Getting Design of Experiments and Statistical Process Control right for Process Development and Validation

Procedures must be used in the application of DOE and SPC to the development, design and monitoring of manufacturing and testing processes. Why this needs to be done is because the FDA has, in a recent guidance document on Process Validation, assigned the responsibility for reviewing and interpreting DOE and SPC studies to the Quality Unit.

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Going about doing this work requires a practical orientation. It calls for an approach with case studies and examples. A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will provide just this and fulfill this requirement.

Dr. Steven Kuwahara, Founder and Principal, GXP BioTechnology LLC, will be the Director at this two-day session. To enroll for this valuable session, please register by logging on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900701SEMINAR. 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 interactive session

Dr. Kuwahara will offer theoretical information introduced only when necessary to understand an experiment. A highly interactive and practical session; this seminar offers examples from real processes and testing procedures and present the participants with examples that will be directly applicable to their work.

For any pharmaceutical worker who performs, supervises or reviews manufacturing or testing processes, an understanding of the relationships among the process parameters and the ability to monitor the performance of processes and test methods are necessary. This is all the truer of the worker in Quality Control and Quality Assurance in view of the recent FDA guidance document on Process Validation.

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This work, however, is done by the development, manufacturing, or quality systems worker. So, synchrony between these two levels of employees is needed. This course will equip these two levels of employees with the knowledge of how to design the systems and studies, and interpret the results generated.

Extracting Information from Geochemical Data

Going beyond just asking the laboratory for geochemical extracting information of a gold test by sampling every meter of the drill core of a trench and using multielement analysis is an approach strongly recommended by most mining specialists. There exist other methods of geochemical data analysis techniques and obtaining geochemical extracting information, but these are largely ignored by the industry.

Making sense of the geochemical extracting information

How to make sense of the geochemical extracting information is the core of a webinar that is being organized by GlobalCompliancePanel, a well-known provider of professional trainings for all the areas of regulatory compliance. The speaker, Ricardo Valls, is a professional geologist with thirty years in the mining industry. With extensive geological, geochemical, and mining experience, managerial skills, research techniques, and training; he has carried out various projects globally.

To know more about how to gain knowledge of geochemical extracting information, just visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900826SEMINAR to register.

An understanding of all types of analyses

Richard will give participants an understanding of all the types of analyses that can be requested to help them in their exploration goal –that of finding the new ore body. He will help mining professionals who need to make important decisions on where to drill or how to manage their exploration budget. The speaker will also offer an understanding of how to extract all the important information of data, including the use of compositional data analysis.

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In this webinar, which will be highly educative for a number of professionals in mining, such as Senior Geologists, Geochemists, Exploration personnel, Laboratory personnel, Managers, graduate students, postgraduate students and QA&QC personal; Richard will cover the following areas:

  • How to determine the type of sampling
  • How to determine the type of assays
  • General processing of the data
  • Compositional Data Analysis
  • Representing the results.

Comprehensive risk management is a must for medical device software

Diligent, complete and correct implementation of risk management of software used in medical devices that takes into consideration the gaps and corrects them from the start of product development is absolutely imperative. This is because of two critical reasons:

  1. Gaps, incorrect or incomplete implementation can retard or delay or make the certification/approval of medical products impossible;
  2. Since most activities are closely linked to the development lifecycle; almost none of it can be retrospectively performed. This renders all activities performed till the identification of gaps useless and redundant; making it necessary to start from the beginning, no matter at what stage an anomaly is discovered.

Embedding software risk management into the bigger scope of overall risk management is the way forward if these fiascos have to be avoided.

Risk Management Shows Identifying, Evaluating And Treating Risks

Learn the ways of doing it right from start till finish

The proper ways of how to take all the necessary steps for designing, implementing and testing critical medical device software in a regulatory compliant environment will be the learning a two-day, live seminar being organized by GlobalCompliancePanel, a very respected provider of professional trainings for the regulatory compliance areas will impart.

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Markus Weber, Principal Consultant with System Safety, Inc., who specializes in safety engineering and risk management for critical medical devices, will be the course Director. To participate in this very important seminar, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900683SEMINAR.

In line with globally applicable standard requirements

International consensus, reflected in globally applicable standard requirements such as ISO14971 and IEC62304, has led to risk management being a mandatory component of almost any activity in the medical device industry. This course will explain these requirements.

Given that software risk management has to be embedded into the bigger scope of overall risk management; Markus will introduce all the steps necessary to design, implement and test critical medical device software in a regulatory compliant environment while adhering to the principles of risk management. In addition, he will also address the system level risk management and the resulting interfaces to software.

Understanding safety assurance cases

The ‘Safety Case’ or ‘Assurance Case’ document is a well-established method to collect all safety related information together in one place to comprehensively summarize all risk related activities and to demonstrate the safe properties of a device. Currently only required for FDA infusion pump submissions; this documentation will most likely become mandatory for all devices. This course will introduce the basic concepts and content of safety assurance cases and will illustrate their usefulness for internal and external review of safety related information.

