Become Better With Biostatistics for the Non-Statistician In 10 Minutes

That statistics can be a vital decision-making tool for clinical research is well-established. It is helpful for the clinician in situations where a p-value can help determine the next steps in the development of a drug or procedure. It is thus vital for decision makers to comprehend the theory and application of statistics.

We have many statistical software applications that help in arriving at crucial decisions. However, almost all these software applications were developed for statisticians. These software applications could confound the non-statisticians. Their confusion could start with something as basic as even knowing which key to press.

In this scenario, learning how to use biostatistics and derive its benefits is important. A marathon, six-hour webinar being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, on October 25, will explain biostatistics for the non-statistician.

Elaine Eisenbeisz, a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California, will be the expert at this webinar. Please visit https://www.globalcompliancepanel.com/virtual-seminar/6-hour-virtual-seminar-on-biostatistics-for-the-non-statistician-10307LIVE to register for this webinar.

—————————————————————————————————————-

This webinar, designed for non-statisticians, provides a non-mathematical introduction to biostatistics. Elaine will arm the participants with all the information and skills necessary for understanding statistical concepts and findings as they apply to clinical research, and to confidently convey this knowledge to people with whom they work.

This webinar will emphasize statistical concepts, application, and interpretation, and not on mathematical formulas or actual data analysis. Participants are expected to have an elementary understanding of statistics, but this is not mandatory.

It is aimed at professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

This will be the agenda that will be covered at this webinar:

Why Statistics?

• Do we really need statistical tests?
• Sample vs. Population
• I’m a statistician not a magician! What statistics can and can’t do
• Descriptive statistics and measures of variability

The many ways of interpretation

• Confidence intervals
• p-values
• effect sizes
• Clinical vs. meaningful significance

Common Statistical Tests

• Comparative tests
• Regression analysis
• Non-parametric techniques

Bayesian Logic

• A different way of thinking
• Bayesian methods and statistical significance
• Bayesian applications to diagnostics testing
• Bayesian applications to genetics

Interpreting Statistics – Team Exercise

• Team Exercise: Review a scientific paper and learn how to
  • Interpret statistical jargon
  • Look for reproducibility, transparency, bias, and limitations
  • Convey information coherently to non-statisticians

Study power and sample size

• Review of p-value, significance level, effect size
• Formulas, software, and other resources for computing a sample size

Developing a Statistical Analysis Plan

• Using FDA guidance as a foundation, learn the steps and criteria needed to develop a statistical analysis plan (SAP).
• An SAP template will be given to all attendees.

Specialized topics/Closing Comments/Q&A

• Comparing Survival Curves
• Pharmacokinetics/Pharmacodynamics (PK/PD)
• Taking a holistic view to study design and interpretation
• Question and Answer session.

—————————————————————————————————————–

About the Director:

Elaine brings over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations to start-up companies and individual researchers. She has designed the methodology for numerous studies in the clinical, biotech, and health care fields.

She currently is an investigator on approximately 10 proton therapy clinical trials for Proton Collaborative Group, based in Illinois. She also designs and analyzes studies as a contract statistician for nutraceutical and fitness studies with QPS, a CRO based in Delaware.

Cleaning Validations Using Extraction Techniques

Cleaning validations are an essential step in the medical device development process. One of the most common methods is using extraction techniques to validate the cleanliness of a device. This webinar will provide valuable guidance on how to achieve a thorough validation of a cleaning process.

Why should you attend:Medical device manufacturers have always been under scrutiny to ensure that their product does no harm to the patient. Regulatory agencies have become increasingly aware of the potential dangers of residual manufacturing materials on medical devices. Therefore, cleanliness has become a hot topic in the medical device community. A thorough validation of the cleaning processes used to remove residual materials from newly manufactured medical devices is necessary to ensure patient safety.

