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QRM and the System Classification “Big Reshuffle”: Don’t Miss the Forest for the Trees

By Chip Bennett, November 2, 2020

Recently, under its new Insights offering, KenX published an article, The Big Reshuffle – Impact Assessments and System Criticality, discussing the implications regarding the change in approach from System Level Impact Assessment (SLIA) and Component Criticality Assessment (CCA) to System Classification (SC) and System Risk Assessment (SRA) in ISPE Baseline Guide Volume 5, Commissioning & Qualification, 2nd Edition (2019). It is, on the whole, an excellent article and well-worth the time to read. In describing the impact of the “big reshuffle”, the article addresses some common practices and paradigms that I believe merit further discussion, particularly with respect to understanding the role of System Classification and System Risk Assessment in the application of Quality Risk Management (QRM) principles to the integrated Commissioning & Qualification (C&Q) process.

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Implementing Data Infrastructure for Advanced Analytics

By Eric Collier, October 20, 2020

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Plan for the Unplanned: A Quick Guide to Troubleshooting

By Sam Willis, September 10, 2020

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Understanding Failure to Ensure Proactive Maintenance

By Robert Smith, July 30, 2020

In today’s highly competitive environment, eliminating unplanned downtime is more important than ever, especially when that downtime occurs during a batch that places the product at risk. Did you know “best-in-class” maintenance organizations spend 90% of their total maintenance time on proactive maintenance (planned, kitted and scheduled corrective, preventive, and predictive tasks) and the remaining 10% on reactive (unplanned) maintenance work? There are many activities these “best-in-class” organizations do exceptionally well to achieve this high level of proactive maintenance performance. This article will look at how a greater understanding of failure will help your organization develop the right mindset to achieve “best-in-class” proactive maintenance performance levels.

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Why Don’t OEM Recommendations Work for Maintenance?

By Nick Armstrong, July 16, 2020

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You Can't Distance From Quality

By David Shenberger, June 15, 2020

As an essential business, which must continue functioning in the current global environment, Pharmaceutical Manufacturing companies face unique challenges. Pharmaceutical Manufacturing relies on operating in a controlled state, which stems from Quality Systems in six significant areas. With the current COVID-19 outbreak, this may require adjustments to the way the plant operates typically. Decisions require a scientifically sound process.

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Is CSA Really a Game Changer for the Life Science Industry?

By Brian Stephens, June 11, 2020

Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software Guidance – Is it the solution to arduous validations that the life science industry has been waiting for from the FDA?

Least Burdensome Approach to Validation – the Food and Drug Administration (FDA) has been pushing this concept onto life science companies for the past two decades, with less-than-desired results. The FDA's upcoming CSA guidance promises to be a useful tool to help the industry finally achieve this elusive goal.

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Best Practices in Technology Transfer

By Charlie Maher, May 28, 2020


Technology Transfer and the Product Lifecycle

Technology transfer is integral to the lifecycle of virtually every pharmaceutical product. Tech transfer enables a product to advance from the development lab into clinical manufacturing and then scale-up to commercial production. As demand grows, tech transfer is instrumental in adding additional manufacturing capacity at locations across the globe. Tech transfer may involve site-to-site transfers internal to a sponsor company, transfers between a sponsor company and a CMO (either direction), or from one CMO to another CMO (in or out of network). It is not unusual for a product to undergo multiple tech transfers during its lifecycle.

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The Forgotten Capital Spares

By Robert Smith, May 26, 2020


Preservation Program


What are Capital Spares?

A Capital Spare is a piece of equipment, or a spare part, of significant cost that is maintained in inventory for use in the event that a similar piece of critical equipment fails or must be rebuilt.

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Achieving Capital Project Success Through Organizational Maturity

By John Hughes, April 16, 2020

Every organization has some “big problem” that they need to address. New software, sensors, equipment, or analytics can sometimes be the solution to that problem. But sometimes there is a nagging thought that the real issue is more institutional than asset-based. Almost universally, companies that successfully leap into the Internet of Things (IoT) are already mature, efficient, and agile. They don’t need to solve nagging performance issues. They aren’t looking at software as a solution or performing maintenance by capital project. They’re making a step change to maximize already satisfactory performance metrics.

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Are paper batch records slowing you down?

