Documenting Software for FDA Submissions

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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

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.

 

Validation the complies with ICH guidelines

A clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures, and acceptance criteria in calibration limits is required from professionals in the field of statistical analysis. They also need to have a proper understanding of process and quality controls, as well as ICH Q8 and Q9.

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

When it comes to procedures and acceptance criteria in calibration limits, the ICH guideline is the ICH tripartite-harmonized ICH Guideline on Methodology, which used to be previously coded as Q2B. This was finalized in November 1996 under Step 4. This guideline extends the ICH guideline on Text, or what is called Q2A (mentioned above) to comprise 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 guideline for process and Quality Control is the Current Step 4 version of the ICH-harmonized Tripartite Guideline. The final draft of this guideline has been recommended for adoption to the regulatory bodies of the three biggest pharmaceutical markets in the world, namely the US, the EU and Japan.

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

o  Stability

o  Analytical Validation

o  Impurities

o  Pharmacopoeias

o  Quality of Biotechnological Products

o  Specifications

o  Good Manufacturing Practice

o  Pharmaceutical Development

o  Quality Risk Management

o  Pharmaceutical Quality System

o  Development and Manufacture of Drug Substances

o  Lifecycle Management.

A thorough training session on the areas of Validation in accordance with ICH guidelines

It is important and necessary for professionals in this area to get proper guidance, 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.

A seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will offer this learning. Dr. Alfred Bartolucci, who serves as Emeritus Professor of Biostatistics at the University of Alabama, will be the Director of this seminar. Please visit Validation the complies with ICH guidelinesto register for this valuable learning session. 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 clear and deep understanding of statistical concepts

Dr. Bartolucci will offer in-depth and clear learning of 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.

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

Another area of importance at this seminar is 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. It will familiarize the participants with the critical aspects of the statistical methods and explain to them the practical application of these guidelines.

Seminar Calendar of Upcoming Courses – June to July – 2017

Upcoming-Courses-for-French-Circles-Club

GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the regulatory compliance areas and to implement them, something they need to climb in their professions. GlobalCompliancePanel brings together a few of the best recognized names in the field of regulatory compliance on its panel of experts. The result: Learning that is effective, valuable and helpful.

GlobalCompliancePanel’s experts help you unravel all the knowledge you need in all the areas of regulatory compliance. At these seminars which are held all over the globe, you get to interact with them in person, so that any doubt or clarification you have is sorted out by none other than the honcho. They help professionals like you implement the regulations and stay updated, so that regulatory compliance causes no stress for you.

GlobalCompliancePanel’s experts offer their insightful analysis into the issues that are of consequence to regulatory professionals in their daily work. Their thoughts help you implement the best practices of the industry into your work. They also offer updates on the latest regulatory requirements arising out of a host of the laws and issues related to regulatory compliance, including, but not limited to medical devices, food and beverages, pharmaceuticals, life sciences, biotechnology and pharmaceutical water systems.

Take a look at our upcoming webinars from GlobalCompliancePanel, which will put you on the road to learning about any area that is of importance to your profession. You can plan your learning from GlobalCompliancePanel by looking at our seminars in the next few weeks at locations of convenience to you. You can choose from a whole range of topics. See which among these trainings suit you: Design of Experiments (DOE) for Process Development and Validation, Writing and implementing effective SOP’s, new FSMA rules, risk management and device regulations, data integrity, combination products, and what have you!

Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
Toll free: +1-800-447-9407
FAX : 302 288 6884
Website: http://bit.ly/Courses-June-to-July-2017

Validation in accordance with ICH guidelines

Chemical

Professionals in the field of statistical analysis need a clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits. Along with these, process and quality controls, as well as ICH Q8 and Q9 also need to be properly and thoroughly understood.

