Testing GxP system that is FDA-compliant

Testing GxP system that is FDA-compliant

Process validation is the method of using data from stages ranging from the process design stage to production, to ensure that the process that is being used can deliver consistently high-quality products. Companies that come under the life sciences must comply with GxP regulations to ensure that their processes meet the regulatory guidelines to be GxP compliant. Computer Systems Validation is the method of ensuring that all computer systems used that go into the production of products in the life sciences industry comply with set regulations and meet the specifications relating to quality.

For the FDA, CSV is more than just hardware and software. It also includes any instruments that are linked to the computer system or are part of it, as well as staff that operate the computer system under set SOPs. The FDA considers GxP as being much broader, as it includes static and dynamic testing.

Testing GxP system that is FDA-compliant5

Testing and verifying of computerized systems is a crucial aspect of GxP systems. It is a means for showing that a computer system meets the intended requirements. Carrying out testing properly and appropriately is a major regulatory expectation, whose scope and nature have been defined by many regulations from the FDA, the EU’s GMP Annex 11 and other documents.

So, any regulated company has to demonstrate compliance with GxP regulations and show how fit these products are for their intended use. The criterion for the effectiveness of testing is its ability to show compliance with regulatory requirements. This is a means to ensuring the following:

  • Patient safety
  • Product quality
  • Data integrity as a result of controlling identified risks.

The guarantee that systems perform as intended for their use shortens the overall lifecycle of implementing and operating the system. It also prevents delays to the use of the system that could have happened because of the time taken to make corrections to the system.

Testing GxP system that is FDA-compliant1

At the other end, not carrying out testing adequately or appropriately could result in issues that could surface later on in the lifecycle. Detecting and fixing them at that point is very expensive, cumbersome and very time consuming. Not only do such systems fail to meet intended requirements; they also incur exorbitant costs into corrections, maintenance and support.

Not only these; not adequately and appropriately carrying out test functions adversely impacts in any or all of these:

  • Patient safety
  • Product quality
  • Data integrity
  • Regulatory compliance requirements
  • Ability to meet intended use of the system.
  • Stringent actions from the regulatory agencies, which could include citations and other penalties
  • The business bottom line and the company’s credibility.

A thorough guidance session

Testing GxP system that is FDA-compliant3

As can be seen from all these; testing of the GxP systems is an area in which no company can afford to be lax. The means of doing this in the right manner that meets the regulatory expectations and help avoid all of the undesirable effects listed above will be taught at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance.

Angela Bazigos, a seasoned executive with 40 years of experience in the life sciences & healthcare industries, who is CEO, Touchstone Technologies Silicon Valley, will be the Director at this seminar. Please log on to Testing GxP system that is FDA-compliant to enroll for this seminar and gain from the experience that Angela brings into life sciences. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

All areas and aspects of GxP testing

The various GxP testing methods and their varieties should be based on risk, complexity and novelty of the software. The aim is to confirm that system specifications have been met. The company may have to carry out multiple stages of review and testing depending on the type of system, the development method applied and the use of computerized system. The testing being of such a complex nature; companies should have the ability to justify the method chosen and the sufficiency of their testing approach.

The use of a scientific Quality Management System such as ICH Q9 to determine the appropriate level of verification and documentation goes a long way in making the testing process effective.  Demonstrating that all required risk controls are in place is one of the purposes of designing tests. Whenever changes are proposed to the system, they should be followed by an impact analysis to determine the extent of any reverification, including any regression testing required. These changes to the system should be made only in accordance with a predefined change control procedure, which should include provision for proposing, approving and/or backing out of the change.

Angela will explain all these in detail at this session. In the process of this explanation, she will cover the following areas:

  • How does testing fit into GaMP5 lifecycle?
  • Risk based methodology for testing
  • How do I leverage supplier testing?
  • What should I test?
  • How much testing is enough?
  • How should I conduct the tests?
  • How should I document my testing?
  • How do I maintain the testing integrity of my system?
  • Testing related 483s and Warning Letters
  • Case Studies.