By Michael Morrison, March 31, 2020

HOW BATCH RECORDS ARE MANAGED

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Quick Glance: Take an Extra 5 Minutes for Safety and Quality

By Brian Nieport, March 26, 2020

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Is Rework Killing Your Packaging Line Efficiencies?

By Tammy Scott, March 6, 2020

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Can Data Centers Save the World with Renewable Energy?

By Ann Schneider, March 6, 2020

Data centers have a significant impact on the global energy market. Current global data center consumption is higher than 2% of all electricity produced, and it is projected by Greenpeace to reach 13% of global electricity demand by 2030 [1]. As a result, data center design is uniquely positioned to influence renewable generation on a global scale positively. Large players in the industry such as Facebook, Microsoft, and Google have pledged to become ‘100% Renewable’ through a collaborative global initiative called RE100 [2]. We’ll discuss: why go renewable, how was it achieved, and where are the renewable data centers located?

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Performance Improvement Strategies that WORK

By Daisy Chew, March 6, 2020

How Key Performer Interviews can help determine root causes for your performance issues and help you develop intentional improvement strategies that work.

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UPDATE: Second Stakeholders' Consultation on the Revision of Annex 1

By John Henchion, February 21, 2020

The second targeted stakeholders' consultation on the revision of Annex 1, on the manufacturing of sterile medicinal products, of Eudralex Volume 4

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Quick Glance: ICH Q10 Question Solved?

By John Henchion, February 13, 2020

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Quick Glance: Regulatory and Inspection Harmonization

By John Henchion, February 6, 2020

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Relationship Management: Why, Who, & How

By Melissa Austin, December 19, 2019

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Louder Than Words: The Key to Effective Communication

By John Krawczyk, November 26, 2019

It is a well-established maxim that "Good communication is the key to successful projects." Clear, concise, specific communication is the goal, and this applies to business as well as day-to-day life. The trouble is following through on it.

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Project Meetings Playbook: Your Map to Meeting Nirvana

By Melissa Austin, October 22, 2019

Project Team Meetings are rarely identified as a risk event for a project’s success. Yet, non-productivity during these collaboration sessions is highly probable and can be very costly.

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New PDA Resource: 2019 Technology Transfer Industry Survey

By Beth Haas, September 9, 2019

Results from the PDA survey on Technology Transfer have now been published documenting key highlights and findings from the participant response! This publication which was co-authored by one of CAI's principal consultants, Beth Haas, can be found in the PDA Bookstore.  Learn more about Beth below.

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Building Trust – Engineering to Quality/Validation

By Chip Bennett, September 6, 2019

Over the years, the roles and responsibilities of Engineering and Quality/Validation have evolved for Commissioning and Qualification (C&Q) activities. Now more than ever, risk-based approaches rely heavily on Engineering Subject Matter Experts (SMEs) and the application of Good Engineering Practices (GEPs) as an Engineering Quality Process to underpin C&Q.

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EU & US MRA Fully Operational - What You Need to Know!

By John Henchion, July 25, 2019

Background

In 1998, the EU and the US signed a broad Mutual Recognition Agreement (MRA), which included a Pharmaceutical Annex providing for anticipated and limited reliance on each other’s Good Manufacturing Practice (GMP) inspections. However, this Agreement was never fully implemented.

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Understanding cGMPs for Phase 1 Investigational Drugs

By Dan Carpentio, July 18, 2019

Everyone in the pharmaceutical manufacturing industry understands or has at least heard of current Good Manufacturing Practices (cGMP).  The requirements of the cGMPs are prescribed in Title 21 of the Code of Federal Regulations parts 210 and 211 (better known as 21 CFR part 210 and 211).  But there is a unique situation in which the requirements of 21 CFR 211 in the manufacture of a drug are exempt.  That is for the manufacture of Phase 1 investigational drugs.

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Release of 2nd Edition ISPE Baseline Guide 5 for C&Q

By Steve Wisniewski, July 16, 2019

Intro

ISPE has just released the second edition of Baseline Guide 5 for Commissioning and Qualification (C&Q) The objective of the 2019 C&Q Baseline Guide revision is to define and explain a simplified risk-based C&Q process in a single guide that meets present-day standards and provide focus to ensure a compliant, efficient, and cost-effective approach.  The revised Guide provides the current industry best practices for commissioning and qualification of pharmaceutical facilities and equipment.  It supersedes the 2001 publication and the two 2011 Guides covering Quality Risk Management/ASTM E2500 based approaches.

