associates, in Pharmaceutical Manufacturing Magazine.

Solid, defensible execution of Risk-Based Validation requires strong collaboration between QA, PE and maintenance.

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Risk-based validation is a validation philosophy in which the qualification and validation processes are streamlined through an objective assessment of the risks to product quality posed by equipment functionality, process steps, or process capability. Quality is defined in terms of identity, purity, potency and safety. Performing validation using a risk-based philosophy allows us to focus our energies in time and testing on the areas where we most strongly need to be assured of quality performance.

Pharmatech Associates' approach to risk-based validation can benefit all phases of a company’s lifecycle,

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Lean Six Sigma From An Outsourcing Industry Raconteur

Lean Six Sigma From An Outsourcing Industry Raconteur | Pharmatech Associates articles | Scoop.it

Bikash Chatterjee knows all about Lean Six Sigma. He’ll share that wisdom with us at Outsourced Pharma West in San Francisco, November 11-12, 2014.

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Louis Garguilo, Executive Editor of Outsourced Pharma interviews Bikash Chatterjee of Pharmatech Associates, author of the new book "Applying Lean Six Sigma in the Pharmaceutical Industry."

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Newsmakers: Lean Six Sigma and Seeing the Forest Behind the Trees

Newsmakers: Lean Six Sigma and Seeing the Forest Behind the Trees | Pharmatech Associates articles | Scoop.it
A new book on Lean Six Sigma aims to go beyond the tools, to uncover deeper potential within organizations
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Last month, Gower Publishing released the book “Applying Lean Six Sigma in the Pharmaceutical Industry,” by Bikash Chatterjee, President and CTO of Bay-area based Pharmatech Associates. Chatterjee has worked in pharma applying the principles involved for more than two decades in over 30 countries.  He shared some of his thoughts on the place of Lean in pharma and biopharma.


Full article at: http://www.contractpharma.com/issues/2014-09-01/view_features/newsmakers-lean-six-sigma-and-seeing-the-forest-behind-the-trees/#sthash.qX4da4el.dpuf

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Controlled Environments - November/December 2016 - 18

Controlled Environments - November/December 2016 - 18 | Pharmatech Associates articles | Scoop.it
Controlled Environments is a leading source of information on contamination prevention, detection, and control for cleanrooms and critical environments. Controlled Environments provides relevant and timely content on trends, technology, and applications for controlled environments professionals. Controlled Environments covers everything from pure, materials to protective packaging, from state-of-the-art facility construction through day-to-day cleaning and control challenges that affect quality and yield. The print and online Buyer's Guide provides a single-source listing of vendors, products, equipment, services, and supplies for microelectronics, pharmaceutical, and life science industries. Free subscriptions to our comprehensive daily e-newsletter and monthly magazine available at www.cemag.us.
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In the therapeutic drug landscape, combination products are one of the bright spots, with new and innovative drugs and effective delivery systems joining to bring improved medicines to a wide public. “Combo products” are composed of any blend of a drug and device. Bikash Chatterjee of Pharmatech Associates describes several areas that commonly impact combination product development and represent regulatory risk.Share your insight
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Best Practices For Measuring System Quality For Drug-Device Combination Products

Best Practices For Measuring System Quality For Drug-Device Combination Products | Pharmatech Associates articles | Scoop.it

Combination product development is a complex matter governed by different areas of regulatory oversight. Part 2 of Bikash Chatterjee's article discussing QMS in combination products, the challenges and their resolution.

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When it comes to combo devices, the problems of integrating device and drug quality management systems (QMS) and development requirements are of a practical nature. The regulatory pathway is clearer, thanks to 21 CFR 4, but combo products require careful preparation. Many companies find themselves scrambling for the necessary documentation to support a combination drug filing, only to realize that cost and time required are high. This article lays out the common pitfalls and the primary technical and program questions to lower your program risk on the road to a successful regulatory and commercial outcome.
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Managing QMS Disparities Between Drugs And Devices For Combination Products

Managing QMS Disparities Between Drugs And Devices For Combination Products | Pharmatech Associates articles | Scoop.it

Combination products represent a remarkable opportunity to extend the potential patient population for biologics and improve the delivery of drug therapies. This is one of the most dynamic segments in the life sciences, projected to grow to $115 billion by 2019. Article by Bikash Chatterjee, Pharmatech Associates - Part 1.

judycurtis's insight:
A combination product is defined as a product composed of any combination of a drug and a device. This could be a biological product and a device; a drug and a biological product; a drug and a device; or a drug, device, and biological product. Each component of a combination product is regulated by different chapters of the Code of Federal Regulations (CFR), which adds a layer of complexity for many organizations developing them. 