 

keep continue to FDA compliant

 

 

 

 

GMP and Regulatory Expectations for Early IND Products

 GMP and Regulatory Expectations for Early IND ProductsWhat the FDA’s recent guidance documents covering GMP requirements for Phase I products have done is to significantly reduce a few of the complexities that early phase products are typically against. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I.

These new guidelines appear to remove the need to follow GMPs for Phase I products; yet, this need persists in the Food, Drug, and Cosmetic Act. So, what can be said is that the need for GMP requirements for Phase I products has only been altered, not done away with. The nature of the investigational drug and the extent of the study that is planned will now determine the nature and extent of GMP-related activities.

A training session that will give complete understanding of these aspects

Steven S. Kuwahara, Founder and Principal, GXP BioTechnology LLC, will offer complete clarity on all these points of GMP and regulatory expectations for early IND products at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. Please visit GMP and Regulatory Expectations for Early IND Products to enroll for this seminar.

This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Advice on the GMP guidance document

GMP and Regulatory Expectations for Early IND Products3

At this seminar, Dr. Kuwahara will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. It will be a one-source course at which the regulations and guidelines that apply to early phase products will be presented. In a few cases, these may not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. Dr. Kuwahara will present these items in the order of product development starting from the point of R & D activities and culminating in the completion of Phase 2 clinical trials.

GMP and Regulatory Expectations for Early IND Products1

Any pharmaceutical personnel who must deal with products both in early and later phases of development, will find this presentation highly valuable, as it will make them aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have altered the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time, some of the things that may appear to have changed, have not, and personnel in the pharmaceutical sector should be aware of this. This is the learning that Steven will emphasize at this seminar. Directors, Managers and Supervisors in Regulatory Affairs, Quality Assurance and Quality Control will get a grasp of these aspects.

Over these two days, Dr. Kuwahara will cover the following areas:

  • Very Early Stages
  • GLP requirements
  • Early Pre-IND Studies
  • Meetings and Preparing for the IND
  • GMPs for Phase 1 IND products
  • Requirements for Phase 2 INDs
  • Preparing for IND Meetings.

 

To continue GMP updates

Video of father comforting newborn son receiving his first vaccines goes viral

Video of father comforting.jpg

On October 26, first-time father Antwon Lee took his two-month-old son Debias King to get his first vaccinations. Lee, 29, said he was very nervous for the appointment, telling People Magazine that he “felt kind of scared a little bit,” as he knew the child was “going to go through some pain.” Before the visit, he also continually reassured his son that he could cry if he needed to.

TEARS AS CONJOINED TWINS DIE DAY AFTER BIRTH

When it came time for the vaccinations, Lee held his son in his arms and told the little boy to “stay strong,” while Shamekia Harris, Lee’s girlfriend, recorded the visit on her phone. Little Debias did cry as the nurse gave him his shots, but stopped soon afterward when Lee consoled him.

The video has since gone viral, with about 13 million views, 51 thousand likes, and 186 thousand shares as of Wednesday.

Sadly, Lee’s father, Anthony Lee, 57, died that same day due to complications from drinking. Lee explained to People that he was emotional and very close to his father, and that he later spoke to his son Debias about his hopes for the future.

“I talked to him like a grown up … I told him, before I leave, want to see him succeed,” Lee said.

Lee wishes that the video will remind others of the importance of fatherhood, “I want them to take care of their kids, because when you sign up for something, you have to stick with it,” he told People.

FOLLOW US ON FACEBOOK FOR MORE FOX LIFESTYLE NEWS

Lee, however, isn’t the only person to go viral for his vaccination video: In 2014, pediatrician Michael Darden gained attention for his unique approach to giving shots, and the video still doesn’t disappoint:

Read More: http://snip.ly/9obne#http://www.foxnews.com/health/2017/11/01/video-father-comforting-newborn-son-receiving-his-first-vaccines-goes-viral.html

The science of Sad: understanding the causes of ‘winter depression’

The science of Sad

For many of us in the UK, the annual ritual of putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues as autumn well and truly beds in. This might be felt as a lack of energy, reduced enjoyment in activities and a need for more sleep than normal. But for around 6% of the UK population and between 2-8% of people in other higher latitude countries such as Canada, Denmark and Sweden, these symptoms are so severe that these people are unable to work or function normally. They suffer from a particular form of major depression, triggered by changes in the seasons, called seasonal affective disorder or Sad.