The new Guide provides an improved QRM C&Q process flow and recommended implementation practices with practical examples taken from the industry.

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FDA Approves Emergency IND in Less Than Three Hours

By Cheryl Bondurant, June 27, 2019

How a CAI agent helped make a difference

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How to Measure PQS Effectiveness Using the CAPA System

By John Henchion, June 25, 2019

A ICH Q10 Challenge

 

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How to Maintain Equipment Readiness During Modified or Idle State

By Nick Armstrong, June 20, 2019

A considerable amount of effort goes into developing an asset maintenance plan that combines all the technical and administrative measures throughout the life cycle of a piece of equipment aiming to preserve as well as restore its readiness so it can perform its required function. Often, the premise of these plans is that the asset is operating and mostly in a steady state. Strategies based on this premise is an incomplete approach that even the best companies fall victim to with unexpected, and at times, tragic consequences. Engineers and maintenance leaders need to ask themselves what special considerations to address when equipment is in an idle state for an extended period or operating in a reduced or modified state (such as would be experienced following new construction) before being placed into production.

 

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Managing Uncertainty and Maintaining Progress

By Robert Lucas, June 6, 2019

Imagine the following scenario: The capital project is large, multinational, and complex. It is in the early stages of the project lifecycle, and the schedule is not fully developed nor the team fully formed. Uncertainty abounds, and frustrations are building due to the perceived lack of progress. The pressure is palpable. The project has high visibility and is under increasing scrutiny from executive leadership. Their message is “We need to accelerate Phase 2” – it cannot and should not be ignored. In the midst of this, the differences of opinion within the core team on strategy and execution may be impacting progress. This scenario is not uncommon at the start of a major, complex capital project, and it is the role of the Project Manager to keep the project moving while striving to build a team of cooperative players.

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Download the Whitepaper: Power of Design Review

By Chip Bennett, May 30, 2019

Design Review (DR) and Quality Risk Management (QRM) are considered current industry practice and are essential as enabling processes for verification of facilities, systems, and equipment. But what is Design Review? Why is Design Review underutilized in CQV projects? What are the risks of not performing Design Review? And more importantly, aside from regulatory expectations, what are the benefits of performing Design Review?

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C&Q Benchmarking: Process and State of the Industry

By Nathan Temple, May 17, 2019

Risk-based approaches to commissioning and qualification (C&Q) is a common standard for site and project plans. What does that mean and why is there so much implementation variability across the industry? Our CQV benchmark initiative is focused on:

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Whitepaper: Strong Project Controls are Critical to Your Success

By Jess Porter, April 30, 2019

Here's an excerpt from this whitepaper: "The hallmark of a high performing organization is the cultivation, use, and continuous improvement of their processes used to monitor and evaluate performance. As such, many organizations continue to struggle to reach a high level of performance in delivering projects, not because they don’t have project management processes, but because these processes fail to identify, track and act upon project data which indicate project health – both good and bad. Additionally, these organizations fail to use lessons learned from one project to improve their project management practices in subsequent projects.

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Batteries & Flywheels: What is your best energy storage option?

By Ann Schneider, April 25, 2019

A mission critical facility’s greatest liability to maintaining uptime is power quality. But why is power quality so important to a Data Center’s operation? Because the quality of power to the IT equipment directly impacts the equipment performance, uptime, and potential damage to equipment. The key to power quality is choosing the right uninterruptible power supply (UPS) for the facility’s application. This post will focus on two different UPS technologies: battery and flywheel. The operational principle of a flywheel is a mechanical energy storage device that utilizes rotational momentum inertia to store and deliver back energy. Conversely, a battery is a chemical energy storage device that delivers and recharges by execution and reversal of a chemical reaction. Currently, the battery UPS is the most common energy storage technology with the most common battery type being lead-acid [1]. In this post, we will examine the benefits and shortfalls of each technology to identify their best application scenarios. Categories to be considered are the installed size, energy storage capabilities, lifespan, operating conditions, efficiency, and carbon footprint.

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Can Data Centers Save the World with Renewable Energy?

