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Design of Experiments (DoE) for Process Development and Validation

Design of Experiments (DoE) is a very important process development and validation component in several kinds of industries. DoE for process development and validation involves carrying out a number of tests recurrently and steadily over a period of time. Its responses are then observed.

DoE is important for process development and validation as it offers an understanding of the predictability and reproducibility of an experiment. Fundamentally, Design of Experiments for process development and validation seeks to rule out fluke or chance in the methods needed for bringing about control for a product.

DoE in medical devices

In the area of medical devices, guidelines for Design of Experiments for process development and validation are set out in the Global Harmonization Task Force (GHTF) Process Validation Guidance for Medical Device Manufacturers. This document offers guidance in the area of Design of Experiments for process development and validation by suggesting the exact areas in which design of experiments should be applied during Process Validation.

The GHTF guidance also suggests the use of both screening and response surface designs during Operational Qualification. It further requires Design of Experiments for process development and validation to be used during various phases of design controls. These include:

o  Design and development planning

o  Design verification

o  Design validation

o  Design transfer

o  Design changes.

Get a full understanding of Design of Experiments for process development and validation

The ways of approaching Design of Experiments for process development and validation will be topic of a two-day seminar that is being organized by GlobalCompliancePanel, a highly respected provider of professional trainings for the areas of regulatory compliance.

Jim Wisnowski, who is the cofounder of Adsurgo LLC and co-author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP, will be the Director at this seminar. In order to gain a full understanding of the principles and application of Design of Experiments for process development and validation; please register for this seminar by visiting Design of Experiments (DoE) for Process Development and 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.

All about Design of Experiments for process development and validation

This seminar will offer total and all-round understanding of all the aspects of Design of Experiments for process development and validation.

Process development studies need to be completed before a process control plan is developed as part of an overall risk management strategy. These process development studies help gain knowledge and understanding about the impact of variation in process parameters on the variation in the product quality characteristics of the product.

An explanation of the methods used

The methodology of Design of Experiments for process development and validation offers a means for identifying process parameters, which impact product quality (critical process parameters) and determine the functional relationship that links the process parameters to those critical quality attributes.

Design of Experiments for process development and validation uses screening designs such as 2k factorial and D-optimal designs to determine critical process parameters. Design of Experiments for process development and validation use response surface designs, such as Central Composite Designs (CCDs) and I-optimal designs for fashioning the functional relationship between those critical process parameters and the critical quality attributes.

A primer on statistical analysis

This seminar on Design of Experiments for process development and validation will present a primer on statistical analysis, during which it will focus on the methods required for analysis of designed experiments. Jim will then move on to the steps to a proper DoE, during the process of which he will demonstrate the nature and uses of important risk management tools such as Ishikawa and FMEA, which can be used pre and post DOE studies.

The Director will also teach how to generate and analyze multiple screening and response surface designs, and why and how each are used. After teaching participants how to present the results, Jim will explain how to update the risk management tools using the results of the studies.

This session on Design of Experiments for process development and validation will cover the following areas:

o  Identify critical quality attributes (CQAs) that will be used as responses in your designs

o  Utilize risk management tools to identify and prioritize potential critical process parameters

o  Identify critical process parameters and develop a functional relationship between those process parameters and your critical-to-quality attributes (CQAs) using both screening and response surface designs

o  Be able to design and analyze screening designs including a factorial, fractional factorial, and D-optimal design

o  Understand the need for adding center points to a design

o  Be able to design and analyze response surface designs including central composite designs (CCDs), Box-Behnken designs, and I-optimal designs

o  Present results of DOE studies

o  Use systematic understanding from DOE studies to update the control plan that is part of the overall risk management plan.

Adherence to GMP is absolutely essential for Quality Control and Contract Laboratories

It is absolutely essential for contract laboratories to maintain the required standards of Quality Control because of the risk their process involves: After testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check.

This fact is the primary reason for which regulatory agencies such as the FDA, EMA and many others place the highest emphasis and priority on inspections of QC laboratories. This is also one of the main reasons for which a huge number of QC related 483's and Warning Letters get issued to companies that have problems with their implementation, despite the existence of cGMP regulations for a long time.

