QbD Development Process Evaluating Critical Steps

The selection of robust process parameters for Quality designs, and how to establish criteria to measure and discernable observances.

  • How to Build quality, safety, and efficacy into the manufacture of drug product
  • The ICH guidelines for pharmaceutical manufacturing
  • Risk-based, modern pharmaceutical manufacturing
  • Understanding Target Quality Profile, Critical Quality Attributes
  • Process parameters and design experiments
  • Regulatory concerns FDA and EMA on QbD

To establish a procedure for the proper assessment of product and process design, Also, to align evaluation of product quality standards for chemistry manufacturing and controls (CMC) review and to maintain quality standards per Office of Pharmaceutical Science (OPS)

It should be noted that OPS is responsible for assuring that the quality of drug products for the entire pharmaceutical industry follow uniform policy and review processes during drug product development (the manufacture and formulation).

Therefore, it is incumbent on all personnel involved with the preparation of documentation for subsequent submission to the regulatory authority recognize the importance of creating and maintaining a clear scientific and sound approach for all products.

  • Quality target product profile (QTPP) forms the basis for design and the development of the product. Considerations for the Quality Target Product Profile (ICH guideline Q8 R2)
  • Critical quality attributes (CQA) is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality
  • Process Analytical Technology (PAT) which is a Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance
  • Risk Assessment (RA)one can recognizing critical attributes that are going to affect final quality of product

Process Evaluating Critical Steps


6 Enticing Ways to Improve Your Software Verification Skills

Software verification and validation failure is the third most often cited violation for medical devices by the FDA.

Fremont, CA: Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing a webinar on January 22 on the topic of Software Verification & Validation. This 90-minute session is aimed at imparting six enticing ways to improve your software verification skills.

The speaker, Lena Cordie, who brings over 20 years of quality and project management experience, will show how organizations can vet their software verification skills to ensure that they meet the set regulatory standards, which is a prerequisite for gaining approval for their products and to also gain consumer confidence.

Please visit https://www.compliance4all.com/control/w_product/~product_id=502319LIVE to enroll for this session.


The primacy of software verification and validation in a medical device can never be understated. Software verification and validation is that crucial seal on the medical device that assures that the product performs its set functions satisfactorily while meeting the specifications set out for it.

The importance of having the software verified and validated can be understood from the fact that this is the essential requirement that certifies that the product performs satisfactorily. Failure to meet verification and validation standards results in a substandard product, the surest recipe for disaster which could be of any magnitude. Software verification and validation failure is the third most often cited violation for medical devices by the FDA.

But software in medical devices being of a complex nature, the result of a complex interplay of not only elements within the device, but also many connecting devices and the users. This being its nature, it has to be designed in such a fashion that all these are in perfect sync with each other. While this is the primary challenge of developing software for medical devices; ensuring that the product also simultaneously meets regulatory requirements, set out in Part 11, which are not lax by any stretch of imagination, is another.

The goal of this extremely valuable session is to help participants overcome the fears and anxieties concerning software verification and validation. The speaker, Lena Cordie, will help participants ease the pain of meeting regulatory standards for software verification and validation.

She will get down to explaining the FDA 11-element documentation model that is most preferred in various applications by the FDA. She will include ERP, in-device, as-device, process/equipment control and cGMP data/Part 11 applications in this discussion. Other areas into which she will delve include the use of FDA guidance’s, GAMP 4/5, 21 CFR 11, and other applicable industry software validation models, all of which are complemented with a learning of the ISO 14971/ICH Q9 Risk Management models and their real-world implementation.

The core of her teaching at this crucial webinar will be on offering understanding of six enticing ways to improve your software verification skills. These are:

  • Developing and creating buy-in for a project validation plan
  • Understanding what the FDA accepts as an appropriate documentation model
  • Beyond just in-product software V&V – understanding FDA’s expectation for your testing software, ERP software and more
  • When and how to use DQ, IQ, OQ, PQ or their equivalents
  • How GAMP 4/5 requirements fit into your V&V planning and execution
  • Detailing the FDA’s 11 key V&V documentation elements.