By Ann Schneider, April 23, 2019

Data centers have a significant impact on the global energy market. Current global data center consumption is higher than 2% of all electricity produced, and it is projected by Greenpeace to reach 13% of global electricity demand by 2030 [1]. As a result, data center design is uniquely positioned to influence renewable generation on a global scale positively. Large players in the industry such as Facebook, Microsoft, and Google have pledged to become ‘100% Renewable’ through a collaborative global initiative called RE100 [2]. We’ll discuss: why go renewable, how was it achieved, and where are the renewable data centers located?

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What do LEED® and CAI have in common?

By Carla Carrasquillo, April 18, 2019

Have you wondered what LEED® means, and why it has become such a widely used term?

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The Edge of Modular Data Centers

By Camelia Mititelu, April 9, 2019

The expansion of edge computing, powered by the Internet of Thing’s (IoT) uprising tide, brings the unique opportunity to turn a world full of data into a data-driven world. Many applications of IoT, such as industrial automation processes, smart healthcare, and self-driving cars, require a compute infrastructure that sits closer to the devices and users, to enable a quick response and to unload some of the processing work from the cloud centralized platforms. The same data center that reduced its footprint and migrated into the cloud a decade earlier is now returning to the network edge. According to research firm MarketsandMarkets, the edge computing market is expected to surge from $1.47 billion in 2017 to $6.72 billion in 2022, at a compounded annual growth rate of 35.4 percent. To this end, the innovation effort at the edge brings new products and services.

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Whitepaper: Funding Building Commissioning Efforts

By Jay Congdon, March 14, 2019

This whitepaper examines "The Capital Project Model - Limitations, Pitfalls, and Short Comings"  as it related to Building Commissioning efforts as well as "An Alternative Method - Combined Funding, Benefits, and Advantages."

 

Written by Jay Congdon, CEM, CEA, CBCPM, CBCP, EBCP, CMVP

Jay has 12 years of experience providing Building Commissioning and Energy Engineering services for new and existing buildings. He also has 21 years of service in the Navy performing engineering duties as a nuclear trained machinists mate serving as operator, maintenance technician, and supervisor and instructor on active submarines and on operational training platforms for enlisted personnel and officers in the nuclear power training program.

Jay also has 16 years of experience in GMP manufacturing facilities performing commissioning, validation, and quality department support services for manufacturing areas, facilities, and utilities in new and renovated facilities, for upgraded processes, new equipment, and modified equipment. He has extensive qualification work for clean rooms and environmental controls systems.

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What does it take to inspire people to work safely?

By Michael Martin, January 29, 2019

Having led many large capital projects around the world that had very strong safety records, I was asked by an HSE leader about my approach for creating and inspiring a strong safety culture... this was my response:

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5 Factors in Choosing a Partner Firm to Accelerate Speed to Market

By David Shenberger, January 24, 2019

In the biotech industry today, mergers, acquisitions, and joint ventures are announced daily. Startup companies with viable molecules must decide early how they get a drug into trials, and eventually to the marketplace, as rapidly as possible. Contract research organizations (CROs), contract development and manufacturing companies (CDMOs), and dedicated contract manufacturing organizations (CMOs) all offer options for the specific expertise needed to complete the research, product development, and process development necessary to successfully manufacture a new drug entity.

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Whitepaper: 6 Mistakes Made When Implementing Serialization

By Brian Stephens, January 22, 2019

The FDA’s 12 month delay in enforcing the Drug Supply Chain Security Act (DSCSA) requirement for all RX products in cases to be serialized was meant to give industry more time to comply with the new regulation, but this extra time does not modify the Act or change the enforcement date of its later provisions.  The extra time may seem sufficient for companies who have delayed their serialization efforts, but many companies are finding serialization to be more involved than they expected, as they encounter unforeseen issues and delays during several phases of their project.  These problems have several causes, including the immature technology being used, the miscalculation of resources required to implement the system, and the failure to identify the system’s true capabilities until it is too late.  This whitepaper discusses common mistakes made before, during, and after the implementation of a serialization system and offers ideas to minimize or eliminate the problems associated with adding serialization to a supply chain.

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Are you too busy to fix your organization's asset management problems?

By John Hughes, January 8, 2019

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The Top 2 Elements of FAT Planning

By Keith Weseli, December 13, 2018

 

Your equipment is ordered.  The schedule is set.  The team travel plans are made. But are you ready to maximize your experience at the original equipment manufacturer’s factory floor?  This post will review some key points to consider in maximizing the Factory Acceptance Testing (FAT) as part of the overall verification process.

