Seminar on “Applied Statistics for FDA Process Validation” by GlobalCompliancePanel

The FDA in 2011 provided a guidance titled “Process Validation: General Principles and Practices” for Process Validation in the pharmaceutical industry, during which it established a framework for the same. This framework consists of a three-stage process:

1) Process Design

2) Process Qualification, and

3) Continued Process Verification.

So, what is Process Validation? It is described in Guidance for Industry Process Validation: General Principle and Practices as “…the collection and evaluation of data, from the process design stage through commercial production…” into which the three stages described above are delineated in this Guidance:

Stage 1: Process Design: This is the stage in which commercial manufacturing process is defined, based on knowledge gained through development and scale-up activities

Stage 2: Process Qualification: The stage in which the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

Stage 3: Continued Process Verification: Gives the ongoing assurance during routine production that the process remains in a state of control.

While this much is for theory, how do organizations understand the ways to implement these practically? These will be explained in detail at a two-day seminar that is being organized on November 5 and 6 by GlobalCompliancePanel, a leading provider of professional training for the areas of regulatory compliance.

Being organized in Philadelphia, PA, this in person, live seminar will feature the Co-founder and Principal, Adsurgo, Heath Rushing, as the Director. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. Please register for this valuable learning session by visiting https://www.globalcompliancepanel.com/seminar/applied-statistics-for-FDA-process-validation-901969SEMINAR

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The aim of this course is to help its participants understand how to establish a systematic approach for implementing statistical methodologies into a Process Validation program that is consistent with the FDA guidance. The Director will begin with a primer on statistics, at which he will focus on the methods that will be applied in each remaining chapter.

He will then move on to giving an understanding of how to apply statistics for setting specifications and assessing measurement systems (assays), which are considered the two foundational requirements for Process Validation.

In the third and final step, the Director will show how to apply statistics through the three stages of process validation defined by requirements in the Process Validation regulatory guidance documents.

He will take up methods recommended by regulatory guidance documents through all these three stages and provide references to the specific citations in the guidance documents.

Heath will explain how to apply statistics for a range of functions. These include how to:

• Set specifications
• Assess measurement systems (assays)
• Use Design of Experiments (DOE)
• Develop a control plan as part of a risk management strategy
• Ensure process control/capability.

Although established for the pharmaceutical industry, it is a useful framework for other industries. Analyses in this course use the point-and-click interface of JMP software by SAS.

At this seminar, the Director 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.

Pharmaceutical and biopharmaceutical professionals who are involved with product and/or process design, validation, or manufacturing/control, such as Process Scientist/Engineer, Design Engineer, Product Development Engineer, Regulatory/Compliance Professional, Design Controls Engineer, Six Sigma Green Belt, Six Sigma Black Belt, and Continuous Improvement Manager will benefit from this seminar.

2 Day Seminar on “Death by CAPA – Does your CAPA Program need a CAPA?” – GlobalCompliancePanel

If there is a really solid edifice on which a strong Quality Management System (QMS) rests, it has to be Corrective and Preventive Action (CAPA). This is because a QMS can never guarantee safe and effective products without CAPA. An ineffective CAPA process leads to disastrous consequences like complaints, recalls, 483s, and warning letters.

An inefficiently conceived and implemented CAPA system means time and resources going down the drain. The criticality that CAPA has to a QMS can be gauged from the fact that it is one of the primary reasons for which the FDA issues 483’s and Warning Letters.

All these point to the need for the establishment of a solid CAPA process that is built into the QMS. An organization should ensure that it establishes a compliant, effective, and efficient process. Yet, despite the all-powerful importance that CAPA has for the medical device industry, many manufacturers in this area have difficulties in establishing and maintaining an effective CAPA process.

How do organizations overcome this problem? A two-day seminar, entitled “Death by CAPA – Does your CAPA Program need a CAPA?” from GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, will provide the answers. At this in person, live seminar, which is being organized in Philadelphia, PA on October 24 and 25, Susanne Manz, Quality and Compliance Expert/Auditor for Medical Devices, Manz Consulting, Inc., will be the Director.

Please join us for this highly valuable session by enrolling at This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

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The learning offered at this seminar will help participants establish an efficient and effective CAPA process that leads to an improvement in quality and compliance. Participants will learn the ways of streamlining and monitoring their processes that will ensure compliance and improved performance.

Susanne will explain the regulatory requirements regarding CAPA in detail. She will sort out the various myths surrounding CAPA, as well as the challenges of managing CAPAs. This knowledge will help them prevent and overcome common problems and pitfalls. She will offer an explanation of some of the best practices in establishing a CAPA, the knowledge of which helps organizations insulate themselves against an FDA inspection.