In addition to depressive episodes, Sad is characterised by various symptoms including chronic oversleeping and extreme carbohydrate cravings that lead to weight gain. As this is the opposite to major depressive disorder where patients suffer from disrupted sleep and loss of appetite, Sad has sometimes been mistakenly thought of as a “lighter” version of depression, but in reality it is simply a different version of the same illness. “People who truly have Sad are just as ill as people with major depressive disorder,” says Brenda McMahon, a psychiatry researcher at the University of Copenhagen. “They will have non-seasonal depressive episodes, but the seasonal trigger is the most common. However it’s important to remember that this condition is a spectrum and there are a lot more people who have what we call sub-syndromal Sad.”

Around 10-15% of the population has sub-syndromal Sad. These individuals struggle through autumn and winter and suffer from many of the same symptoms but they do not have clinical depression. And in the northern hemisphere, as many as one in three of us may suffer from “winter blues” where we feel flat or disinterested in things and regularly fatigued.

Putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues.

One theory for why this condition exists is related to evolution. Around 80% of Sad sufferers are women, particularly those in early adulthood. In older women, the prevalence of Sad goes down and some researchers believe that this pattern is linked to the behavioural cycles of our ancient ancestors. “Because it affects such a large proportion of the population in a mild to moderate form, a lot of people in the field do feel that Sad is a remnant from our past, relating to energy conservation,” says Robert Levitan, a professor at the University of Toronto. “Ten thousand years ago, during the ice age, this biological tendency to slow down during the wintertime was useful, especially for women of reproductive age because pregnancy is very energy-intensive. But now we have a 24-hour society, we’re expected to be active all the time and it’s a nuisance. However, as to why a small proportion of people experience it so severely that it’s completely disabling, we don’t know.”

There are a variety of biological systems thought to be involved, including some of the major neurotransmitter systems in the brain that are associated with motivation, energy and the organisation of our 24-hour circadian rhythms. “We know that dopamine and norepinephrine play critical roles in terms of how we wake up in the morning and how we energise the brain,” Levitan says. One particular hormone, melatonin, which controls our sleep and wake cycles, is thought to be “phase delayed” in people with severe Sad, meaning it is secreted at the wrong times of the day.

Another system of particular interest relates to serotonin, a neurotransmitter that regulates anxiety, happiness and mood. Increasing evidence from various imaging and rodent studies suggests that the serotonin system may be directly modulated by light. Natural sunlight comes in a variety of wavelengths, and it is particularly rich in light at the blue end of the spectrum. When cells in the retina, at the back of our eye, are hit by this blue light, they transmit a signal to a little hub in the brain called the suprachiasmatic nucleus that integrates different sensory inputs, controls our circadian rhythms, and is connected to another hub called the raphe nuclei in the brain stem, which is the origin of all serotonin neurons throughout the brain. When there is less light in the wintertime, this network is not activated enough. In especially susceptible individuals, levels of serotonin in the brain are reduced to such an extent that it increases the likelihood of a depressive episode.

The most popular treatments for Sad is bright-light therapy.

Read More: http://snip.ly/25gi4#https://www.theguardian.com/lifeandstyle/2017/oct/30/sad-winter-depression-seasonal-affective-disorder

Click here To join us for more information, get in touch

The use of Applied Statistics for FDA Process Validation

Why you Should be Worried about HIPAAThe use of Applied Statistics for FDA Process Validation is considered a matter of very high importance in the pharmaceutical industry. The FDA’s guidance for the industry, which it called “Process Validation: General Principles and Practices”, was set up in 2011. This guideline sets the framework for Process Validation in the pharmaceutical industry. The FDA prescribes a three-stage process that any organization in the pharmaceutical industry has to set up:

  1. Process Design
  2. Process Qualification
  • Continued Process Verification.

The Process Design stage, which is called Stage 1, is when the organization defines the commercial manufacturing process. The knowledge that the organization has gained through development and scale-up activities serves as the basis for the development of this definition.