Areas Covered in the Session:

• Cleaning Validation Overview
• Defining the Scope
• Identifying the Contaminants
• Choosing the Test Method
• Choosing the Solvents
• Setting Extraction Parameters
• Validating the Extraction
• Setting Limits

Who Will Benefit:

• QA/QC Managers and Personnel
• Validation Managers and Personnel

Speaker Profile

Kierstan Andrascik has worked in the medical device industry for more than 12 years. She founded QVET Consulting in 2009 to assist medical device manufacturers with their validation needs. She specializes in cleaning validations for both new and reprocessed medical devices and has established herself as one of the foremost experts in medical device cleanliness. She also provides guidance in many other areas including sterilization, biocompatibility, packaging, and materials characterization.

Previously, she worked at Nelson Laboratories in Salt Lake City, Utah where she served as study director covering a variety of testing including new device cleaning validations, materials characterization, and package testing. In 2002, she began developing a method to quantify residual manufacturing materials on medical devices. In 2005, ASTM published a similar method as F2459. Kierstan has been actively serving on the ASTM Device Cleanliness subcommittee since 2005. She received a Certificate of Achievement from ASTM in May 2007. In the June 2008 issue of Medical Design magazine, her article titled “How to tell if a device is really clean” was published. Then, in April 2011, her chapter “Cleaning Validations using Extraction Techniques” published in the 2nd edition of Handbook for Critical Cleaning. She has a BS in chemistry and mathematics, and an AS in Engineering from Shepherd University in Shepherdstown, West Virginia.

Click Here to Continue Learning

Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use

The complexity and vulnerability of software is expanding exponentially, so fast that Congress removed some device software from FDA’s jurisdiction. The remaining software regulated by FDA presents a degree of a risk to health that creates a public health concern. Part of that risk involves the intentional activity that can conflict, intrude or destroy software. The problems are taking center stage in the “healthcare software” dialogue. What issues can compromise or defeat the functional use of your software? Poor cybersecurity programs, lack of interoperability with third-party software, the wave of unmanageable apps and wireless home use technology. Original software design for an intended use is only the first step, the next design step is thinking about how someone can make your software worthless.

FDA’s changing regulatory controls

Cybersecurity management by design, oversight and preventive action

Ransomware attacks and recovery

Use voluntary standards and NIST

Mobile apps regulated and those not regulated

Wireless/home use software systems and human factors

Who will get the benifit with this

• Business Planning Executives
• Regulatory Directors
• Software design and specification developers
• Real time software performance auditors
• Recall managers
• In-house Legal Counsel
• Customer support and service directors
• Contract Specialists
• Business acquisition Managers
• Hospital Risk Managers

Know more at http://bit.ly/2CbGREq

200+ followers. WOWWWWWW…

Hello Everyone,

Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community.

we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!

we would continue our blogging in these areas FDA Regulation, Medical Devices, Drugs and Biologics, Healthcare Compliance, Biotechnology, Clinical Research, Laboratory Compliance, Quality Management ,HIPAA Compliance ,OSHA Compliance, Risk Management, Trade and Logistics Compliance ,Banking and Financial Services, Auditing/Accounting & Tax, Packaging and Labeling, SOX Compliance, Environmental Compliance, Microsoft Excel Spreadsheet, Geology and Mining, Human Resources Compliance, Food Safety Compliance and etc.

Get more article – https://www.globalcompliancepanel.com/freeresources/resource-directory

Please follow us on

Facebook – https://www.facebook.com/TrainingsAtGlobalCompliancePanel

Twitter – https://twitter.com/gcpanel

LinkedIn – https://www.linkedin.com/company/10519587/admin/updates/

Process Development and Validation rest on the right Design of Experiments and Statistical Process Control

The application of DOE and SPC to the development, design and monitoring of manufacturing and testing requires the use of procedures. Why? It is because in a recent guidance document on Process Validation, the FDA has named the Quality Unit as being responsible in the review and interpretation of DOE and SPC studies.

The Quality Unit needs to take a practical orientation when it sets out doing this work. An approach in which case studies and examples are sprinkled goes a long way in helping Process Validation professionals in their work. This is exactly what a seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will offer and help regulatory professionals in the Quality Control and Quality Assurance areas achieve their aims.