Over the two days of this seminar, participants will hear detailed lectures on all the elements of a CAPA program. Susanne will explain the ways in which these elements connect to other parts of the organization’s Quality Management System. The Director will explain to participants ways by which they can create a CAPA program that results in:

• Improvement in product quality
• Reduction in compliance issues
• Advancement in their business success.

An additional benefit the participants will get is the set of tools and checklists which will help them to ensure that their program is ready to face an FDA inspection.

Susanne will cover the following areas at this seminar:

• Regulatory Requirements and expectations
• Elements for creating an efficient and effective CAPA Program
• CAPA process, tools, and techniques
• Linkages throughout the Quality Management System
• Root Cause Analysis
• Metrics, Control, and Monitoring
• Dissemination of Information
• Myths, Challenges, Best Practices
• Inspection Preparedness

This seminar is of immense value to professionals whose work is associated with the organization’s QMS. These include Quality Systems Specialists, Document Control Specialists, Quality and Compliance Specialists, Quality Engineers, Internal Auditors and Managers, Training Specialists, CAPA Specialists, CAPA Managers, Supplier Quality Engineers and Auditors, Quality/Compliance managers or directors for Medical Device companies, General Managers wanting to learn how to understand Quality System requirements, and Management Representatives.

Reviving cerebrum foundational microorganisms may hold key to future MS medications

Researchers have figured out how to make more seasoned cerebrum undifferentiated organisms in rodents progressively young. The disclosure could prompt improved medications for maturing related illnesses that corrupt the mind and sensory system.

The examination concerns oligodendrocyte begetter cells (OPCs), which are a kind of foundational microorganism, or juvenile cell. OPCs are basic for the sound working of the cerebrum and the remainder of the focal sensory system.

OPCs develop, or separate, into oligodendrocytes, which are the phones that produce the myelin sheath that encompasses nerve filaments and jam the electrical sign that they convey.

Annihilation of myelin is a distinctive component of numerous sclerosis (MS), and maturing related changes to OPCs add to the procedure. Maturing can likewise decrease OPC work in sound people.

Scientists at the University of Cambridge in the United Kingdom found that expanding firmness in the maturing mind hinders the capacity of OPCs.

When they transplanted OPCs from more established rodents into the cerebrums of more youthful rodents, the matured OPCs started to capacity like energetic OPCs.

Stiffening of stem cell niche:

The team eventually established that the loss of function in the OPCs was a result of something happening in their microenvironment, or stem cell “niche.”

“Here we show,” write the authors in a recent Nature paper, “that the OPC microenvironment stiffens with age, and that this mechanical change is sufficient to cause age-related loss of function of OPCs.”

It appears that the stem cell niche reflects the aging-related changes in the “chemical and mechanical signals” that it sends to the OPCs residing in it.

Once the transplanted aged OPCs sensed that they were in a more youthful, soft environment, they began to behave more like vigorous, younger OPCs.

To explore what was going on in more detail, the team ran some laboratory experiments with OPCs and “biological and synthetic scaffolds to mimic the stiffness of young brains.”

‘Molecularly and functionally rejuvenated’

The researchers observed that when they grew aged OPCs on soft material scaffolds, they started to behave more like youthful OPCs.

The aged OPCs were “molecularly and functionally rejuvenated” as a result of being on the softer material.

Conversely, placing young OPCs on scaffolds comprising stiffer material, caused them to behave like older ones.

“We were fascinated,” says co-senior study author Dr. Kevin J. Chalut, “to see that when we grew young, functioning brain stem cells on the stiff material, the cells became dysfunctional and lost their ability to regenerate, and in fact began to function like aged cells.”

Dr. Chalut works in the Department of Physics and the Stem Cell Institute at the University of Cambridge.

He observes, however, that the more interesting finding was seeing the old OPCs growing in the soft material, and how “they began to function like young cells — in other words, they were rejuvenated.”

“This suggests a new way forward to override the age-related loss of function in this important stem cell system,” he adds.

Read more at https://www.medicalnewstoday.com/articles/326066.php

US. Customs Import Rules and Export Traps in 2020

FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Other factors can derail the expectation of a seamless import entry process. The course covers detailed information about the roles and responsibilities of the various parties involved with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA’s thinking, negotiate with the FDA and offer anecdotal examples of FDA’s import program curiosities.

Why you have to study:

What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing.

The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments. CBP is implemented a new “Automated Commercial Environment” computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port.

When products are refused, you have different options. Some options may cost more than others. For example, your product can be seized and destroyed by the government. You may be fined if you do not act in a timely manner. These are common problems that become prohibitively expensive. You should know how to avoid common problems or at least how to mitigate the cost by using established and effective business planning.

