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.

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200+ followers. WOWWWWWW…

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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.

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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

Drug dissolution testing and establishing plasma drug levels in humans

Dissolution testing is a very important tool that determines and help understand the performance and effectiveness of oral solid dosage forms. It is significant for the field of medicine because if a drug has to be effective, it must be released first from the product form, and it should then be allowed to get dissolved in the gastrointestinal fluids. This is the first step that leads to the next important phase, that of the dosage’s absorption into the bloodstream. This points to the fact that dissolution from the dosage form is a major determinant of the rate and extent to which the drug gets absorbed by the body.

Drug dissolution testing is very important during the development of drugs and drug formulations. It helps to determine if the right concentration of the drug reaches the desired or expected locus of action. This makes the investigation of the factors which affect drug absorption into the human blood flow when a drug product is taken orally important.

The usual method of measurement of drug absorption is in vivo, or, the body of a living being such as a human or animal. Time blood plasma concentration profiles of drugs after oral administration constitute an important in vivo parameter. In-vitro investigations are carried out for identifying the parameters involved in drug absorption. These are investigations that are conducted in a controlled and simulated environment that resembles biological conditions closely.

Thorough learning of drug dissolution

An important seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer valuable learning on all the aspects of drug dissolution testing and explain the ways of establishing plasma drug levels in humans.

At this two-day seminar, Dr. Saeed Qureshi, who has worked as a research scientist with Health Canada and is an internationally known expert on the subject whose expertise spans the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products; will be the Director.

In order to gain the benefit of learning from this world-renowned expert, please enroll for this seminar by visiting Drug dissolution testing and establishing plasma drug levels in humans. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

All aspects of drug dissolution and establishing plasma drug levels

This seminar will provide its participants a unique opportunity to learn scientifically valid drug dissolution testing and establishing plasma drug levels. Lab personnel take several approaches to conduct dissolution testing using different apparatuses and methods. This makes section of an appropriate apparatus and method confusing and challenging. Dr. Qureshi will offer relevant pharmacokinetics and physiological background that is aimed at making this choice easier and intuitive. He will use simple and clear language in helping participants understand how to select or develop a dissolution method. He will describe the theoretical aspect of the drug dissolution testing, including method development, in detail. He will explain the pros and cons of different approaches.

Another important area that Dr. Qureshi will address is in vitro-in vivo correlation (IVIVC). He will address the particular issue of the use of the concepts of convolution/deconvolution and IVIVC in providing an estimate/prediction of expected drug levels in humans through drug dissolution testing. This approach has met with limited success. Dr. Qureshi will explain the reasons for this and suggest alternative approaches and will offer an explanation of the underlying scientific principles involved in convolution, deconvolution and IVIVC techniques with simple practical examples. He will describe a unique and simple approach based on convolution technique using spreadsheet software.

He will show in vitro drug dissolution testing and convolution/deconvolution techniques for predicting plasma drug levels using the principles of pharmacokinetics and physiology. Dr. Qureshi will cover the following main areas at this seminar, with its relevant subtopics:

• Physiological and Pharmacokinetic Principles
• Drug Dissolution Testing
• Linking Dissolution Results to Plasma Drug Levels.

Personnel who work in various levels of the areas of Pharmaceutical Development, setting up analytical methods (pharmacopeial, regulatory or in-house developed), R & D (both analytical and formulation), Project Management, Quality Control, Quality Assurance, and Regulatory Affairs will benefit enormously from this learning.

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.

 

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Learn any professional courses for $10 only

Want to enhance your regulatory compliance career by learning a new course? All that it costs is $10. Yes, GlobalCompliancePanel, a provider of professional trainings, is offering hundreds of high value regulatory compliance courses for a mere $10 each.

Regulatory compliance learning, that vital ingredient needed for professionals in any area of regulatory compliance, is a put off, because many professionals consider it expensive. But not anymore. GlobalCompliancePanel makes it possible to scale up in one’s career. What used to cost $265 is now available for $ 10, at about the price of a T-shirt. See the math: It is a saving of about 95%.

Myriad number of courses

Regulatory compliance, as we all know, is a really vast area of knowledge. With the FDA framing innumerable laws and regulations on every area that it regulates, it is imperative for regulatory professional to show compliance with the regulations. They are doomed if they fail. GlobalCompliancePanel brings hundreds of courses in all the areas of regulatory compliance to help professionals understand how to meet these stringent standards.

Want to explore what expectations the FDA has of the drug development process? Want to understand the nitty gritty of drug development and how to meet the FDA’s stringent requirements as far as IND and NDA requirements, or nonclinical or the human clinical studies required for it? Then, take a look at how GlobalCompliancePanel can help you achieve this, for just $10.

Are you working in an industry in which you are required to carry out Root Cause Analysis, but are having problems with it? Understand the fundamentals of Root Cause Analysis and get to know how to determine what caused the problem, why it happened, and what to do about it to reduce its likeliness of occurrence, with this course from GlobalCompliancePanel.

Have you understood how to get HACCP validation done for your facility? Do you have a problem in grasping its validation and verification? No worry. This recorded webinar from GlobalCompliancePanel will set you on the path to it. At just $10, it will offer you the knowledge you need for understanding how to tackle supplier and other issues and put in place a robust HACCP validation and verification program.

This is just a small sample of the many courses that are on offer for $10 each. Want to explore how many more courses are on offer at this huge discount price? Then, just visit our website to open up the possibility of unlimited learning. All that you need to spend is just $10 to enhance your learning on an area of regulatory compliance.

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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.

 

 

 

 

 

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.