The Director of this two-day seminar is Dr. Steven Kuwahara, who Founder and Principal, GXP BioTechnology LLC. Want to understand ways by which to adapt the right approach to applying DoE and SPC to the development, design and monitoring of manufacturing and testing? Then, please register for this very useful session by logging on to Process Development and Validation rest on the right Design of Experiments and Statistical Process Control . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Completely interactive

Dr. Kuwahara will do full justice to the role and importance of practical experiments in aiding an understanding of Design of Experiments. Theoretical information will be given only when it is needed to help gain an understanding of an experiment. At this highly interactive and practical session, Dr. Kuwahara will offer examples from real processes and testing procedures. He will intersperse these with examples that will be directly applicable to the areas of work that relate to the participants of this seminar.

An understanding of the way the process parameters relate to and work with each other is necessary for any pharmaceutical worker who is involved in performing, supervising or reviewing manufacturing or testing processes. The ability to monitor the performance of processes and test methods is also needed for such a worker. While this is true for a professional in any department of pharmaceuticals; it applies more to the worker who works in Quality Control and Quality Assurance, a requirement that has become necessary following the passage of recent FDA guidance document on Process Validation.

However, it is the development, manufacturing, or quality systems worker who carries out this work. In view of this fact, a high degree of coordination is needed between these two levels of employees. At this seminar, Dr. Kuwahara will arm these two levels of employees with the knowledge of the ways of designing the systems and studies, and then interpreting the results generated.

Dr. Kuwahara has charted out the following agenda for this seminar:

Dietary Design of Experiments

• Introduction
• One Level, One Factor Designs. Simple Comparisons
• Two-Level Multi-Factorial Design
• Extracting Information from the Experiment

Statistical Process Control

• Shewhart Charts for Variable Data
• Shewhart Charts for Attribute Data Especially Counts
• Considerations from Shewhart Charts
• Other Types of Charts Related to Shewhart Charts

This seminar is designed for the benefit of professionals involved in the procedures and applications of DOE and SPC, such as Directors, Managers, Supervisors, Lead workers in Process Development, Manufacturing, Regulatory Affairs, Quality Assurance and Quality Control, and workers who participate in operations or the are involved in the supervision of the development, manufacturing, or testing of medicinal products.

To join us for more information, get in touch

21 CFR Part 11 compliance requirements for software validation and SaaS/Cloud

 

Software as a Service, SaaS, is a way by which applications are delivered over the Net. It provides Software as a Service using just the Internet, and hence the name. SaaS applications are known by varied names. On-demand software, hosted software, and web-based software are some of these.

Where SaaS differs as a method of delivering applications is that there is no need to install and maintain software at or from the client’s location. All that is needed to access all these is an Internet connection. The provider can run SaaS applications on his own servers. With the provider taking over the responsibility of managing all aspects of the application, such as making it available and secure, and also for its performance; the client is spared the hassle of having to manage unfamiliar and often complex software and hardware.

Given this novelty and ease of its application; SaaS has grown into a huge market. Its US market was estimated at just over $ 10 billion in 2011. In the next couple of years, the global SaaS market is set to grow to around $ 120 billion. Experts put its speculated CAGR at between 18 and 24 percent and expect SaaS to make up more than one fifth of all software services by 2019.

Now, the difficult part of SaaS

All these bright spots about SaaS notwithstanding; it comes with a few hiccups. Given its nature, most SaaS providers outsource their resources to cut costs. This makes them very vulnerable, since most regulations, such as 21 CFR Part 11, apply only to the provider, and give little by way of safeguards to the vendor. With very less vigilance and scrutiny on the vendor; the onus of ensuring compliance for both infrastructure qualification and Computer System Validation lies with the regulated company, for it is they who have to show compliance with the regulations and prevent issues relating to availability, performance and protection of data.  In other words, while the actual work of SaaS is carried on by the vendor; it is the client who has to ensure compliance with regulations arising out of 21 CFR Part 11.

Since on paper it is the regulated provider to whom all the regulations apply; it becomes the target of FDA inspections on software validation. They have to show compliance with these regulations set out in 21 CFR Part 11 and other regulations such as Annex 11 if they have to avoid FDA actions such as Warning Letters and 483’s. There is thus a major need for regulated companies, software vendors and SaaS/cloud providers to show compliance with 21 CFR Part 11. This is the only way to avoid legal and other issues associated with noncompliance.