This webinar is of invaluable benefit to professionals in medical device industries who have to deal with some or another aspect of software verification and validation. These include Software Developers and Managers, Internal Auditors, Quality Assurance and Management Personnel, Software Quality Personnel, Software Test Personnel, Regulatory Affairs Management Personnel, IT Managers and System Administrators, and Software Validation Engineers.

Lena will cover the following areas at this webinar:

  • FDA Quality System Requirements for software
  • FDA guidelines on software verification and validation
  • Smart software verification methods
  • How to design smart validation tests
  • How to conduct black box testing and white box testing to perform thorough validation.


About the speaker:

Lena Cordie, who works as a consultant at Qualitas Professional Services, LLC, is a senior quality and project management specialist who has more than two decades in the medical device industry. During these years, she has gained expertise of overseeing all quality and regulatory functions, production, product procurement, and order fulfillment.

She has been helping companies implement quality management systems, UDI solutions for labelling and FDA GUDID submissions, and providing validation, documentation and project management resources to global medical device companies.

Read more at http://bit.ly/2soNVsY

This Article Will Make Your Environmental Compliance Amazing: Read or Miss Out!

Both EPA and OSHA have tons of information about every aspect of environmental compliance. They are handy and easy to understand.

Environmental compliance is a critical requirement for workplaces in many parts of the world. In the US, this aspect of compliance is undertaken by the Environmental Protection Agency (EPA) in conjunction with the Occupational Safety and Health Administration (OSHA). These agencies coordinate with each other to ensure that environmental hazards are kept within specified limits so that they don’t affect the workforce or cause damage to the environment beyond prescribed norms or levels.

An example of the way by which these two agencies coordinate is the one that relates to the control of accidental release of chemicals from designated workplaces that may have an adverse impact on employees, the environment or the general public. While OSHA is given the responsibility of ensuring that chemical releases do not affect workers in the workplace under Sec. 304; Sec. 112 (R) of the EPA’s Clean Air Act describes how to protect the general public from the effects of such hazards.

In areas such as chemical accident prevention, the EPA and OSHA work closely in a number of designated areas, which include:

  • Helping companies that come under their regulatory guidelines to ensure compliance
  • Guiding and interpreting the regulations
  • Coordinating in strategies and actions relating to enforcement and compliance
  • Putting in place and implementing mechanisms for sharing information.

The fact that two federal agencies work in tandem to ensure environmental compliance makes this a serious issue that companies can ignore only at their own peril. The understanding of facts such as this goes a long way in ensuring environmental compliance because it drives home the criticality of ensuring environmental compliance.

Simple, yet effective tips for ensuring environmental compliance

This article will make your environmental compliance amazing: it offers simple, down-to-earth tips on how to ensure environmental compliance rather than drilling down complex and incomprehensible insights. These are some of the steps you could take to ensure environmental compliance:

Be in touch with the government agencies

This is the most obvious, yet the most effective way of ensuring environmental compliance. It is the governmental agencies that are responsible for ensuring compliance. So, who could be a better guide to help you with yours? Directly interacting with agencies such as EPA and OSHA will help you take the proper steps right in consultation with them. Also, make ample and maximum use of the resources that are available all over the Net. Both EPA and OSHA have tons of information about every aspect of environmental compliance. They are handy and easy to understand.

Take expert help

Experts are what they are: very knowledgeable professionals in their field. Taking the help of an environmental compliance expert will help you stay clear of the provisions relating to environmental compliance. Selecting the appropriate one in this connected world should never be an issue.

Implement compliance software

Many software applications that not only guide you in compliance but also carry out most of the requirements are available in the market. This type of software application is very helpful in taking the pain and the guesswork out of environmental compliance implementation. Agreed, the cost of buying, installing and running these software applications can be expensive. Yet, this cost neutralizes over the long run. More importantly, this cost is very small in relation to the cost of noncompliance.