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This seminar will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. It will address the system level issues of risk management as well as the increasingly important software related issues of critical systems. The concept of an assurance case will be introduced to make the combined effort towards designing, implementing and verifying a safe device transparent. The outcome of this learning is that it will help to comply with regulatory requirements with minimized overhead and resource burden.

Comprehensive risk management is a must for medical device software

Diligent, complete and correct implementation of risk management of software used in medical devices that takes into consideration the gaps and corrects them from the start of product development is absolutely imperative. This is because of two critical reasons:

  1. Gaps, incorrect or incomplete implementation can retard or delay or make the certification/approval of medical products impossible;
  2. Since most activities are closely linked to the development lifecycle; almost none of it can be retrospectively performed. This renders all activities performed till the identification of gaps useless and redundant; making it necessary to start from the beginning, no matter at what stage an anomaly is discovered.

Embedding software risk management into the bigger scope of overall risk management is the way forward if these fiascos have to be avoided.

Learn the ways of doing it right from start till finish

The proper ways of how to take all the necessary steps for designing, implementing and testing critical medical device software in a regulatory compliant environment will be the learning a two-day, live seminar being organized by GlobalCompliancePanel, a very respected provider of professional trainings for the regulatory compliance areas.

Markus Weber, Principal Consultant with System Safety, Inc., who specializes in safety engineering and risk management for critical medical devices, will be the course Director. To participate in this very important seminar, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900681SEMINAR?risk-management-medical-devices-Boston-MA

In line with globally applicable standard requirements

International consensus, reflected in globally applicable standard requirements such as ISO14971 and IEC62304, has led to risk management being a mandatory component of almost any activity in the medical device industry. This course will explain these requirements.

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Given that software risk management has to be embedded into the bigger scope of overall risk management; Markus will introduce all the steps necessary to design, implement and test critical medical device software in a regulatory compliant environment while adhering to the principles of risk management. In addition, he will also address the system level risk management and the resulting interfaces to software.

Understanding safety assurance cases                       

The ‘Safety Case’ or ‘Assurance Case’ document is a well-established method to collect all safety related information together in one place to comprehensively summarize all risk related activities and to demonstrate the safe properties of a device. Currently only required for FDA infusion pump submissions; this documentation will most likely become mandatory for all devices. This course will introduce the basic concepts and content of safety assurance cases and will illustrate their usefulness for internal and external review of safety related information.

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This seminar will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. It will address the system level issues of risk management as well as the increasingly important software related issues of critical systems. The concept of an assurance case will be introduced to make the combined effort towards designing, implementing and verifying a safe device transparent. The outcome of this learning is that it will help to comply with regulatory requirements with minimized overhead and resource burden.

 

 

Understanding supplier management for medical devices

The problem with a supplier management program lies in the fact that the FDA audits suppliers only for finished devices. Because of this, manufacturers need to have a high degree of control over them. So, where is the problem? It lies in the FDA’s interpretation of these expectations. This keeps changing from time to time. Over the past five years, these expectations have changed considerably. Manufacturers whose devices have been around for more than five years need to thus make substantial changes into their cGMPs, hence the emphasis on the ‘c’, meaning “current”.

A seminar from the guru of supplier management

The underlying principles of supplier management will be the basis for a two-day seminar that is being organized by GlobalCompliancePanel, a reputable provider of professional trainings for the areas of regulatory compliance. The Director of this course, Betty Lane, who is the founder and President of Be Quality Associates, LLC, a consulting company that helps small and medium sized medical device and diagnostic companies implement and improve their Quality Systems, will be the Director of this seminar.

To enroll for this very valuable learning session, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900595SEMINAR?medical-device-manufacturers-Switzerland. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

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Analogous to the FDA’s thinking, European Notified Bodies also periodically update their expectations. Suppliers are now expected to remain current with a guidance document published by the Notified Body Operations Group (NBOG). This seminar will explore the details of the NBOG supplier guidance document and a GHTF (Global Harmonization Task Force) guidance that describes the current FDA expectation on supplier management by expanding on them to cover other issues and techniques important in effective implementation.

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Tools, templates and methods of supplier management

Betty will familiarize participants with the nitty gritty of supplier management by building upon it with the tools, templates, and methods needed for implementing an effective and efficient supplier management program. These tools consist of practical exercises which the Director will get the participants to perform.

She will also use FDA Warning Letters to illustrate the points and help the participants learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers’ location, supplier auditing techniques, and supplier issues in management review. These practical steps are aimed at fortifying and reinforcing their understanding of the topic. It will also offer the kind of interactivity with which the participants can understand the concepts threadbare.

The insight the Director will be offering into the area of supplier management will be the highlight of this seminar. This has been accumulated over years and years of experience that the Director has gained in the area of supplier management in medical devices. The Director will detail and examine the concept of risk from the perspective of both the supplier and the regulatory bodies with depth and clarity. She will also review requirements and expectations of the FDA and European Notified Bodies for supplier management, and then show how to incorporate these into the participants’ own supplier management process.