The ways of staying compliant

This is what a two-day seminar that is being organized by GlobalCompliancePanel, a highly regarded provider of professional trainings for the regulatory industries, will offer. This seminar will explain in-depth how regulated companies, software vendors and SaaS or cloud providers can ensure compliance and safeguard and enhance their reputation as trustworthy providers

David Nettleton, who is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and Computer System Validation, will be the Director of this seminar.

Please register for this webinar by visiting 21 CFR Part 11 compliance requirements for software validation and SaaS/Cloud. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

An explanation of proven techniques

Over the two days of learning at this seminar, David will demonstrate proven techniques for cutting costs associated with the implementation, usage, and maintenance of computer systems in regulated environments. In doing this, David will address the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and Computer System Validation.

With the FDA performing both GxP and Part 11 inspections; the EMA has released an updated Annex 11 regulation that expands Part 11 requirements. Companies must update their systems and processes to maintain compliance. This aspect will be explained at this seminar. The Director will offer participants an understanding of the specific requirements associated with local and SaaS/cloud hosting solutions.

Validation in several specialized areas

The regulatory agencies require almost every computerized system used in laboratory, clinical, manufacturing settings and in the quality process to be validated. David will show the ways by which they can do this while decreasing software implementation time and lowering costs using a 10-step risk-based approach to Computer System Validation. He will review recent FDA inspection trends and discuss how to streamline document authoring, revision, review, and approval.

This seminar is of high value to anyone who uses computer systems to perform their job functions in the regulatory, clinical and IT areas of health care, clinical trial, biopharmaceutical, and medical device sectors. Software vendors, auditors and quality staff involved in GxP applications will also derive high value from this seminar.

 

NetZealous LLC DBA GlobalCompliancePanel Media Partner with SocialMediaPortal:

 

Global News and Information Directory

 

 

 

It is important and necessary to document Software for FDA Submissions

Software project management has an important tool in the Agile methodology. The Agile methodology developed as a product of the gradual efforts at arriving at a team based methodology of iterative software development. Because of its close association with software, in terms of suitability; Agile is to software development what Lean is to manufacturing. Among the many areas in which the Agile methodology is very well suitable and adaptable; healthcare is one, since it uses software heavily.

The Agile methodology is effective in helping software project managers anticipate and address major logjams of software project management, such as vulnerability and unpredictability. By preventing project delays; Agile helps to cut costs. Since flexibility is an important characteristic of Agile; it has the ability to accommodate and take in many new changes that take place as the project develops.

Another major benefit of Agile is that it prevents piling of work at later stages of the project by reviewing project progress at every stage by validating roles, steps and processes functions. This is absolutely useful in the backdrop of severe constraints of time and money, because of which it is highly preferred and rated by Project Managers.

Is Agile perfect?

All these terrific advantages notwithstanding; Agile is not perfect. It is not suited in every setting and in every situation. If Agile has to be efficient and deliver its results optimally; it has to work in conditions where there is complete, tightly knit team coordination. In the absence of very active and strong participation from the team leaders, subject matter experts and stakeholders; Agile can prove less than suitable or successful.

Agile’s suitability for the healthcare industry is well-established. However, Agile, being a highly teamwork-dependent initiative can fail to deliver in the absence of one or more situations in which it thrives. In the absence of complete confidence by those using it in the healthcare industry of its role in saving money, time and other resources; the Agile methodology can be less than useful

Get to learn the applicability of Agile methodology to healthcare

The ways by which the healthcare industry can adapt and optimize Agile methodology for its use and overcome the deficiencies and shortfalls of this methodology for enhanced performance will be the topic of a very interesting two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance.

The Director of this seminar is Brian Shoemaker, who consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures, and has worked with companies in Germany and Switzerland as well as the U.S. Please register for this session by logging on to It is important and necessary to document Software for FDA Submissions. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Clarity on the suitability of Agile to IEC 62304

A criticism that does the rounds in healthcare software industry circles is that Agile, because of its lack of documentation, runs counter to the lifecycle standards mandated in IEC 62304. Brian will clarify on this area and explain how clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution, which go into the IEC 62304 principles actually reinforce, rather than undermine the Agile methodology. The proof of this fact is that the AAMI Agile report (TIR 45) has stated that the proper application of Agile, with its emphasis on nimbleness and ongoing learning, into a quality system and safety risk management can blend with and expedite the fulfilment of regulatory expectations of well-documented development.