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

Likewise, the ICH tripartite-harmonized ICH Guideline on Methodology, which used to be previously coded as Q2B, finalized in November 1996 under Step 4, is the ICH guideline on procedures and acceptance criteria in calibration limits. This guideline extends the ICH guideline on Text, or what is called Q2A (mentioned above) to comprise 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

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

In order to achieve harmonization in Quality, professionals have to meet critical milestones. These include conducting stability studies, the way the studies define relevant limits for the testing of impurities, and following a more malleable approach to pharmaceutical quality that is based on the principles of Good Manufacturing Practice (GMP) risk management. ICH’s Quality guidelines on harmonization relating to Quality cover the following areas:

Get professionally trained 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 necessary and important to undergo professional trainings with which professionals in these areas can clarify a number of doubts.

This is the learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will be imparting. This training will be led by Dr. Alfred Bartolucci, who serves as Emeritus Professor of Biostatistics at the University of Alabama. To enroll for this seminar, please register by logging on to Validation in accordance with ICH guidelines . 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 clear and deep understanding of statistical concepts

Depth and clarity of understanding of 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, along with ICH Q8 and Q9 will be the main thrust of this seminar.

This seminar is not a course in statistics, but offers an introduction to an applied approach to the statistical techniques used, and how to reasonably interpret them. This learning will help participants address the various challenges facing pharmaceutical and biotechnology companies when they have to quantify results in a meaningful interpretable manner through tabulations and graphical presentations.

In addition, Dr. Bartolucci will also focus on another important area: What the different regulatory agencies expect of the quantification and development of a sound statistical monitoring of a properly utilized, effective, and efficient process control. He will familiarize the participants with the critical aspects of the statistical methods and explain to them the practical application of these guidelines.

 

GlobalCompliancePanel announces Seasonal offers for Professionals with Flat 50% OFF on all Seminars

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Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a massive 50% discount!

Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till April 30. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit https://www.globalcompliancepanel.com/seminar?wordpress_SEO and use MGCP50 Promo Code.

This offer is valid till April 30, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

These regulatory requirements can pose hurdles to the most experienced and brightest of regulatory compliance professionals in the medical devices, pharmaceutical, life sciences and food and biologicals areas, but not to those who undertake professional trainings from GlobalCompliancePanel. GlobalCompliancePanel’s panel of experts is here to help them overcome these challenges and hurdles.

This trend has been being witnessed from the time GlobalCompliancePanel entered the line of professional trainings. Any wonder then, that no fewer than 50,000 professionals have benefited from these trainings? What could be a better way of thanking such a huge base of customers than with this offer? GlobalCompliancePanel believes that a celebration should also be useful, and this is that this offer is!

Hurry up and enroll today. Happy learning!

 

 

Ensuring that analytical data in laboratories are accurate, reliable and consistent

Ensuring that analytical data are reliable, consistent and accurate is the fundamental reason for which analytical methods and procedures need to be validated. The employment of proper scientific methods and procedures by laboratories and validating them ensures the reliability, consistency and accuracy of the analytical data.

The purpose of doing so is to corroborate the suitability of intended use of a particular test and to confirm that the product produced in the laboratory meets the requirements of quality, purity, identity and strength in the required and set measure.

The imperative for validation of analytical data

The reason for which analytical data has to be validated for the criteria described above can be summarized in the following:

o  Because of the direct relationship it has to the quality of the data it validates;

o  To make sure that the analytical data is trustworthy;, and

o  Finally, validation, verification and transfer of analytical methods are a regulatory requirement, as set out by the different regulatory bodies such as the FDA and the EMA, and standards such as the USP and ICH.

Method validation and compendial methods

Of late, method validation has been receiving very high attention from both regulatory agencies and industry task forces alike. Both the FDA and the EMA have recently released guidelines on method validation and transfer. In addition, USP has suggested new chapters for approaches to the following:

o  Integrated validation

o  Verification and transfer of analytical procedures

o  Equivalency testing and for statistical evaluation.

What about compendial methods?