The Process Qualification, or Stage 2, involves evaluating the process design for the purpose of determining if the process defined in Stage I has the capability for reproducible commercial manufacturing.

The next stage of the FDA process validation stage is to determine if the Process Design stage and the Process Qualification stage give the ongoing assurance that the process remains in a state of control during routine production. This is what Stage 3, the Continued Process Verification, does.

Thorough understanding of how to implement Applied Statistics for FDA Process Validation

GMPs for Combination Products and 505(b)(2) Products

The ways of using Applied Statistics for FDA Process Validation will be the topic of a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be organizing. At this seminar, Richard Burdick, Emeritus Professor of Statistics, Arizona State University (ASU) and former Quality Engineering Director for Amgen, Inc., will be the Director.

Please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901132SEMINAR?wordpress-SEO to register for this meaningful and highly valuable seminar on applied statistics for process validation. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A methodical approach to implementing statistical methodologies

Top 20 Costly Mistakes

The focus of this two-day course on Applied Statistics for FDA Process Validation is the various ways by which a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance can be established.

Dr. Burdick will begin with a primer on statistics, where he will explain how the methods of Applied Statistics for FDA Process Validation seminar can be applied in each remaining chapter.

The two fundamental requirements for Process Validation, namely the application of statistics for setting specifications and assessing measurement systems (assays), will be taken up next.

The next aspect of applied statistics Dr. Burdick will move on to is how to apply statistics through the three stages of process validation as defined by requirements in the process validation regulatory guidance documents.

Since the methods taught through all these three stages are recommended by regulatory guidance documents; this seminar on Applied Statistics for FDA Process Validation will provide references to the specific citations in the guidance documents.

The aim of this learning on Applied Statistics for FDA Process Validation is to lead participants into ways of establishing a systematic approach to implementing statistical methodologies into a process development and validation program that is consistent with the FDA guidance.

Complete learning on Applied Statistics for FDA Process Validation

DBq4j0UXsAAvaiX

Over the two days of this seminar, the participants will learn how to:

  • Apply statistics for setting specifications
  • Assess measurement systems (assays)
  • Use Design of Experiments (DOE)
  • Develop a control plan as part of a risk management strategy, and
  • Ensure process control/capability.

All concepts at this Applied Statistics for FDA Process Validation seminar are taught within the three-stage product cycle framework defined by requirements in the process validation regulatory guidance documents.

Although aimed at the pharmaceutical industry, this seminar on Applied Statistics for FDA Process Validation provides a useful framework for other related industries, as well.

In this important learning on Applied Statistics for FDA Process Validation; Dr. Burdick will cover the following areas:

  • Apply statistics to set specifications and validate measurement systems (assays)
  • Develop appropriate sample plans based on confidence and power
  • Implement suitable statistical methods into a process validation program for each of the three stages
  • Stage 1, Process Design: utilize risk management tools to identify and prioritize potential critical process parameters; and define critical process parameters and operating spaces for the commercial manufacturing process using design of experiments (DOE)
  • Stage 2, Process Qualification: assess scale effects while incorporating large (pilot and/or commercial) scale data; develop process performance qualification (PPQ) acceptance criteria by characterizing intra and inter-batch variability using process design data and batch homogeneity studies; and develop an appropriate sampling plan for PPQ
  • Stage 3, Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable.

keep enhancing FDA Process Validation

Professionals Involved in The FDA’s Tougher Import Rules for 2017

Tougher Import Rules for FDA Imports in 2017

Of late, the FDA and the Customs and Border Patrol Service (CBP) have become increasingly agile, smart, sophisticated and demanding when it comes to the submission of information and adherence to government procedures from importing firms. The FDA and the CBP can delay, detain or refuse shipments of firms do not properly execute an import and export program.

The CBP’s new Automated Commercial Environment (ACE) computer program has carried out several changes to the process of import logistics and information reporting for FDA regulated products. The alternatives to noncompliance with the requirements of the ACE program: A shipment may be stopped before it is even loaded at the foreign port. Ships that refuse to or fail to use the ACE program also carry a fine of up to $10,000 for every offense.