 Here is the regulatory dilemma: Drugs are regulated by 21 CFR 210/211, medical devices by 21 CFR 820, HCT/Ps (human cells, tissues, or cellular or tissue-based products) by 21 CFR 1271, etc. An organization’s ability to harmonize its product development and quality management systems (QMS) to accommodate these differences is central to the successful commercialization of a combination product. 
 
In the first of this two-part series, Bikash Chatterjee of Pharmatch Associates examines some of the common pitfalls drug companies face when they pursue the development of a combination product.
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Professional Profile: Bikash Chatterjee

Professional Profile: Bikash Chatterjee | Pharmatech Associates articles | Scoop.it
Controlled Environments spoke with Bikash Chatterjee, the author of the CE column “Regulatory Forum.” Bikash is President and Chief Science Officer of Pharmatech Associates, a Hayward, Calif.-based company that provides consulting and services to the regulated life science industry.
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In an interview in Controlled Environments magazine, Bikash Chatterjee of Pharmatech Associates shares his enthusiasm for the life-long learning opportunity offered by a career serving the regulated life sciences industries.
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DSCSA Support: The Benefits of Leveraging EPCIS

DSCSA Support: The Benefits  of Leveraging EPCIS | Pharmatech Associates articles | Scoop.it
The pharma industry is exploring the use of the Electronic Product Code Information Service to help meet the immediate and long-term requirements of the Drug Supply Chain Security Act
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In Pharmaceutical Manufacturing magazine, Bikash Chatterjee of Pharmatech Associates contributed information on the three-phased Drug Quality and Security Act (DQSA), underway until 2019. DQSA creates a single unified federal framework to address supply chain integrity: The Drug Supply Chain Security Act (DSCSA) outlines the steps to build an electronic interoperable system to track and trace prescription drug distribution. 
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Held Hostage!

Held Hostage! | Pharmatech Associates articles | Scoop.it

"Ransomware’s threat to healthcare," by Bikash Chatterjee, Pharmatech Associates. From laptops to smartphones to intelligent car consoles, securing proprietary or sensitive data has never been more difficult. With systems designed to promote connectivity, the threat profile today is changing as fast as the sophistication of our electronic devices. The rising tide of ransomware attacks targeting hospitals reveals a threat that goes beyond protecting data from theft, as crypto-extortion can affect data in place. Hackers already exploit inherent vulnerabilities in health IT systems and medical devices, many of which run outdated and vulnerable software.

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The threat to intelligent medical devices is compounded by the now-frequent ransomware attacks on healthcare and research organization networks. Bikash Chatterjee's article in Controlled Environments magazine details the problem and remedies suggested by recent FDA guidance.
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Personalized Medicine, Companion Diagnostics, and NGS Diagnostic Tests

Personalized Medicine, Companion Diagnostics, and NGS Diagnostic Tests | Pharmatech Associates articles | Scoop.it
Personalized medicine has the potential to be the biggest advance in health in many decades.
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Bikash Chatterjee writes, in the latest Regulatory Forum column in Controlled Environments magazine, that realizing the promise of personalized medicine requires a shift in the way the pharma/biotech industries define quality, efficacy, and safety in personalized drug therapies as well as their companion diagnostics. 


The FDA continues to refine its position on Companion Diagnostics and is working on more detailed guidance. Chatterjee warns that the agency will also have to consider the broader implications of Laboratory Derived Tests (LDTs).

 

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A Framework for Managing Supply Chain Integrity and Supplier Quality | Pharmaceutical Outsourcing - The Journal of Pharmaceutical & Biopharmaceutical Contract Services

A Framework for Managing Supply Chain Integrity and Supplier Quality | Pharmaceutical Outsourcing - The Journal of Pharmaceutical & Biopharmaceutical Contract Services | Pharmatech Associates articles | Scoop.it
A Framework for Managing Supply Chain Integrity and Supplier Quality
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Bikash Chatterjee and Jorge Basso of Pharmatech Associates 

advocate taking a product lifecycle approach to supplier quality in an article in Pharmaceutical Outsourcing.