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Are paper batch records slowing you down?

By Michael Morrison, November 13, 2018

How are batches managed?

 

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2018 ISPE Annual Meeting Speakers

By Jennifer Lauria Clark, November 1, 2018

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Cloud Computing in a Regulated Environment

By John Hannon, October 25, 2018

How can cloud computing be used in a highly regulated environment?

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Equipment Reliability and Preserving Functional Requirements

By John Hughes, October 23, 2018

Pharmaceutical companies make huge investments in equipment, materials, and personnel to develop and manufacture life-saving products. The equipment that makes those products is designed, manufactured, and commissioned to a specific set of standards. There is an expectation that the equipment will continue to provide quality service within those parameters for a set amount of time and for a predictable cost. Yet we struggle to have confidence that our operational and capital expenditures will return the maximum value from our assets from the day they are qualified until their disposal.

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Improving Supply Chain Through Human Performance

By Rich Tree, October 18, 2018

In many ways, today's pharma and biotech facilities share the same problem that many of the factories that supported the war effort during World War II had – a shortage of skilled and qualified operators and technicians. This lack of a skilled workforce in the early 1940’s was a crisis that the U.S. Government War Production Board responded to quickly with one of the first emergency services to be established: Training Within Industry or TWI. As many skill laborers went off to war, the service was designed to boost industrial production of war material born out of the need to rapidly train new, unskilled workers entering the war production workforce. The impact of TWI was instrumental to the United States’ victory in World War II, but it also had a far-reaching impact on the post-war rebuilding of Japan. Although this program was built on long accepted principles, it was very effective because managers and supervisors were “drilled” in “how to do it."  It began with the recognition that the organizational environment and the organization’s management systems had to establish the framework by which humans are expected to succeed. TWI worked to solve a problem that the nation faced in the 1940’s by focusing on training unskilled workers and minimizing human error, and this remains the objective for the pharma and biotech workforce today.

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Does your project team have a common vision and goal?

By Michael Martin, October 16, 2018

Sometimes projects are conducted as a series of disconnected efforts where each team from planning, design, construction, and testing views themselves as separate entities. With each trying to finish their portion of the work and get on to their next project. These “separate” efforts have goals to accomplish, and sometimes they regard each other as the obstacle to accomplishing those goals. The downstream team often feels that the upstream team doesn’t understand the difficulties they are experiencing and that they are just trying to throw the work product over the wall and claim success. The upstream team feels that the downstream team is too demanding and will not accept something less than perfection. Conflict ensues, and the overall program suffers. 

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AAV Vector Production

By Robert Ossig, September 4, 2018

Overview

Until about 2016, the majority of vectors used in gene therapy were Adenovirus and Retrovirus vectors.  In recent years, a change toward Lentivirus and Adeno-associated virus (AAV) vectors has occurred.  This is reflected when looking at the numbers in current clinical trials underway in the gene therapy field.

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Empowering Your Operators to Lead Can Reduce Losses

By Rick Jones, July 5, 2018

 

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Visit us at Table 9 at PDA EU Annual Meeting

By John Henchion, June 22, 2018

 

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What is Proactive Commissioning?

By Glenn Wallace, June 7, 2018

In Maintenance and Reliability, there are a complete set of tools dedicated to Proactive Maintenance.

 

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Predictive Maintenance Technologies

By Glenn Wallace, June 5, 2018

Predictive Maintenance (PdM) technologies are not just for use after your equipment has been installed.  Many of these technologies can be applied during the various stages of your commissioning activities.

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Human Error and Uncertainty

By Harry Benson, May 31, 2018

Why competent people make costly errors, and how to address it.

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Commissioning Teamwork

By Niall Killeen, May 29, 2018

How to best develop good teamwork across the General Contractor, subconsultants, CxA, and Operations during a project.

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Why Implement Total Productive Maintenance Autonomous Maintenance

By Rick Jones, May 24, 2018

 

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E-Pub: The Importance of Annex 1

By John Henchion, May 21, 2018

Annex 1 - "Manufacture of Sterile Medicinal Products." was first published in 1971. However, the first revision since then is currently in process. And this revision will have impact way beyond the EU borders.