Contrary for popular belief, documentation in Agile actually helps in taking advantage of iterative development. How? Since the IEC 62304 does not specify any lifecycle model; documentation can grow out of the required iterative activities. Agile, by developing incrementally and preventing last minute anxieties and worries; is highly useful in many disciplines of healthcare such as hazard analysis. When risk management is included in iteration tasks; it becomes more robust and solid.

It is because of all these reasons that this is a session that professionals across a wide spectrum of positions such as Regulatory Specialists, Quality Assurance Specialists, Documentation Specialists, Test Managers, Software Team Leaders and Lead Developers, and Project and Program Managers ought not to miss out on.

They will get thoroughly familiarized on the applicability of the Agile methodology to software documentation for FDA submissions. Over these two days of this seminar, Brian will cover the following areas:

• Agile vs IEC 62304: an apparent contradiction?
• The role and value of documentation
• The REAL regulatory requirements
• Specific documents required for an FDA submission
• Areas where most development processes bog down
• Iteration – well suited for risk, usability, and design reviews
• Key practices to bridge the Agile and regulated worlds
• Agile is not only acceptable for medical device software, but can be clearly superior.

 

 

Understanding 21 CFR Part 11 compliance for software validation and SaaS/Cloud

Software as a Service, SaaS is a method of delivering applications over the Internet. This small definition just about summarizes the core of SaaS: It provides Software as a Service using just the Internet. SaaS applications go by different nomenclatures such as on-demand software, hosted software, or web-based software.

SaaS is a fundamentally different method of delivering applications, because when a client chooses SaaS; there is no need to install and maintain software. It can be accessed with just an Internet connection. SaaS applications can be run on the provider’s servers. Since it is the provider who takes over the responsibility of managing all aspects of the application, such as making it available and secure, and also for its performance; the client is spared the headache of having to manage unfamiliar and often complex software and hardware.

This sunny side of SaaS appeals to many clients, which is the primary reason for which SaaS is a huge market. From over $ 10 billion in 2011 in the US; the global SaaS market is set to grow to around $ 120 billion by 2019. Speculated to grow at a CAGR of anywhere between 18 and 24 percent; SaaS is estimated to make up more than one fifth of all software services by that year.

The difficult side of SaaS

This makes the prospects for the SaaS market very bright. However, there is a catch: Most SaaS providers outsource their resources to cut costs. This activity exposes them to the seamy side of this exploding market. Most regulations such as 21 CFR Part 11 are only for the provider, and very little of these are for the vendor. Since there is very less regulation that will offer safeguards to the user from the vendor; the onus of ensuring compliance for both infrastructure qualification and Computer System Validation lies with the regulated company, for it is they who have to show compliance with the regulations and prevent issues relating to availability, performance and protection of data.

Failure in doing so hurts their reputation, because it is they, and not the vendor, that is regulated. This regulated provider is the one that becomes the target of FDA inspections on software validation and should hence do everything it can to avoid FDA actions such as Warning Letters and 483’s. There is thus a major need for regulated companies, software vendors and SaaS/cloud providers to show compliance with 21 CFR Part 11 and other regulations such as Annex 11. This is the only way to avoid legal and other issues associated with noncompliance.

Learn the ways of staying compliant

How do regulated companies, software vendors and SaaS or cloud providers ensure compliance and safeguard and enhance their reputation as trustworthy providers? It is this critical issue that will be discussed threadbare at a very useful and educative two-day seminar that is being organized by GlobalCompliancePanel, a highly regarded provider of professional trainings for the regulatory industries.

At this seminar, David Nettleton, who is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and Computer System Validation, will be the Director.