Learn how to deal with common problems, such as returns for repair, importing QC samples, and investigational products

On a positive note, the FDA is implementing the Voluntary Qualification Importer Program under the FDA Food Safety and Modernization Act. One other perk is that FDA offers export certificates, for a modest fee, which may give you a competitive advantage in foreign markets. In some cases, a FDA export certificate is required by foreign governments. Finally, the new EU Medical Device Regulation will change how FDA manages foreign inspections and in your favor.

About the Instructor:

Casper (Cap) Uldriks, owns Encore Insight LLC, which provides consulting services on FDA Law. He brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed.

Register here for full details

Worldwide Blockchain Technology in Energy Market is scheduled to develop quickly in the coming years

Market Research Vision, presents the Global Blockchain Technology in Energy Market research report that gives a close summary of major players, restraints, challenges, opportunities, current business trends and methodsimpacting the world market in conjunction with estimation and forecast of revenue. This report analyzes the worldbusiness in terms of its size, status, forecast, trends, competitive state of affairs, and business opportunities.

Blockchain technology offers the way for untrusted parties to succeed in agreement on a standard digital history.

The readers can realize this report terribly useful in understanding the Blockchain Technology in Energy market comprehensive. data} and therefore the information concerning the market ar taken from reliable sources likewebsites, annual reports of the businesses, journals, et al and were checked and valid by the business specialists. The facts and information ar depicted within the report victimisation diagrams, graphs, pie charts, and alternativepictorial representations. This enhances the visual illustration and conjointly helps in understanding the facts far better.

“Blockchain Technology in Energy market research and Forecast 2019-2024” report helps the purchasers to require business choices and to know methods of major players within the business. The report conjointly entailsmarket- driven results explanation feasibleness studies for consumer desires. MarketResearchVision ensures qualified and verifiable aspects of market information operative within the real- time state of affairs. The analytical studies ar conducted making certain consumer desires with a radical understanding of market capacities within the real- time state of affairs. additionally, numerous market growth important factors like business surroundings, chop-chop increasing demand, and technological developments ar depicted during this study analysis.

Market Segmentation: world Blockchain Technology in Energy Market

– The market relies on sort, application, and geographical segments.
– supported sort, the market is divided into Public Blockchain, non-public Blockchain, syndicate Blockchain
– supported application, the market is divided into Electric Power, Petroleum, fossil fuel, Others.

A Systematic Approach to Implementing Statistical Methodologies

In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, “”…the collection and evaluation of data, from the process design stage through commercial production..” The guidance further delineates the ‘process design stage through commercial production’ into three distinct stages of the product lifecycle:

Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.

Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

Stage 3: Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

The first stage of process validation is process design. The Process Validation guidance document states, “A successful validation program depends on information and knowledge from product and process development. This knowledge and understanding is the basis for establishing an approach to control of a manufacturing process that results in products with desired quality attributes:

Manufactures should:

• Understand the sources of variation
• Detect the presence and degree of variation
• Understand the impact of variation on the process and ultimately on product attributes
• Control the variation in a manner commensurate with the risk it represents to the process and product.”

The second stage of process validation is process qualification. Although stage 2 has two elements, this course will focus on recommendations for the second element, PPQ. PPQ “combines the actual facility, utilities, equipment (each now qualified), and the trained personnel with the commercial manufacturing process, control procedures, and components to produce commercial batches.” Additionally, the process validation guidance document that “Each manufacturer should judge whether it has gained sufficient understanding to provide a high degree of assurance in its manufacturing process to justify commercial distribution of the product. Focusing exclusively on qualification efforts without understanding the manufacturing process and associated variations may not lead to adequate assurance of quality.”

The third stage of process validation is continued process verification. The process validation guidance document defines the need for this stage: “After establishing and confirming the process, manufacturers must maintain the process in a state of control over the life of the process, even as materials, equipment, production environment, personnel, and manufacturing procedures change.” Manufacturers should use ongoing programs to collect and analyze product and process data to evaluate the state of control of the process. These programs may identify process or product problems or opportunities for process improvements that can be evaluated and implemented through some of the activities described in Stages 1 and 2.”

This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance. It begins with a primer on statistics, focusing on methods that will be applied in each remaining chapter. Next, it teaches the application of statistics for setting specifications and assessing measurement systems (assays), two foundational requirements for process validation. Lastly, the course applies statistic through the three stages of process validation defined by requirements in the process validation regulatory guidance documents. Methods taught through all three stages are recommended by regulatory guidance documents; references to the specific citations in the guidance documents are provided.

Areas covered by the Instructor:

• 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.

Who will benefit by this:

• Process Scientist/Engineer
• Design Engineer
• Product Development Engineer
• Regulatory/Compliance Professional
• Design Controls Engineer
• Six Sigma Green Belt
• Six Sigma Black Belt
• Continuous Improvement Manager

Click and register for 2 day seminar