Or, when the FDA detains a company’s product; it will begin an expensive and time-consuming legal process. Since the agency expects companies to have the import coding information accurate and up-to-date; companies that do not have a clear understanding of the automated and human review process can expect to have their shipments detained.

One more area that poses a challenge for importers is when the FDA decides that they should bring the products back to the port of entry after they received a release but cannot locate the product that has been sold. In such a scenario, companies that go through this process attract a fine that is three times the value of the shipment. This is in addition to the other adverse legal concerns and strategies that are attached to this action. Overall, the costs of not complying with the FDA’s guidelines on imports can be very high and can carry very expensive consequences for importing companies.

There are positives, too

The FDA_s Tougher Import Rules for 20171

However, not all is lost. The FDA is implementing the Voluntary Qualification Importer Program under the FDA Food Safety and Modernization Act. Aimed at incentivizing importers who instill a high degree of confidence about the quality of food they import; the nub of this plan is that it establishes an FDA-supervised, fee-based program that expedites the review and importation of foods from importers who can show a heightened level of control over the safety and supply chain aspects of the imported food items.

Another convenience that the FDA offers is export certificates. Obtainable for a modest fee; these certificates may give an importer a competitive advantage in foreign markets. An FDA export certificate is actually a requirement by a few foreign governments.

Full learning on the FDA’s new import rules for 2017

The FDA_s Tougher Import Rules for 20173

All the aspects of the new FDA import rules will be taught at a highly absorbing two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing.

Casper Uldriks, an ex-FDA Expert and former Associate Center Director of CDRH, Olsson, who has served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health, where he developed enforcement actions and participated in the implementation of new statutory requirements for FDA; will be the speaker. to enroll for this course, please visit Professionals Involved in The FDA’s Tougher Import Rules for 2017. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Casper will impart learning on all these topics and on the ways by which to avoid these and related common problems that can become terribly expensive when a proper strategy and plan for dealing with them are not implemented. Importers need to put in place an established and effective business planning, whose ways will be shown at this seminar. A bonus of this course is that the speaker will also include tips on how to understand FDA’s thinking and offer anecdotal examples of FDA’s import program idiosyncrasies. He will also explain how to deal with common problems, such as returns for repair, importing QC samples, and investigational products.

Are you ready to join us to Keep Growing Up

 

 

 

 

A step towards better health care

 

step towardsToday, we live in an era of customization. Increasingly, customers can modify a product’s appearance, features, or content according to their unique needs or desires. Often, even the news we see in our newsfeeds is customized based off our preferences.

Why, then, are so many aspects of the health care industry still one-size-fits-all?

As doctors, we’ve seen firsthand how this can negatively impact patients who require more individualized care. One particular example is a practice known as “step therapy” or “fail first.”

Now, when patients visit their doctors for a prescription, the treatments they are prescribed are typically based on a variety of personal factors. These factors include their health history, underlying symptoms, and their doctor’s long-term understanding of their condition, such as whether they have already tried certain drugs under a different health insurance plan, if they have other medical conditions that might interfere with the drug’s effect, whether certain drug’s side effects will affect the patient’s ability to perform their job, or if the patient would prefer a drug that has a different ingestion method or dosage form. Treatment plans need to be based on the individual’s needs, and their doctors’ medical expertise and first-hand knowledge of their patients’ overall health.

 However, far too often, what happens next is the problem. When a patient goes to the pharmacy to fill their prescription, they may be informed that their physician-prescribed medicine will not be covered unless the patient first proves that another medication-one of the insurer’s choosing, not their doctor-will not work for them.

In such a case as this, failure is not only an option, it is the only option before getting appropriate treatment.

Under the current system, patients are left with a limited set of options: either try a medication that is not what their doctor recommended for their condition, or pay out of pocket for the treatment they need. For many people, that’s not a choice at all. They are simply forced to fail on a medication other than what their doctor prescribed.

Read More: http://snip.ly/3h8ax#http://thehill.com/blogs/congress-blog/healthcare/356083-a-step-towards-better-health-care