Ever Heard About Extreme PHARMACEUTICAL WATER SYSTEMS? Well About That…

If there is one reason for which laboratories, utility operations, and production have to invest huge expenditures and effort on items such as labor for system sanitization and additional testing and quarantines of whole systems or specific outlets; it has to be water system microbial excursions. Poorly executed water system microbial excursions can also lead to losses when they invite investigations and can also lead to potential costs associated with product rejections where root causes are not definitive.

Long road to developing mutual communication

While it is true that some excursions are genuine and result from system control problems, most are usually self-inflicted. They can be caused by factors such as poorly designated “trigger values”, badly designed use points, or poorly executed sampling or testing. How do pharmaceutical water systems organizations overcome issues such as this?

The ways of doing this will be taught at a 90-minute webinar that Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing on April 16. The guru of pharmaceutical water systems, Teri C. Soli, will be the speaker at this important presentation. Please log on to https://t2m.io/itHNR1Od to enroll for this webinar.


The core learning that this webinar will impart will help participants explore the possible causes, including the symptoms of real, as well as false, water system problems, and will provide effective alternatives to avoiding most of their current superfluous excursions. It will show them how to build supporting data that will become useful in pinpointing causes when investigations are indeed necessary.

Dr. Soli will help participants understand the most common causes of microbial excursions in water systems and how they can easily be avoided with minimal effort. He will cover the following areas at this session:

  • What are excursions?
  • Water system dilemma: process control or quality control (utility or raw material), or both
  • Intended functions of Alert/Action Levels and Specifications
  • Investigation, necessary and often fruitless
  • Excursion responses and impact
  • Criticality of valves, hoses, & outlet flushing
  • Diagnosing the source of the problem
  • Minimizing unnecessary excursion responses through best practices.

This webinar is of immense value to:

  • QA managers and personnel involved in investigations of excursions and preparing CAPAs
  • QC managers and personnel involved in sampling, testing, and trending chem and micro data from water systems
  • Utility operators and their managers involved in maintaining and sanitizing water systems
  • Validation Managers and Personnel
  • QA Managers and other Personnel involved in Change Control programs
  • QA Managers and Regulatory Affairs personnel involved in defending water system operations and Quality Data to FDA and EMEA Inspectors and outside Auditors
  • Consultants and Troubleshooters.


About the speaker: Dr. Teri C. Soli is a microbiologist and President of Soli Pharma Solutions, Inc., which offers troubleshooting and training expertise covering water systems, sterilization, sterile and non-sterile manufacturing, microbiological laboratories, and microbial and beta-lactam contamination control.

Dr. Soli is a recognized global expert in contamination and biofilm control in the biopharmaceutical, medical device, and personal care product industries. He has authored numerous articles in Pharmacopeial Forum, Pharmaceutical Engineering, and Pharmaceutical Technology and other publications, and has authored chapters in many books and industry guides published by PDA and ISPE.


Need More Time? Read These Tips to Improve [Pharmaceutical Clean Rooms]

HVAC systems that meet the required regulatory particulate and microorganism levels that help meet quality requirements in the pharmaceutical product.

The proper and thorough understanding of the way in which a clean room’s HVAC system is designed and validated is critical for pharmaceutical professionals. This paves the way for creating the environmental control, a precondition for meeting the regulatory particulate and microorganism levels that are necessary for manufacturing a pharmaceutical product that meets quality expectations and requirements.

This makes environmental control of pharmaceutical clean rooms an indispensable element in the manufacture of a quality product. A webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will explain how to set the right conditions to obtain a cleanroom’s HVAC systems that meet the required regulatory particulate and microorganism levels that help meet quality requirements in the pharmaceutical product.

This webinar, at which Roger Cowan, who is the founder and owner of R Cowan Consulting Services LLC will be the speaker, will be of 75 minutes’ duration and will be organized on March 18. To know more about how to improve pharmaceutical cleanrooms, please register for this webinar by logging on to https://t2m.io/Yn3dLyqB.