Ensuring quality and integrity in the global supply chain is complex and involves working with evolving, disparate requirements. A framework to manage integrity and quality helps understand and control current systems and meet the supply chain integrity requirements for the U.S. and most major global markets. 
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Implications of the FDA’s Program Alignment Plan

Implications of the FDA’s Program Alignment Plan | Pharmatech Associates articles | Scoop.it
In late 2013, the FDA announced it was embarking upon a program to realign its structure and programs to keep up with the challenges posed by advances in science, globalization, and product complexity.  By February 2014, FDA Commissioner Margaret Hamburg, M.D., had unveiled the sweeping changes to the agency that will see its many divisions reorganize to become more specialized.
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Regulatory Column by Bikash Chatterjee, Pharmatech Associates, outlining FDA's new emphasis on regulatory and compliance and emergence of the Office of Regulatory Affairs (ORA). March 2015. 

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Preparing for the Drug Quality Security Act

Preparing for the Drug Quality Security Act | Pharmatech Associates articles | Scoop.it

Regulatory Forum article, in Controlled Environments magazine, by Bikash Chatterjee, Pharmatech Associates.

 

The advent of the Drug Quality Security Act (DQSA) will bring escalation in IT infrastructure and data integration over the next five to seven years. Compliance will require a focused effort and significant investment in identifying the data generation, capture, transmission, and reporting elements across all marketplaces. It is not a side project.

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This guidance represents a major step forward for the U.S. drug industry to thwart counterfeiting and drug diversion activity, and to promote safety in a modern way.

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Applying Lean Six Sigma in the Pharmaceutical Industry - Project Management World Journal

Applying Lean Six Sigma in the Pharmaceutical Industry  - Project Management World Journal | Pharmatech Associates articles | Scoop.it
BOOK REVIEW Book Title: Applying Lean Six Sigma in the Pharmaceutical Industry Author: Bikash Chatterjee Publisher: Gower publishing List Price:   US$95.00 Format: Hard cover; 152 pages Publication Date:   2014 ISBN: 978-0-566-09204 Reviewer:     ...

Via Steven Bonacorsi
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New review of Bikash Chatterjee's book "Applying Lean Six Sigma in the Pharmaceutical Industry" - Gower Publications. 

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Risk and Quality Management: Connecting the Dots

Risk and Quality Management: Connecting the Dots | Pharmatech Associates articles | Scoop.it
A brief review of pharma’s new thinking regarding quality and risk management, and key risk management tools
judycurtis's insight:

Excerpts from Chapter 2 (titled Trouble in Paradise and Catalyzing Change) of Bikash Chatterjee’s new book,” Applying Lean Six Sigma in the Pharmaceutical Industry,” are reproduced by permission of the author and publisher. 

 

The book is published by Gower Publishing, Ltd., ISBN 978-0-566-09204-6

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Ad: Gower's new Pharmaceutical and Healthcare Industry Catalogue

Ad: Gower's new Pharmaceutical and Healthcare Industry Catalogue | Pharmatech Associates articles | Scoop.it

Pharmaceutical and Healthcare Industry books from Gower


'To know your future you must know your past.'


quotes Gower author Bikash Chatterjee in his new book Applying Lean Six Sigma in the Pharmaceutical Industry. 'The truth is, any improvement effort must understand the factors that formed its current state if an effective improvement is to be achieved.'

  Wise words indeed!

 

There are plenty more wise words within the content of Gower's new Pharmaceutical and Healthcare Industry Catalogue. Packed with volumes from expert authors such as Ed Schoonveld, John Ansell, Lorri Zipperer and Laura Brown, it contains a wealth of insight and assistance throughout all aspects of the industry. We have also added a healthy dose of leadership, safety and risk books for good measure.

 

You can view the catalogue on our website in eithereCatalogue or standard PDF formats.

 

Each title within the catalogue is hyperlinked so you can simply click to find out more information, download a free sample chapter or order online.

 

Remember, all orders placed via our websitewww.gowerpublishing.com, receive an automatic 10% discount.

 

If you like what you read, do sign up to the Gower newsletter where you will receive information about our latest titles, exclusive rewards, promotions and access to free content.


Via Pharma Guy
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Pharmatech Associates' Chief Scientific Officer, Bikash Chatterjee, 

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Pharma Guy's curator insight, August 27, 2014 1:34 PM


There are several books in Gower's Pharmaceutical and Healthcare Industry Catalogue that you may find interesting.