World Health Organisation (WHO-all United Nations are members) and Pharmaceutical Inspection Co-operation Scheme (PICs) are actively involved in the update of Annex 1. The guidance is being developed with global harmonization of standards in mind.

Click below to view the full brochure on our understanding and capabilities surrounding the changes to come with this update:

Click Here to Read our E-Pub on our Understanding of Annex 1

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Why I Chose CAI to Incubate and Accelerate my Career

By R. J. Filannino, April 13, 2018

I have two guiding principles that I rely on when making career decisions. Compounding experience and future opportunity.

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Moving the Goalposts?

By John Henchion, April 5, 2018

Can a standard Corporate Scoring Framework be applied across the spectrum of Quality Risk Management?

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Int'l Women's Day: An Open Letter to my Most Inspirational Colleague

By Sarah Patterson, March 7, 2018

Have I ever told you how much I want to be just like you? I am so thankful for the opportunity to work alongside the ultimate colleague, mother, friend, partner, and party guest. You teach me to strive for the things I’ve always dreamt of and only focus on the things that actually matter. From the moment I met you, I looked up at you as a role model.

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Performance Improvement Strategies that WORK

By Daisy Chew, March 6, 2018

How Key Performer Interviews can help determine root causes for your performance issues and help you develop intentional improvement strategies that work.

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In Review: Facilities of the Future Conference

By Robert Chew, February 27, 2018

ISPE held its second Facilities of the Future conference.  The conference brought together over 160 professionals from pharmaceutical and biotech manufacturing, equipment suppliers, academics, and regulators.  Jim Breen, Vice President Lead Biologics Expansion, Janssen Pharmaceuticals, was the Program Planning Chair.  

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Data Centers are Constantly Evolving

By Jennifer Lauria Clark, February 7, 2018

Growing up, we did not have a home computer in my family until I was 11 years old. We were fortunate enough that my momma brought home an Apple desktop over the summer; my sister and I dedicated all of our computer time to Oregon Train and Number Munchers. (“Like” this post if you remember those games on 3.5 x 5 floppy disks!)

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The Low Down on a New Packaging Serialization Standard

By John Hannon, January 4, 2018

Nine vendors and one end user recently conducted pilot tests to develop, evaluate, and validate a new serialization standard, PSS 1.0, officially released in November 2017. This group, known as the Open Serialization Communication Standard Group (Open-SCS), advocates that PSS 1.0 minimizes customization of plant-to-enterprise interfaces (Levels 3 and 4), thereby shortening the integration process by months and improving scalability and repeatability.

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Training [Usually] Isn't the Answer

By Daisy Chew, December 5, 2017

How a knee jerk reaction can waste time, money, and leave the problem unsolved.

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Applying Six Sigma Principles to Operations: The Voice of the Customer

By John Krawczyk, December 1, 2017

What is the “Voice of The Customer”? Is it only external customers? The end users? What about internal customers? Do they have a “voice” as well? Who are the “Customers” anyway?

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Applying Six Sigma Principles to Client Operations: Waste

By John Krawczyk, November 30, 2017

Waste shows up in many forms and in all projects. This happens regardless of industry, product, or service being provided. Nothing is perfect, no matter how hard we try. That doesn’t mean that the effort to reduce waste is for nothing. Anytime waste can be removed from a product or process is a plus regardless of how big or small.

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Applying Six Sigma Principles to Operations: The Cost of Poor Quality

By John Krawczyk, November 29, 2017

The principles and methodology of Six Sigma are applicable to multiple industries and processes. In all cases, the primary reason these principles are implemented is to eliminate errors, to the greatest extent possible, before they happen. The only way to accomplish this is by starting with an honest assessment of the process, locating the source of the error(s), and making needed correction(s) there. By implementing solutions upstream, where the errors occur, the client will realize much greater confidence in the quality of the final products being sent to the customer. The “quality” of the final product is what the customer is paying for. Quality in this case refers to: safety, price, availability, usefulness, and effectiveness in filling the need(s) that the customer has. All these requirements must be met for the product to be successful. If it’s not safe, why buy it? If it’s too costly or not available, alternatives will be found. If it’s not useful in solving the issue, the customer won’t want to pay for it. So, why buy it?

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Implementing USP Visual Inspection Requirements

By Eamonn Vize, November 21, 2017

The word “visible” in the expression, Visual Inspection of Parenteral Products, has no meaning unless the viewing conditions are specified. 