The main objective of this webinar is to underscore the criticality of the design, validation and ongoing monitoring of a clean room HVAC system in assuring both the quality and safety of the pharmaceutical product and to create a clean room environment that meets the compliance requirements set out by international regulatory standards.

Roger will explain Environmental Control vs. Environmental Monitoring, since the control of conditions such as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is vital to ensure the protection of the product from contamination.

He will also take up the various US and international regulatory requirements for various clean room classifications and then move on to comprehensive overview of the mechanics of clean room HVAC. He will reinforce the learning in this section by including engineering diagrams and schematics. Apart from detailing the HVAC equipment components and the automated control systems that are available, the speaker will also explain clean room design considerations. He will also emphasize the importance of proper building construction and layout for achieving both optimum efficiency of the system and optimum cleaning and sanitization of the clean room.

At this session, Roger will cover the following areas:

  • GMP Compliance of Clean Room Environment
  • Regulatory Clean Room Classification and Requirements
  • HVAC System Components
  • Clean Room Design and Layout
  • HEPA Filtration
  • Differential Pressure and Air Pressure Balancing Considerations
  • Temperature and Humidity Controls
  • Cleaning and Disinfection
  • Personnel Gowning and Aseptic Practices in Clean Room
  • HVAC System Validation.

This session is of high value and importance to professionals who work in cleanrooms, such as Quality Assurance, Environmental Monitoring, Microbiology, Manufacturing, Validation, Engineering and Maintenance.


About the speaker:

Roger Cowan brings 37 years of experience in pharmaceutical quality assurance and manufacturing. His company specializes in consulting primarily in the area of pharmaceutical contract manufacturing. His areas of expertise include: aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US/International regulatory requirements, regulatory submissions, and quality assurance/control.

New Easy Ways to Learn Everything About Quality by DESIGN PROGRAM

Quality risk management and product process control are core components of QbD.

Quality by Design (QbD) is a Quality approach that relates to the ability of a pharma product to meet its quality requirements. In order to understand this concept, we need to first get a simple understanding of the meaning of quality in the context of the pharmaceutical industry. It means the ability of the pharmaceutical product to consistently deliver a pharma product that is free of contamination and meets the expectations of the consumer by offering the therapeutic value as defined in the product’s label. This has to be assured through a set of reproducible methods. The most common among these are in vivo and in-vitro methods.

QbD is a systematic approach to the process of ensuring quality in the pharmaceutical product. It seeks to meet predefined quality goals and objectives by employing the methods used in sound science. Quality risk management and product process control are core components of QbD. These are some of the goals that pharmaceutical QbD seeks to achieve:

  • Meaningful product quality specifications that are built on the foundation of clinical performance
  • Boosting the design, understanding, and control of the product and process with the aim of increasing process capability and reducing product variability and defects
  • Augmenting the efficiencies of product development and manufacturing
  • Bettering root cause analysis and post approval change management.


QbD professional seek to achieve these goals through a twofold approach by which they:

  • Link the product quality to the desired clinical performance
  • Design a vigorous process of formulation and manufacture, which makes it possible for them to deliver the product with the desired product quality, consistently.

Now, new easy ways to learn everything about Quality by Design program

Applying the principles of a QbD approach can benefit the pharmaceutical companies immensely. By implementing these principles, they can bring about a measurable improvement in their manufacturing efficiency and can promote innovation. Yet, implementing these principles into the pharmaceutical development culture can be challenging for an organization, since QbD involves a complex set of interactions, technologies and systems that are not easy to grasp.

All these seemingly complex concepts need not befuddle you. Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic of new easy ways to learn everything about Quality by Design program. Compliance4All brings the highly experienced Quality professional, Steven Laurenz, as speaker of this valuable, hour-long session.

Please visit https://t2m.io/ffxwM3Ha to enroll for this highly meaningful learning on how to initiate and maintain a healthy QbD program that satisfies the requirement set out by the regulations in this field.


The core of this training session is the understanding Steven will give of all the aspects of QbD, such as what it means, what benefits your organization can gain by applying a QbD approach, and what tools can be employed to implement a sound QbD approach. He will offer key steps for achieving this.