Helping to understand and imbibe GMP

A complete understanding of GMP for Quality Control and contact laboratories will be offered at a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be organizing. Dr. Ludwig Huber, Chief Advisor - Global FDA compliance at Agilent Technologies, will be the Director at this seminar.

To gain the benefit of this learning, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900698SEMINAR. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

The regulatory background and guidelines

At this highly interactive two-day seminar, Dr. Huber will offer to participants the regulatory background and guidelines needed for all critical areas of GMP compliance. He will update them with the latest requirements of this compliance document, which will help them understand and implement these.

As a result of the learning gained at this two-day course, participants will be able to:

o   Learn about the regulatory background and GMP requirements for quality control and contract laboratories

o   Understand and be able to explain their company's quality plan or laboratory compliance master plan

o   Understand the difference between GMP and non-GMP laboratories

o   Learn how to develop inspection ready documentation

o   Be able to train others in their organization on GMP requirements

o   Learn how to avoid and/or respond to the FDA inspectional observations and Warning Letters.

A practical session

In addition, the Director will also be providing participants with templates and examples with which they can develop inspection-ready documentation. Another of the highlights of this session is that practical examples and interactive exercises will be sprinkled into and between the presentations, with half of the duration of the seminar being dedicated for practical sessions.

Taking the interactive element a step further, Dr. Huber will arrange participants into small groups for the purpose of discussing case studies and prepare the answers using prepared fill-in templates. Yet another bonus of this session is that after the course, Dr. Huber will make a large variety of tools such as SOPs, validation examples and checklists readily available on a dedicated website so that those who have attended this seminar can use them to easily implement what they have learned from the course. 

A complete understanding of the payroll law

Those who are responsible for payroll or employer tax withholding compliance or have just been hired or promoted into the payroll department would have discovered during their indoctrination just how important this role is to the success of the organization.

Their learning is a continuous process that goes on and on. Employees in this position need to build a solid foundation for handling their company's payroll obligations and complying with federal and state payroll laws. They need to be familiar with how to find the authoritative laws to support their policies and procedures.

Clear and comprehensive learning

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will help participants achieve this. Miles Hutchinson, who is President, Sales Tax Advisors, Inc., and is a CGMA and experienced businessman, who brings over 35 years in the field, will be the Director of this seminar. To gain the benefit of learning from this expert, please register for this seminar by visiting 

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900485SEMINAR.

Equipping participants with the law in all its depth

This organized and thoughtful learning session will help participants accelerate their learning and understand how to handle their role with confidence. Miles will help participants who are concerned about their company's ability to comply with U.S. labor and payroll laws with a formal study of the rules of engagement. This will help ensure that their company pays their employees fairly and handles tax and other withholdings appropriately, as mandated by law.

Miles will show where to find the laws, how to interpret them and how to apply them in the most effective ways. The objective of this learning is to equip its participants with the skill and knowledge needed to master the laws and identify the best practices to keep their organization in compliance and out of court. Implementing this saves them huge sums of money in fines and legal.

A very broad range of topics will be covered at this seminar. These include:

o   Worker classification

o   Employee classification

o   Ways of establishing methods and rates of pay

o   What must be included in the rate of pay

o   Hours that must be compensated as worked time

o   Required benefits

o   De minimus working fringes

o   Withholdings and deductions from pay

o   Voluntary deductions

o   Child support and garnishment orders

o   Payroll reporting

o   Analysis of risks of noncompliance

o   Proper documentation of the policies and procedures and record retention requirements. 

Identifying and managing key risks is the primary purpose of HR auditing

Human resources audit should qualify as the most important of all audits of an organization. This is because HR auditing is directly related to employees. This resource, the organization’s human capital, is the organization’s most important resource. It is through an HR audit that an organization evaluates this resource’s strengths and weaknesses.