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Key Takeaways from the 2017 ISPE Annual Meeting

By R. J. Filannino, November 17, 2017

 

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Consider New Options

By Dan Mummey, November 15, 2017

Why work at CAI?

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The Most Important Thing That You Don’t Think Affects You!

By Lou Traglia, November 10, 2017

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Is Rework Killing Your Packaging Line Efficiencies?

By Tammy Little, November 7, 2017

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Let Others Make the Mistakes – It is More Efficient

By Glenn Wallace, November 2, 2017

Lessons Learned in Construction

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First 100 Days of a Capital Project

By Bill Deckert, October 31, 2017

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Own Who You Are: Women in Pharma

By Jennifer Lauria Clark, October 27, 2017

On Sunday I will have the pleasure of facilitating a spotlight session on “The Women in Pharma” at the ISPE Annual Meeting in San Diego, California.  We will be meeting from 1415 – 1515 to participate in round table discussions focusing on ourselves.  We will cover topics on leadership, higher education, technical aptitudes, and others that will help you evaluate your current position through your journey of professional and personal growth.  Each of our round tables will answer different questions, but this one will be asked at every table – “What guides your approach to leadership, and how do you encourage your team to be motivated and inspired?”

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Five Keys to Manufacturing Success

By R. J. Filannino, October 26, 2017

"...there are five dominant management systems required to achieve manufacturing performance.... Each element drives an important priority within the organization. An imbalance in any direction will create a gap and introduce unnecessary organization variation, impacting product quality."

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Training [Usually] Isn't the Answer

By Daisy Chew, October 24, 2017

How a knee jerk reaction can waste time, money, and leave the problem unsolved.

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Facilitation is the Key to Successful FMEAs

By Robert Smith, October 19, 2017

The Failure Modes and Effects Analysis (FMEA) is a versatile risk management tool that has been around for several decades, first used by the US Armed Forces in 1949. It started gaining popularity in the 1960’s with its use in the aerospace industry during the Apollo missions. FMEA has been called the “swiss army knife” of risk management. FMEA is focused on problem prevention, rather than problem solving. It is used to identify the factors that can lead to failure and recommend mitigation strategies to prevent failures or detect the early onset of failures.

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GEP In Projects – To Practice, Or Not To Practice?

By Bob Perry, October 17, 2017

As responsible Project Managers, we need to deliver maximum benefits realization to our project stakeholders on each project.  The key to maximum benefits realization is clearly delineating stakeholder requirements and assuring these requirements are satisfied throughout the project lifecycle.  A critical component for assuring stakeholder requirements are satisfied is following good engineering practice (GEP).  While GEP is an expectation in the life sciences industries, the basic GEP elements required as a basis for GxP (good “anything” practice) quality guidelines and regulations compliance can, and should be, applied to all projects.

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I Stuck my Hand in the Stopper Bowl

By Daisy Chew, October 12, 2017

A tale of why read and acknowledge is a failed method of operator training.

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The Data Life Cycle

By John Hannon, October 10, 2017

The ISPE Good Practice Guide on Records and Data Integrity defines a data life cycle consisting of:  Creation — Processing — Review, Reporting, and Use — Retention and Retrieval — Destruction

A robust data integrity program ensures data integrity across this entire life cycle. Such a program would include a risk-based analysis of all data flows to identify, assess, mitigate, and communicate potential data integrity issues. Systems supporting the data integrity should be validated for their intended use, and boundaries for the data should be identified. Throughout the data process, data must be secured from modification or deletion by unauthorized personnel, and changes to the data must be captured in audit trails or through appropriate procedures.

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What do NASA Missions and Pharmaceutical Manufacturing have in common?

By Dan Miller, October 5, 2017

NASA recently ended a 20 year 5-Billion-mile space journey as its Cassini space probe burned up in Saturn’s atmosphere (NASA.gov Cassini Mission Site). This $3.26 billion joint venture with ESA (the European Space Agency) opened our eyes to the ringed planet. Completing the mission was no small feat, and the 260 scientists as well as the thousands of engineers and project managers responsible will go largely unnamed. Recognition from fellow colleagues and a nod from the general population is likely all this successful group will receive. It’s hard to show gratitude for something difficult to understand. For the majority of the group, their work began several years before launch in the design and planning phases. They had to determine exactly what they needed to accomplish and then set out to achieve established objectives. They would look to off-the-shelf solutions as well as rely on their skills, experience, and education to bridge any gaps in technology. Technology that had to perform flawlessly for 20+ years. No stopping by the parts room to make a repair or having the OEM supply a needed hardware upgrade.