Core topics concerning QbD, such as the target product quality profile, risk assessment, methods to establish a design space, and design of a control strategy will be covered. The aim of offering an understanding of these topics is to help bridge the gap between understanding the principles and applying them practically.

This session is of immense use to those who are involved in the QbD process, and these include Process Owners, Quality Auditors, Quality Engineers, Quality Professionals, Production Engineers, Production Supervisors, Senior Quality Managers, Regulatory Professionals, Manufacturing Engineers, Compliance Professionals, Development Professionals, and Senior Development Managers.

At this webinar, Steven will cover the following areas:

  • Using Models
  • Risk Assessment
  • Control Strategy
  • Design of Experiments
  • FMEA and Control Plan
  • Developing a Design Space
  • Target Operational Profile
  • Process Analytical Technology (PAT)
  • Quality Target Product Profile (QTPP).


About the speaker: Steven Laurenz brings a quarter of a century of experience in technical leadership, which has included areas such as product development, process development, technology transfer, and process optimization.

Steven is skilled in taking new products from early laboratory stage to successful manufacturing launch and is an expert in integrating Quality by Design and risk management into product development.



Trial Registration and Results Reporting on ClinicalTrials.gov

Guidelines to identify operational processes and best practices to register clinical trial, provide updates in a timely manner and file final reports

The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to ClinicalTrials.gov, in accordance with Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801).

The Final Rule has been in effect since January 18, 2017. The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition of the publication of research results generated by a clinical trial. To fulfill this obligation organizations and individuals can provide the World Health Organization (WHO) Trial Registration Data Set required by ICMJE to ClinicalTrials.gov or a WHO primary registry.

The ICMJE expects authors to meet all results reporting requirements of their funding and regulatory agencies. If there are no such reporting requirements, the ICMJE encourages authors to submit results information to the same database on which their trials are registered.

In this session we will review the challenges clinical teams and sponsoring organization face in determining if a clinical trials are qualified and required to be registered, and discuss time frame for updates to be posted and reporting of the results to be completed.

This session will explore the challenges clinical teams and sponsoring organization face in determining if a clinical trials is qualified and required to be registered, determining time frame for updates to be posted and reporting the results.

Registration and summary results reporting of clinical trials has two main purposes: to inform potential subjects, and to increase transparency of conducted clinical trials and the likelihood that negative results of trials will be publicized. The U.S. Government site for registering clinical trials is ClinicalTrials.gov. A study is issued a CT.gov NCT registration number when it is registered. A trial only needs to be listed once.

For investigator-initiated clinical trials, the Principal Investigator is considered the Responsible Party, and is the one who has to complete the registration. For multi-center clinical trials, someone other than the local PI usually fulfills this responsibility (i.e. the Sponsor).

The Responsible Party who initially registered the clinical trial is also the one who must maintain the information about the trial, including updating recruitment information at least every 12 months and reporting final results.

This webinar is very much essential for Professionals involved in a clinical trials, either as a clinical site or a sponsor/CRO as it will provide valuable suggestions about which documents are essential according to FDA requirements for drugs, biologics and medical devices.

The instructor will discuss common deficiencies identified by FDA auditors during review of TMFs and provide potential solutions and best practices of implementation related to set up, maintenance and quality control of the TMF for drugs, biologics and medical devices.

  • Discuss key factors to consider, when deciding if its qualified clinical trial
  • Review rules, policies and guidelines to identify operational processes and best practices to register clinical trial, provide updates in a timely manner and file final reports
  • Review “Summary of HHS Final Rule and NIH Policy on Registration/Reporting in ClinicalTrials.gov”in NEJM (Nov. 2016)
  • Provide overview of registration process on Clinicaltrial.gov website
  • FDA’s expectation for clinical site and sponsor’s essential regulatory documents
  • Required components of a TMF
  • Best practices for the set-up and maintenance of TMF
  • Electronic and Paper TMF requirements
  • Common discrepancies in TMF management

Want to Have a More Appealing FDA CFR 21 Part 11? Read This!

The most important ones among these are Computer System Validation, data security, and data backup.