The verification of compendial methods is needed to demonstrate two aspects:

o  The suitability of laboratories to successfully run the method, and

o  To demonstrate through testing that transfer of methods, when carried on between laboratories, is successful. When a laboratory intends to use an alternative method in place of a compendial method, verification of compendial measures should establish the equivalency of the alternative method.

Comprehensive learning on validation, verification and transfer of analytical methods

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance will address all the issues relating to validation, verification and transfer of analytical methods. At this seminar, Ludwig Huber, the director and editor of Labcompliance, the global online resource for validation and compliance and highly respected author of several books on compliance, will be Director.

To gain the full knowledge of all areas relating to validation, verification and transfer of analytical methods; register by logging on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900858?linkedin-SEO .

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

Contents of the two-day seminar

Over the course of these two days, Huber will equip participants with the background needed for getting a proper understanding of the requirements that need to go into validation, verification and transfer of analytical methods. An even more significant learning he will offer is the one on strategies needed for this.

He will provide tools to implement most critical requirements. Also provided are templates and examples for developing inspection-ready documentation. Interactivity will be a major component of this seminar. Huber will sprinkle workshop exercises into and between the presentations. Around half of the total time will be dedicated to practical sessions with real life examples.

An additional bonus for participants is the assortment of tools the Director of this seminar will offer, such as SOPs, validation examples and checklists, all of which will be made readily available on a dedicated website, and which can be used to easily implement the learning gained in the course.

Validation of Pharmaceutical Water Systems

validation-of-pharmaceutical-water-systems1

Thorough and proper validation of pharmaceutical water systems is highly essential for ensuring that the pharmaceutical unit uses the right quality of water. This is very important, because water is not only the source of life for humans; it enjoys the same importance in pharmaceuticals.

A very important reason for which validation of pharmaceutical water systems is necessary is that water is not only the most widely used raw material or substance in pharmaceuticals; it is also put to a number of uses in the pharmaceutical industry, such as Quality Control, process, production and formulation. Further, water comes with its own set of unique chemical properties that are obtained because of the hydrogen bonds present in it and its polarity. This makes water versatile, since it allows the dissolution, absorption, adsorption or suspension of various different compounds.

Process for pharmaceutical water systems validationvalidation-of-pharmaceutical-water-systems

Validation of pharmaceutical water systems is carried out in three phases:

Phase I, which is the investigational phase

Phase II, the short term control phase, and

Phase III, which is the long-term control phase

Pharmaceutical water systems are validated through these three steps or stages to demonstrate and ensure that the facility using pharmaceutical water systems has water under its control and is on the right track for production of the right quality and quantity of water in the short, medium and long terms.

Validation through commissioning and qualificationPharmaceutical water systems validation is carried out through two important steps, namely commissioning and qualification. Commissioning is about putting the validation of pharmaceutical water systems through the required phases using the prerequisite methods of documentation. This documentation is a core part of pharmaceutical water systems validation because it allows for different personnel in the organization to not only keep track of the processes involved, but also make changes when necessary.

Qualification as part of pharmaceutical water systems validationQualification is the next important stage of pharmaceutical water systems validation. Here, before a pharmaceutical water systems validation process is started, the pharmaceutical facility should implement the following important steps:

  • Design qualification (DQ)
  • Installation qualification (IQ) and
  • Operational qualification (OQ)

Phase I:In Phase I, the pharmaceuticals facility samples and tests water sampling for anywhere between two and four weeks for monitoring the water system. If the water system is free of failure during this phase, it is considered a successful phase of pharmaceutical water systems validation.

Phase II:In this phase of pharmaceutical water systems validation too, the water system sample is tested intensively for two to four weeks, during which the water sample should show that it is producing the right quantity of water under conditions of stated SOP.

Phase III:Phase III of pharmaceutical water systems validation is the longest and most arduous period, running to one year after completion of Phase I and Phase II. When the water sample passes through this phase, it is said to have completed the process of pharmaceutical water systems validation and is considered fit for pharmaceutical use.

Learn more on this topic by visiting : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900882SEMINAR?wordpress-SEO