Getting overtime pay calculation wrong can be damaging for the employer

A thorough grasp of the subtleties of the Fair Labor Standards Act (FLSA) continues to elude many employers, even though this Act has been around for a long time. The frequent changes that keep happening to the many regulations of the FLSA from time to time are one of the major reasons for this. These changes have employers, employees and attorneys scrambling for the meaning, interpretation and application of the new regulations, resulting in a huge load of extremely expensive FLSA lawsuits under this legislation.

Most of these legal disputes arise because attorneys make impermissible deductions from wages. They don’t count all the hours an employee has worked in determining overtime due, or they get their calculations plain wrong.  An idea of the magnitude of the effects of this misunderstanding of the provisions of the FLSA by employers can be had from the fact that The Department of Labor (DoL), which is already operating on a budget of $311 billion; requested an additional $104.5 billion for its 2015 budget for discretionary and mandatory programs. All these point to a new vigor and zest in this department in cracking down on false calculations and other improprieties.

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Learn the nuances of overtime pay

In order to clear the misunderstandings anyone may have about the various elements of this law; GlobalCompliancePanel, a well-known provider of professional trainings for the areas of regulatory compliance, will be organizing a two-day seminar. Susan Fahey Desmond, a principal with Jackson Lewis PC, who has been representing management in all areas of labor and employment law for over 30 years, will be the Director of this seminar. To enroll for this highly valuable learning session, please log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900679SEMINAR?calculating-overtime-correctly-SFO-CA.

At this seminar, Susan will go through all of the nuances of the FLSA and will cover the most frequent mistakes employers make repeatedly. She will explain the employer/employee relationship under the FLSA in detail, and will offer a description of areas such as the exemptions and what time is compensable. Another important learning of this seminar is about ways by which employers can decrease their overtime liability.

Susan will cover the following areas at this seminar:

  • Understanding the employer/employee relationship under the FLSA
  • Analysis of independent contractor v. employee
  • Volunteers and trainees
  • Exemptions – managerial, administrative, professional, outside sales, specific industry exemptions, the Motor Carrier Act
  • What is Working Time with discussion of the Portal to Portal Act
  • New Requirements for Breastfeeding Mothers
  • Calculating Overtime Correctly – determining the workweek and calculations.
  • Using approved ways to reduce overtime liability – fluctuating workweek, Belo Plans, Union Employee Plans, compensatory time
  • Minimum Wage Requirements and handling of deductions like garnishments, employee theft, company equipment, etc.
  • Child Labor laws – when they can work, what they can do, what breaks are required
  • Recordkeeping Requirements

Verification vs validation is a key understanding for regulatory professionals

For regulatory professionals, aspects of verification and validation, such as how to get verification and validation right, and an understanding of the ways in which verification and validation diverge from each other and converge, make up very important learning. The key point is that verification and validation should be risk based and be built keeping in mind the extant regulatory expectations.

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Building a verification and validation process that sufficiently uses targeted and documented risk based verification and validation test case elements or scripts is the foundation to this. All these have to be reviewed against ISO 14971 and ICH Q 9 hazard analysis and product risk management.

Getting their V & V right involves gaining and exercising proper knowledge of these areas on the part of professionals working in regulatory environments. This learning is what a two-day seminar by GlobalCompliancePanel, a very well-known provider of professional trainings for all the areas of regulatory compliance, will impart.

V & V against the regulatory process

The Director of this seminar, John E Lincoln, a senior Consultant for Medical device and Regulatory Affairs, will explain the rationale behind verification and validation and clear all the ambiguities relating to this activity.

He will help participants to understand the following:

  • Evaluating different field-tested, U.S. FDA-reviewed V&V protocols
  • Ways by which to employ equipment/process Requirements Specs/DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500. John E Lincoln will help participants how to do all these against a background of limited company resources
  • Reviewing a matrix that simplifies “as-product”, “in-product”, process and equipment and related matters
  • Software VT&V to ensure that key FDA requirements are not overlooked

To enroll for this course, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900645SEMINAR?verification-vs-validation-qms-Las-Vegas.

The Director will also offer hands-on understanding of Quality Management Systems and 21 CFR Part 11. This seminar will help participants:

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  • Understand Verification and Validation, differences and how they work together;
  • Know how to document a “risk-based” rationale, and use it in a resource-constrained environment;
  • Determine key “milestones” and “tasks” in a project;
  • Locate and document key subject “inputs”;
  • Compile “generic” Master and Individual Validation Plans;
  • Learn the key element of a Product V&V File/Protocol;
  • Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols;
  • Get a grasp of basic Test Case construction;
  • Understand sample sizes and their justification;
  • Learn the key elements of Software V&V expected by the FDA and how to document;
  • Deal with hardware and software vendors, sales and marketing
  • Consider a field-tested software V&V documentation “model”;
  • See how to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR Part 11.