Train your employees

No understanding of the regulations or implementation of any other tip is of any value unless the employees become an active part and stakeholders in ensuring compliance with the environmental regulations. Employees are the central players in environmental compliance. It is primarily for them that all the regulations are made. These are the core stakeholders in ensuring environmental compliance. The key is to make understand the benefits they get by implementing and complying with the environmental guidelines. This is when they can become active players in the entire endeavor.

Why You Need to know about FAA Compliance (Federal Aviation Administration)

Develops and implements programs that are aimed at controlling noise from aircraft and monitors other environmental factors that affect civil aviation.

We have heard about the very high standards being set by the airline industry around the world, especially so in advanced economies such as the US. Much of this is owed to the efforts and purpose of the Federal Aviation Administration. The FAA is an agency that comes under the United States Department of Transportation. Its primary aim, as indicated by its name, is to regulate and oversee civil aviation within the US. It is also responsible for operating and developing the National Airspace System.

The FAA has taken upon itself its mission of ensuring safety in civil aviation. In the process of doing this, the FAA has its set of responsibilities. The FAA:

– Regulates civil aviation with the aim of ensuring aviation safety within the US and away

– Researches and develops the National Airspace System and civil aeronautics

– Regulates commercial transportation in the US

– Puts in place a system of civil and military aircraft air traffic control and navigation and operates it

– Is involved in promoting and developing civil aeronautics, innovative aviation technology being among them

– Grants licenses for commercial space launch facilities, as well as private launches of space payloads carried on expendable launch vehicles

– Develops and implements programs that are aimed at controlling noise from aircraft and monitors other environmental factors that affect civil aviation.

Here’s why you need to know about FAA

Here’s why you need to know about FAA: The Federal Aviation Administration is a powerful and all-encompassing agency when it comes to ensuring civil aviation safety. Its activities cover all aspects of civil aviation safety and administration. The broad areas in which the FAA regulates activities aimed at ensuring these include:

– Regulation of all aspects of aviation safety

– Transportation in the commercial space

– Management of airspace and air traffic

– Civil aviation overseas

– Core areas relating to civil aviation, such as research, engineering, and development

– Handling and overseeing all air navigation facilities

The FAA’s role in air traffic management is another of the reasons why you need to know about FAA

Indeed, there is another core reason for which you why you need to know about FAA: in addition to all these, the FAA is involved in a very big way with air traffic management. These are some of the ways in which the Federal Aviation Administration is involved in air traffic management:

Firstly, most of the tower-based ATM that you get to see at all major airport facilities, are provided by the FAA.

Also, the FAA is only agency authorized to provide enroute ATM services all over the US. This task of the FAA is the responsibility of the Air Traffic Organization (ATO), which is an administrative entity that is related to, but separate from the FAA’s organizational structure.

Finally, wondering who is responsible for safety regulation of all aviation activities within the US, including that of ATM? It is the FAA. The FAA has established an ATM Safety Oversight organization within its regulatory division and is responsible for the oversight of safety concerning the ATO’s operations and activities.

How to Teach IT Security Better Than Anyone Else

Keep passwords top secret and don’t share them with anyone other than close family members. It is best to avoid sharing them with even their best friends.

IT security is a core topic for an IT professional. IT security is a specialization that is highly sought-after for a variety of reasons. These are some of the reasons for which IT security is a profession many people like to get into:

  • The world over, organizations are realizing that IT security is of paramount importance because the threat of hacking is very real
  • IT security is the surest insurance against cyberattacks, which, when they happen place, can be devastating for organizations in terms of both financial and reputational costs
  • IT security ensures that organizations keep their reputation intact. An organization that cannot take care of its own IT security does not enjoy a good name
  • The need for how to teach IT security better than anyone else is best understood in the light of the fact that cyber incidents have been growing phenomenally year upon year. It is estimated that nearly a quarter of a million new malware samples are launched into cyberspace every single day. The number of attacks was just 4,000 a day in only the first half of 2016, during which there were some 320,000 ransomware infections on the Net.