Title 21 CFR Part 11 is one of the sections of the FDA that inspires both awe and respect. Commonly known as 21 CFR Part 11, this section deals with and establishes the criteria for the FDA’s requirements relating to electronic records and electronic signatures (ER/ES). All the requirements which the FDA expects for electronic records and electronic signatures to be considered trustworthy, reliable and equivalent to paper records are set out in this section.

For the FDA to consider electronic records, electronic signatures and handwritten signatures to be on par with handwritten ones and proven for their safety, trustworthiness and authenticity; companies in the designated industries governed by FDA regulations have to meet conditions set out in 21 CFR Part 11. It is only when these conditions are met that the FDA considers these records to have the same effect or worthiness of an actual paper record.

As paper made way for electronic versions with the advent of technology; FDA 21 CFR Part 11 regulations evolved with the intention of helping to overcome some of the obvious drawbacks of paper records:

  • Their potential to be manipulated or forged
  • Their destructibility
  • Lack of authenticity.

FDA 21 CFR Part 11 regulations came into being to give electronic signatures the same effect as those of paper ones. These regulations seek to make the electronic signatures as authentic as the paper records they replace through a set of well-defined scientific means. FDA 21 CFR Part 11 is designed to give regulatory authorities the confidence and scientific validation for this authenticity.

The core areas of 21 CFR Part 11 implementation

21 CFR Part 11 regulations compliance covers three core areas:

Standard Operating Procedures

There are nearly 12 Standard Operating Procedures prescribed in the 21 CFR Part 11 regulations for addressing the company’s IT infrastructure. The most important ones among these are Computer System Validation, data security, and data backup.

System features

21 CFR Part 11 regulations require close to 50 industry-related features that organizations need to implement into their computer systems to be compliant with the regulations.

Computer System Validation

The core of 21 CFR Part 11 regulations is Computer System Validation. The purpose of implementing CSV is to ensure that the FDA has documented evidence that each computer system in the organization carries out exactly what it is expected to and helps users detect and identify errors.

How to make your 21 CFR Part 11 effective

Since implementation of 21 CFR Part 11 is mandatory in the industries for which it is stipulated; it is necessary to those who work in these industries to get a proper and thorough idea of how to properly implement the provisions of this regulation.

Adapt a risk-based approach. This is the foundation to 21 CFR Part 11 implementation 

The basis to effective implementation of 21 CFR Part 11 is to take a risk-based approach to implementation. A risk-based approach should take all the possibilities of risk into the area of electronic signatures and work on ways of countering them. Understanding the risks is the foundation to implementing 21 CFR Part 11 effectively, as it helps to identify areas from which risk could arise to the electronic signatures.

The risk-based approach is not only a very solid means to ensuring the effectiveness of 21 CFR Part 11 regulations; it also prevents the organization from being cited by the FDA, since this is the method the FDA itself suggests and welcomes. It is also extremely useful in making the organization’s computer systems more effective and inexpensive over time.

Train your staff

The key to effective and proper 21 CFR Part 11 implementation is for the organization to let its employees know the importance of this regulation. It is only when employees, as stakeholders in the organization’s growth, are enlightened about the importance of critical regulations such as 21 CFR Part 11 that they understand why they need to implement, what benefit they get out of implementing it, and what they stand to accrue in terms of penalties for lack of implementation that they take a keen interest in its implementation.

Again, training too, is a core FDA requirement. The FDA has laid out clear-cut guidelines of how to train employees for 21 CFR Part 11 implementation and the ways of documenting the training. Organizations that comply with these requirements are less likely to invite FDA actions.

The most incredible technology you’ve never seen

The biological world has already demonstrated what’s possible on this scale — if we’re going to aim big as a species, it’s time we think small.

There’s money to be made and lives to be saved with the tiny stuff that’s all around us.

Saving the world (or some subset of people in it) is in vogue among the world’s wealthiest.

Jeff Bezos has a rocket company, Blue Origin. Bezos believes our future is extraterrestrial, and his rocket company exists because he thinks the price for getting anything off this rock is too damn high.