Want to understand how David explains the way by which regulated companies can offer legally compliant SaaS and cloud solutions? Then please register for this seminar by logging on to Understanding 21 CFR Part 11 compliance for software validation and SaaS/Cloud. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Demonstrating proven techniques

The purpose of this seminar is to demonstrate proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Towards imparting this, David will address the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and Computer System Validation.

With the FDA performing both GxP and Part 11 inspections; the EMA has released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance. David will discuss this. He will give participants an understanding of the specific requirements associated with local and SaaS/cloud hosting solutions.

Validation in a number of specialized areas

Since almost every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated; the ways by which they can decrease software implementation times and lower costs using a 10-step risk-based approach to Computer System Validation will be imparted. The Director will review recent FDA inspection trends and discuss how to streamline document authoring, revision, review, and approval.

Anyone who uses computer systems to perform their job functions in the regulatory, clinical and IT areas of health care, clinical trial, biopharmaceutical, and medical device sectors will find this seminar highly useful. It is of high value for software vendors, auditors, and quality staff involved in GxP applications.

 

 

Implementing ICH guidelines-compliant validation

Professionals in the field of statistical analysis need to possess clarity on understanding and interpreting statistical concepts used to investigate quantitative ICH Guidelines, such as:

• Analytical methods validation
• Procedures and acceptance criteria in calibration limits
• Process and Quality Control
• Process and quality controls
• ICH Q8 and Q9.

The ICH tripartite-harmonized ICH Guideline on Text, which was previously coded as Q2A guideline, is the guideline the ICH has set out for analytical methods validation. It was finalized in October 1994 under Step 4. Identification of the various validation parameters that are required for a number of analytical methods is the aim of this guideline. It also lays down the characteristics and parameters that have to be taken into consideration when validating the analytical procedures that are included in the registration applications.

ICH tripartite-harmonized ICH Guideline on Methodology, which used to be previously coded as Q2B is the ICH guideline for procedures and acceptance criteria in calibration limits. Finalized in November 1996 under Step 4; this guideline extends the ICH guideline on Text, or what is called Q2A (mentioned above). It comprises the actual experimental data required, along with the statistical interpretation, for the validation of a variety of analytical procedures.

Current Step 4 for process and Quality Control

The Current Step 4 version of the ICH-harmonized Tripartite Guideline is the current guideline for process and Quality Control. The regulatory bodies of the three biggest pharmaceutical markets in the world, namely the US, the EU and Japan have recommended the final draft of this guideline for adoption.

Professionals who want to achieve harmonization in Quality Meeting are required to meet critical milestones. These milestones include conducting stability studies, understanding the way the studies define relevant limits for the testing of impurities, and following a more flexible approach to pharmaceutical quality that is based on the principles of Good Manufacturing Practice (GMP) risk management. The ICH’s Quality guidelines on harmonization relating to Quality cover the following areas:

• Stability
• Analytical Validation
• Impurities
• Pharmacopoeias
• Quality of Biotechnological Products
• Specifications
• Good Manufacturing Practice
• Pharmaceutical Development
• Quality Risk Management
• Pharmaceutical Quality System
• Development and Manufacture of Drug Substances
• Lifecycle Management.

Complete learning on the areas of Validation in accordance with ICH guidelines

Considering the complexity and the breadth of the issues associated with these techniques, which cover both the pharmaceutical and clinical applications, and considering that these techniques apply to a number of area such as stability testing, outlier analysis and risk management; it is important and necessary for professionals in this area to get proper guidance on validation.

GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will offer this learning at a seminar that it is organizing. The Director of this seminar is Dr. Alfred Bartolucci, who serves as Emeritus Professor of Biostatistics at the University of Alabama. To register for this seminar, please visit Implementing ICH guidelines-compliant validation. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A thorough understanding of statistical concepts

The statistical concepts used for investigating quantitative ICH Guidelines, such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and Quality Control, as well as with ICH Q8 and Q9, will all be covered in depth at this seminar.

Although not a formal course in statistics, this seminar will offer an applied approach to the statistical techniques used and will show how to reasonably interpret them. This learning will help participants to address the various challenges facing pharmaceutical and biotechnology companies when they are required to quantify results in a meaningful interpretable manner through tabulations and graphical presentations.