These statistics perhaps best illustrate the need for understanding how to teach IT security better than anyone else. An organization that learns how to teach IT security better than anyone else saves itself all the negativities associated with a cyberattack.

Learning starts early

How to teach IT security better than anyone else should be ingrained very early. Organizations need not have to wait till they face cyberattacks to start learning how to deal with IT security. In fact, parents and teachers have a responsibility to teach about IT security to children from a very young age. This is because home systems which many children play with are highly vulnerable to cyberattacks. Since children will be handling these systems, the vulnerability is stronger because children are easy prey to cyberattacks. A harmless looking attachment or file can open a Pandora’s Box.

IT Security

So, how to teach IT security better than anyone else begins at home. Cyber incidents need to become part of children’s curricula, just the way they need to be educated about unhealthy habits and other unpleasant aspects of upbringing. For parents that are concerned about how to teach IT security better than anyone else, a good beginning would be set the right security systems on their home systems:

  • Avoid using names in passwords
  • Install apps only with the knowledge and permission of the elders
  • Never, ever upload pictures without telling the family about it
  • Make sure they add only known people on their networks.
  • Keep passwords top secret and don’t share them with anyone other than close family members. It is best to avoid sharing them with even their best friends.

Now, educating elders is as important

While children need to become well educated and trained about the use of computer systems, elderly people are at the other end of the spectrum. Elderly people, who had no clue about computer systems when they were growing up or during their careers, are equally vulnerable to exposing themselves to cyberattacks. Many people in the elderly age group are genuinely unaware of the gravity of these attacks. The same tips that have been mentioned for kids hold good for elders, as well. In addition, aged people need to understand the following:

  • The need to install antivirus software
  • Detecting a security certificate
  • Know how risky it is to open mails from suspicious senders. It is not uncommon to find many elderly people, even educated ones, being duped of their earnings because they respond to quick money-making solicitations from unknown senders who ask them money for transferring amounts. Incredible as it may sound, it is a fact that has left even the police baffled in many cases
  • They need to be educated about how to handle antivirus alerts from systems.

Everyone needs to understand how to teach IT security better than anyone else

Learning on how to teach IT security better than anyone else should be inculcated early and into every group. While the two endpoints have just been elucidated, it is also important to understand that IT security is a must for everyone. Some of the generalized tips that organizations, educational institutions and everyone who uses IT systems can follow include:

  • Make passwords as strong as you can
  • Install trustworthy antivirus software for your systems
  • Never click on mails that ask you to click on links
  • Keep your browser security systems up-to-date and allow them to use software that block harmful entries
  • Delete spam mails regularly

Be prudent about opening mails that are from fishy sources.

Pump Up Your Sales with Some Remarkable Lean Management Tactics

Spending a few productive minutes with HR is likely to save you valuable time on three or four unproductive interviews running into hours.

Lean management for sales? Isn’t that kind of oxymoronic? We have been told all along that lean management is ideal for areas such as manufacturing, services, operations and supply chain since it is essentially built upon minimalization of waste. How does sales fit into this picture?

Fact is, it does. You can pump up your sales with some remarkable lean management tactics. As we know, lean management is a set of practices that helps an organization to optimize its revenues while keeping its resources at a minimum by avoiding wastage at every possible point. Lean management is primarily about creating value by identifying the core points at which wastage occurs and plugging them in every viable way.

Lean management consists of streamlining and harmonizing the points of productivity across the areas of service, technology, manufacturing and many others. Now, this understanding is necessary to derive a grasp of how you can pump up your sales with these remarkable lean management tactics. So, what is in all this for sales is a question some people might ask, in just the way many others have. They ask, with quite some justification, if lean management can work in an area that offers sales incentives to its staff to reward and motivate them.