Bezos is not alone. Elon Musk is also building huge, reusable rockets. He wants to see humans fly to Mars, initially on a lark but eventually for forever.

This type of long-term thinking about the future of our species coupled with serious investment is important. But Bezos and Musk (and most other investors) are missing the most significant — and smallest — technological opportunity to save humanity.

No one has captured this tech blindspot better than my friend and Ginkgo Bioworks Co-Founder Jason Kelly. He did it by showing an image like this:

“What’s the most advanced piece of technology you see on this desk?,” Kelly asked his audience. The correct answer is in green.

A $4 houseplant is one of the most astonishing objects ever assembled. It’s a biodegradable, carbon-capturing, self-replicating, solar-powered work of art. Have you ever bought an electronic gadget that even comes close?

The mind-bending fact that a common shrub is more advanced than the latest MacBook Pro is overlooked by almost everyone. We fail to see it for a simple reason: the coolest parts of a plant can’t be seen. Not with the naked eye, at least.

It’s at the molecular level that plants fix CO2, soak up sunlight and churn out nutrients that we can eat. Way down at the level of atoms and molecules, the most mundane living objects are doing things that our best engineers can only dream of.

Small solutions to big problems

Humanity faces enormous, imminent challenges. The way we use energy is poisoning the planet, we are on track to use up many of our most important non-renewable resources, and we are ill prepared for the next inevitable global pandemic. And that’s just a small sampling of the challenges we see coming; there are dozens more around corners we can’t see around.

Major advances in deep tech — the marriage of hard sciences and emerging technology — is going to be critical if humanity is to survive these challenges and thrive, but most of the money in the world is maintained or managed by people who do not have formal scientific training. For example, just 5% of the Forbes richest 400 people have formal scientific training. Most therefore invest in things they’re familiar with, like real estate, software and finance.

I founded OS Fund to support the scientists entrepreneurs bringing deep tech to market; leveraging hard sciences and technology to rewrite the basic operating systems of our world. Atoms, molecules, genes and proteins can be designed like never before. The biological world has already demonstrated what’s possible on this scale — if we’re going to aim big as a species, it’s time we think small.

At OS Fund, we don’t invest in particular problems. Instead of trying to solve energy or climate change or the spread of disease, we invest in the foundational technology that could be applied to solve all problems. In the same way that early computer companies like Intel, Apple and Microsoft helped spawn the modern era of computing, we aim to do the same thing with atoms, molecules, organisms and complex systems.

The scientists at Ginkgo Bioworks, one of the first companies in the OS Fund ecosystem, are charting their way by designing bacteria that puff out perfume, crops that fertilize themselves, gut microbes to make medicine, and much more. With three highly automated foundries up and running, the company is poised to upset almost every industry you can think of.

Arzeda, another OS Fund company, is using computers to design new genetically-encoded nanomachines, otherwise known as proteins. Although most of us know proteins only as food, these intricate biological objects actually do almost all the work needed to keep cells alive. Designing new proteins from scratch will let humanity play by biology’s rules, meaning we can design our way to better food, fuels and chemicals in the greenest way possible.

Another OS Fund company rewriting our world is NuMat, where they’re arranging atoms in MOFs (metal organic frameworks) to create the most powerful sponges you’ve never heard of. NuMat works at the intersection of high-performance computing, chemistry, and hardware systems to design and manufacture materials that can filter non-renewable material like xenon out of thin air.

But wait, I can hear you thinking, isn’t AI going to eliminate the need for this kind of innovation?

View story at Medium.com

View story at Medium.com

You Will Never Believe These Bizarre Truth Behind Food And Beverages

Further, out of these, nearly 20 million, one in 16 Americans, visit a full-service restaurant on any given day.

The food and beverages industry, a global one, is an interesting bag of surprising and often contradicting facts. The food and beverages industry is a really global one, meaning there is almost no place on this planet that this industry does not cover. You are as likely to find a food joint in Mongolia as you are in Mozambique. The reason is simple: we can live without many things, but not without food. Any surprise that this industry is a giant, valued at a few trillion dollars globally?