HR audits help organizations in a number of ways

HR auditing helps organizations achieve this in many ways. Through HR audits, organizations are able to eliminate human capital risks, which will lead them to core actions such as ascertaining potential and actual problem areas, assessing the effectiveness of current HR management activities, measuring the weaknesses in HR internal control processes, evaluating human capital strategic and compliance related risks, and suggesting corrective action on all these.

Getting the HR auditing right

Getting its HR audit right is the foundation to all these for an organization. The ways by which this can be achieved will be the subject of a two-day seminar that GlobalCompliancePanel, a renowned provider of professional trainings in the regulatory compliance areas, will be organizing. You can register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900675SEMINAR.

 The Director at this seminar, Ronald Adler, who is President of Laurdan associates, Inc., will offer insights, accumulated over four decades in the industry, into HR auditing.

The basis of effective HR auditing lies in asking the right questions

Ronald Adler will emphasize the point that the root to carrying out HR audits effectively is in asking the right questions. The effectiveness of HR audits is measured by how they throw up a structured and systematic series of questions about the areas relating to key compliance, risk management, internal auditing, and human resource management issues in HR, which are the main purpose of these audits.

The role of ERM in HR audits

Another important point that Ronald Adler will highlight at this seminar is the importance of HR audits in considering human capital-related risks and opportunities from an Enterprise Risk Management (ERM) perspective. This means that the HR audit should take a holistic view of human capital risks and align the interrelationships and interactions between HR and other functions relating to management and the organization.

Yet another aspect that will be reviewed is the current use of HR audits. Adler will explain how HR Audits can be used to help the organization reduce risks and grab potential opportunities. All key personnel involved in human capital assessment, such as HR Professionals, CFO's, Internal Auditors, External Auditors, Risk Managers, Compliance Officers, and COO’s, will benefit vastly from this seminar. 

An understanding of HIPAA upcoming changes for 2016

Professionals at various levels of the healthcare industry need to have a grasp of the HIPAA Security/Privacy Rule and the way it relates to their practice or business. A two-day, in person, live seminar being organized by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will offer this very important understanding.

Brian Tuttle, a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), and Certified Business Resilience Auditor (CBRA) , who brings over 15 years’ experience in Health IT and Compliance Consulting, will be the speaker at this seminar. Please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900727SEMINAR to enroll for this highly educative session.

A host of areas relating to HIPAA and changes for 2016

Among the areas that Brian will take up are the changes under the Omnibus Rule and any other applicable updates for HIPAA for 2016. There are an enormous amount of issues and risks that Covered Entities and Business Associates these days. He will also dwell upon other aspects of HIPAA, such as:

o   The history of HIPAA

o   Privacy vs. security,

o   Business Associates,

o   Changes for 2016

o   Audit process

o   Paper-based PHI

o   HIPAA and suing

o   Texting

o   Email

o   Encryption

o   Medical messaging

o   Voice data, and lots more.

Myths vs. realities of HIPAA

Essentially, Brian will explain myths versus reality as it relates to this very enigmatic law, and this clarification will be based on over 1000 risk assessments he has performed during the many years of experience he gained in dealing directly with the Office of Civil Rights HIPAA auditors during his career.

Understanding the risk factors for being sued for wrongful disclosures

He will also speak of real life audits conducted by the Federal government and help participants understand what their highest risks are for being fined. He will discuss the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using State laws to sue for wrongful disclosures.

He will offer an explanation of the multiple litigated cases that he has been a part of involving HIPAA situations. He will also thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information and demonstrate how to limit those risks by simply taking proactive steps and utilizing best practices.

Brian will cover the following areas at this seminar:

o   History of HIPAA

o   HITECH

o   HIPAA Omnibus Rule

o   How to perform a HIPAA Security Risk Assessment

o   What is involved in a Federal audit and how is it conducted

o   Risk factors for a federal audit

o   EHR and HIPAA

o   Business Continuity/Disaster Recovery Planning

o   Business Associates and HIPAA

o   In depth discussions on IT down to the nuts and bolts

o   BYOD

o   Risk factors that can cause an audit (low hanging fruit)

o   New rules which grant states ability to sue citing HIPAA on behalf of a patient

o   New funding measures.