How does lean management work for sales?

Let us try to understand how lean management concepts go for sales:

The starting point, in fact the real point, to how to pump up your sales with some remarkable lean management tactics is to realize that inculcating activities in which waste does not occur is not restricted to areas with which lean has come to be identified. Simple: you can adapt lean principles into all the areas of sales starting from interviewing candidates for the job.

Let me explain: when you shortlist candidates for interviewing to be brought into the sales team, whether you realize it or not, the organization spends a lot of unnecessary resources on arranging the interview. These could range from calling up the candidate, spending time on the interview and deciding about her suitability. What if the candidate is rejected? Haven’t you wasted a lot in terms of resources? Haven’t you wasted your manager’s time, the expense on phoning or any other such items?

Adapt the same lean thinking for sales as well

Pumping up your sales with some remarkable lean management tactics consists of looking at all these as wasteful activities. Well, you may be wondering if I am saying that interviewing candidates is a wasteful activity. It certainly isn’t. But spending a lot of time and money on interviewing the wrong candidate certainly is!

If you keep the lean principles in mind, you would ask HR to shortlist a more suitable candidate, where the chances of rejecting are fewer, and you could be doing with a lot less waste of your time. Spending a few productive minutes with HR is likely to save you valuable time on three or four unproductive interviews running into hours.

And what about lean practices during the sales itself? Setting up the right time for the sales appointment, avoiding travel on a call that is not likely to result in a deal, avoiding expensive trips…there are umpteen ways by which you can pump up your sales with some remarkable lean management tactics.

Lean management in creating value for the customer

And, there is another very core aspect of lean management for sales, which will help you pump up your sales with some remarkable lean management tactics. Creating value for the customer is what a business essentially exists for, right? When this is done by applying lean management principles, there is a tremendous boost to the value the customer gets from the company’s products or service. One way of accomplishing this is by integrating sales with the entire processes the company has.

Integrating sales with the other processes ensures that sales becomes part of the operations to the extent that operations are designed and implemented keeping sales in mind and not in isolation of it. Bringing this vital element into the processes rounds up the whole cycle and enhances the value chain on an unimaginable scale.

The direct offshoot of such an integration is that when the customer sees value in the company’s products or services, there are fewer complaints or recalls. This is the finest means of augmenting the company’s resources because the fewer these items, the more it can leverage its resources for further improvement.

In this way, many such activities round sales can be minimized. These count for lean practices, although it must be said that these lean principles have not been designed keeping sales in mind. That however, does not take away from the relevance or value of lean principles to sales.





4 Important CLSI Guidelines According to Assay Validation

They will use real life examples to demonstrate how to overcome some of the practical challenges when guidelines can not be exactly follow.

Each of the assay performance characteristics (specificity, sensitivity, accuracy, precision, linearity, stability, reportable range, reference range) will be explained in terms of experimental design and statistical analysis.

Most assay validations are a compromise between scientific principles, regulatory requirements, and limited resources in reality. They will use real life examples to demonstrate how to overcome some of the practical challenges when guidelines can not be exactly follow.

Though the CLSI guidelines provide much more actionable details than other guidelines (e.g. by FDA, USP), the understanding and adoption of the guidelines remains a challenge for the broad users. Plus, due to reality restraints, oftentimes the study design and/or the statistical analysis suggested by the guideline cannot be exactly followed.

In this webinar, major CLSI EP guidelines will be introduced. The focuses are

(1) interpreting the procedure for each guideline,

(2) intuitive explanation of the statistical methodologies,

(3) using real-life examples to illustrate the use of the guidelines, and

(4) discussing some solutions when facing challenges in implementing the guidelines.


These are the areas covered by the mentor


  • Sensitivity (EP17)
  • Accuracy (EP9)
  • Precision (EP5)
  • Specificity (EP7)
  • Matrix effect (EP14)
  • Statistical Process Control (SPC)

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