The food and beverages industry in the US is characterized by several interesting facts. Many of these could be in the positive and some, in the negative. Whether it is about the positive or the negative factors one is talking about, there is no doubt about one thing, which is that the food and beverages industry is one filled with very interesting facts. Let us take a look at some of these:

One in seven Americans eats fast food everyday

It is estimated that as many as 50 million Americans consume fast food every single day, without a weekend or a vacation! This is more than the population of many countries. The most important reason for this is the quickness and convenience associated with fast food. Further, out of these, nearly 20 million, one in 16 Americans, visit a full-service restaurant on any given day. Yet, surprisingly, this is the same percentage of Americans who have been eating outside for the past 15 years!

Millions of children eat fast food in the US

As many as a third of the children aged between two and nine years eat fast food daily in the US. The media could be playing a part in this because it is estimated that on average, the American child is exposed to three to five ads for fast foods every single day. This rate of consumption is cause for some worry for policy makers and health experts, although one silver lining could be that children are more aware of the importance of eating clean food.


American cuisine is still the top hit

Among the millions of Americans who make up the market for the food and beverage industry, four fifths of all food consumed in hotels in the US is American. While the cuisines of most other countries are still popular, this figure points to the overwhelming preference for American food by those who eat outside. Want to know which the least preferred cuisine is? It is Scandinavian and Nordic food, which is consumed by only two percent of those eating outside. Adding to the interesting facts about the food and beverages industry is the point that a high proportion of Americans like their food to contain local, fresh ingredients and flavors.

Americans eat the most outside during warm weather

Call it a case of sunny binge or the lethargy of getting out of home during the cold seasons; it is a fact that Americans eat more outside during the warm seasons.


The fast food industry is highly concentrated

While there are hundreds of players in the fast food industry, an interesting fact about the food and beverages industry is that almost all the food consumed by the Americans is sold by only a handful of companies such as PepsiCo, Kellogg and General Mills and a handful others.


Information about the food is an important factor

Another of the interesting facts about the food and beverages industry is that for Americans who eat outside, information about the food’s nutritional content is a major factor when it comes to eating outside. This is followed by how many options the restaurant offers for low calorie foods.

Want to recommend a restaurant to a friend? Think again!

Surprising as it may sound, one of the truly interesting facts about the food and beverages industry is that a friend’s recommendation or online suggestions are the least important factors that motivate people to go out and dine at restaurants. The top factors are still the quality of food, followed by the time taken to travel to the restaurant and the quality of service.

Move towards cleaner food

The move towards cleaner food by the industry as a whole is one of the other interesting facts about the food and beverages industry. With children themselves becoming aware of the need for cleaner food, as we just saw, does it surprise that chains such as McDonalds are making conscious efforts towards preparing and selling cleaner food?

Cleaner food

Nutritional labels can be deceptive

Facts about nutrition that are ubiquitous on food labels are misleading. They are almost never 100% truthful. While the facts relating to the percentage of the ingredients may not be fully wrong, the claimed benefits can be off target. Isn’t is one of the interesting facts about the food and beverages industry that in this information-driven society, there is still a lot of scope for manipulation?

Now, the most unpleasant interesting fact about the food and beverage industry…


America leads in food waste

Whether it is at homes or in restaurants, especially in the latter, the proportion of food that is wasted is extremely high. As much as two fifths of all the food eaten in restaurants ends up in the waste baskets. One of the main reasons for this factor is that what is left behind in the plates is insufficient to make a full meal of, as a result of which it finds its way to the bin. When the food wasted in transport and while being cooked is accounted for, this amounts to an average of $2,000 being spent on just wasting food by every American during a year.


This gives North America the dubious distinction of being the top waster of food anywhere in the world. This region wastes around 95-110 kilos of food per person per year, which places it several notches ahead of the region at the other end of the list: sub-Saharan Africa, which wastes around six to seven percent of this ratio. This wasted food can have extremely serious consequences for the rest of the world. While being responsible for a carbon footprint of about three gigatons, this wasted food also consumes as much as 28% of the world’s agricultural area!