The expectations of different regulatory agencies regarding the quantification and development of a sound statistical monitoring of a properly utilized, effective, and efficient process control will also be taken up for discussion at this seminar. Dr. Bartolucci will familiarize the participants with the critical aspects of the statistical methods. He will explain the practical application of these guidelines.

This seminar will offer the following learning objectives:

• Evaluate linear quantitative measurement procedures and sources of error
• Distinguish the difference between confidence and tolerance intervals
• Evaluate the appropriateness of the effect of sample size in given procedures
• Evaluate laboratory/clinical quality control based on risk management
• Interpret statistical process control
• Distinguish between FDA requirements and ICH guidelines.

 

 

 

 

 

Documenting Software for FDA Submissions

The Agile methodology is an important tool for software project management. It emerged out of the gradual efforts at arriving at a team based methodology of iterative software development. Its close association with software makes it as suitable to this field as Lean is to manufacturing. Healthcare is one of the many areas in which the Agile methodology is very well suitable and adaptable.

The Agile methodology can be used to help software project managers forestall and address major bottlenecks of software project management, such as vulnerability and mercuriality. It helps to prevent project delays and thus cuts costs. An important feature of Agile is its flexible nature, which gives it the ability to accommodate and ingest many new changes that take place as the project develops.

In reviewing project progress at every stage by validating roles, steps and processes functions; Agile prevents piling of work at later stages of the project. Protect managers have reiterated time and again the ability Agile has in the background of severe constraints of time and money.

Agile has its drawbacks

However, this is not to suggest that all is well with Agile, and that it works in every setting and in every situation. For Agile to work efficiently and to deliver the results it sets out to; the most essential precondition is thorough and complete, tightly knit team coordination. It requires very active and strong participation from the team leaders, subject matter experts and stakeholders.

The suitability that Agile has for the healthcare industry is well-established. But, being a highly teamwork-dependent initiative; Agile also has the potential to fail in situations in which all the factors that make it work fail to gel or synchronize. Unless those in the healthcare industry who want to use Agile methodology as a means for saving money, time and other resources are confident that they can bring together all that is needed for making Agile methodology useful and effective; it is not going to be of much use.

A learning session on the applicability of Agile methodology to healthcare

So, how does the healthcare industry adapt Agile methodology for its use? How does it overcome the deficiencies and shortfalls of this methodology to optimize its use and leverage it for better results?

An in-depth exploration how Agile methodology can help in documenting software for FDA submissions will be the core learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering.

Brian Shoemaker, who consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures, and has worked with companies in Germany and Switzerland as well as the U.S., will be the Director of this seminar. Please visit Documenting Software for FDA Submissions 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.

Clarification of doubts about the suitability of Agile to IEC 62304

At this seminar, Brian will clarify the criticism in healthcare software industry circles that Agile, because of its lack of documentation runs counter to the lifecycle standards mandated in IEC 62304. He will explain how clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution, which go into the IEC 62304 principles actually strengthen, rather than weaken or controvert the Agile methodology. In fact, as the AAMI Agile report (TIR 45) has stated, the proper application of Agile, with its emphasis on nimbleness and ongoing learning, into a quality system and safety risk management can meld with and facilitate in fulfilling regulatory expectations of well-documented development.

In fact, documentation in Agile actually helps in taking advantage of iterative development. This is because since the IEC 62304 does not specify any lifecycle model; documentation can grow out of the required iterative activities. By developing incrementally and helping prevent last minute anxieties and worries; Agile is highly useful in many disciplines of healthcare. Its use for hazard analysis is extremely well suited. This makes risk management more robust by being included in iteration tasks.

In all, this will be a highly educative session at which all the aspects relating to the applicability of the Agile methodology to software documentation for FDA submissions will be explained. Brian will cover the following areas at this seminar:

• Agile vs IEC 62304: an apparent contradiction?
• The role and value of documentation
• The REAL regulatory requirements
• Specific documents required for an FDA submission
• Areas where most development processes bog down
• Iteration – well suited for risk, usability, and design reviews
• Key practices to bridge the Agile and regulated worlds
• Agile is not only acceptable for medical device software, but can be clearly superior.