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Are You Ready? Major Changes Coming to Europe MDR and IVDR

By John Henchion, September 28, 2017

Introduction: One of the major focuses this year at the RAPs Convergence in DC was implementation timelines for the EU Medical Device Directive and the In Vitro Device Regulations.

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Spare Parts: The Hidden Cost of Maintaining Equipment

By Erik Zengel, September 26, 2017

 

If you own or manage any equipment, you maintain an inventory of spare parts. How have you determined what to keep in your warehouse?

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From Dragon to Chameleon

By John Hannon, September 21, 2017

Implementing a Serialization Database Across an Entire Enterprise.

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Maximizing the Impact of Factory Acceptance Testing

By Keith Weseli, September 19, 2017

 

Your equipment is ordered.  The schedule is set.  The team travel plans are made. But are you ready to maximize your experience at the original equipment manufacturer’s factory floor?  This post will review some key points to consider in maximizing the Factory Acceptance Testing (FAT) as part of the overall verification process.

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Where to Draw the Line?

By John Henchion, September 11, 2017

What is an appropriate level of GMPs for a supplier manufacturing site?

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Optimizing Time to Market

By David Shenberger, June 20, 2017

In the biotech industry today, mergers, acquisitions, and joint ventures are announced daily. Startup companies with viable molecules must decide early how they are going to get a drug into trials and eventually to the marketplace as rapidly as possible. Contract research organizations (CROs), contract development and manufacturing companies (CDMOs), and dedicated contract manufacturing organizations (CMOs) all offer options for the specific expertise needed to complete the research, product development, and process development necessary to successfully manufacture a new drug entity.

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All Hands Topside for Stores Load

By Glenn Wallace, August 22, 2016

 

Below are typical pictures of how food and parts are loaded on a submarine prior to deployment.  Yes, it is a very manual and laborious job and often requires crew from multiple departments of the boat.

 

 In civilian industries, it is not quite that difficult to load parts into the warehouse.  But often times, many of those parts in the warehouse can be critical to the success of your organization when a component goes down and it takes your entire processing line with it.

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How do you develop your organization’s maintenance program?

By Glenn Wallace, August 18, 2016

 

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Maintenance & Reliability: Goldilocks and the Three Bears

By Glenn Wallace, August 11, 2016

Like Goldilocks, most of us are trying to find that reliability program that is “just right” for all of our equipment and processes.

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20 Years of Meeting a Higher Standard

By Tim Howard, April 19, 2016

Commissioning Agents, Inc. (CAI) was founded with a mission to become the world wide leader of value-added commissioning services for Biopharm facilities and to be an agent for change in the industry.  On the occasion of our 20-year anniversary, we celebrate our past and provide a vision for the next 20 years.

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Help The OEM Help You. Better Designs From Suppliers With In Depth RFI

By Marie Getsug, April 15, 2016

Identifying Original Equipment Manufacturers (OEMs) with the capabilities and experience to design, build and deliver physical assets that perform beyond stakeholders’ expectations is an important initial step in delivering a successful project. Yet when tunnel vision sets in at this early phase of concept and design and firms begin focusing in on the traditional metrics of initial costs, scope and schedule to define a project, the opportunity to raise the bar on obtaining the lowest possible life cycle costs (LCC) through improved long-term performance is often lost before it’s even defined.

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Serialization: Are You Ready For Changing Regulations?

By John Hannon, April 12, 2016

If the pharmaceutical distribution network is at risk, so is patient safety. With counterfeit drugs on the rise, serialization programs are being implemented to safeguard the integrity of product reaching the market. Serialization also provides better controls to communicate recall information should it become necessary.

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Do You Have Rouging Problems?

By Nissan Cohen, April 10, 2016

Recently rouging of two process vessels at a blood fractionation facility shut down production. 

The tanks of concern were derouged and passivated just 10 days before the rouge was observed on product contact surfaces prompting great concern.

The tanks are configured with baffles and stirrers connected to a main shaft.  “Staining” was noticed by the operators on several of these product contact surfaces.

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