The Interplay of the Americans With Disabilities Act, the Family and Medical Leave Act, and Workers’ Compensation

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The Americans with Disabilities Act (ADA), the Family and Medical Leave Act (FMLA), and Workers Compensation laws-the three core US laws concerning employment-are intricately related to each other. Their relationship with each other is such that it has earned the epithet, the “Bermuda Triangle of employment law”.

Considering that employers who come under these laws can be hauled up legally if they fail to comply with these laws; it is absolutely essential for them to understand the nitty-gritty of each of these laws and the way each relates to the other. The penalties that attach to noncompliance are significant. So, employers are morally and legally bound to implement the ADA, FMLA and Workers Compensation laws at their organizations to ensure that the employees receive the benefits and protections these laws provide.

To do so, everyone in the organization concerned with the application of these laws, such as senior leadership, human resources professionals, compliance professionals, payroll professionals, and operations professionals, needs to be aware of the meaning, purpose and detail of these laws.

It is to familiarize them with not just the letter, but also the spirit of these laws that GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, is organizing a six-hour learning session on the topic, “The Interplay of the Americans With Disabilities Act, the Family and Medical Leave Act, and Workers’ Compensation”, on January 15, 2020.

Diane L. Dee, President of Advantage HR Consulting LLC, will be the expert at this session. Please log on to Globalcompliancepanel to register for this highly pertinent and valuable webinar.

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Each of these laws carries its own unique purposes and background in which it was legislated. At their core, this the purview of each of these laws:

  • The ADA: Aimed at prohibiting discrimination at the workplace
  • The FMLA: This law sets minimum leave standards
  • Workers compensation laws: Set the rules for the ways and extent to which employees who get injured at the workplace need to be compensated and rehabilitated and for minimizing employer liability.

There is significant overlap when these three laws are to be applied in practice, often in tandem. For example, most unscheduled and scheduled absences related to the illness of an employee or a family member, call for application of each, two or all three of these laws. When these laws are not implemented in the way they are supposed to be, the employers risk facing significant penalties and may have to take remedial actions that could include reinstatement, backpays, retroactive benefits, and damages of various kinds.

Participants of this webinar will gain a clear understanding of each of these laws individually, and more importantly, the way they interact with each other. They will learn how to integrate these aspects of these laws into company policies. The expert will also show how employers should make these policies known to the employees.

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About the speaker: Diane brings over 25 years of experience in the Human Resources arena. She has done HR consulting and administration in corporate, government, consulting and pro bono environments. Her organization provides comprehensive, cost-effective Human Resources solutions for small to mid-sized firms in the greater Chicagoland area. Additionally, Diane conducts webinars on a wide-variety of HR topics for training firms across the country.

 

Evolution of the Quality Management System

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An efficient and effective Quality Management System is the cornerstone for organizations in the regulated industries. Such a QMS signals to the regulatory authorities such as the FDA and others, that there are no lacunae in the completeness, accuracy, and consistency of an organization’s QMS.

It is not to satisfy the regulatory bodies alone that a robust QMS is necessary: it also gives the organization’s personnel the ability to meet quality requirements with consistency and accuracy. Accuracy of outcomes and quality of work are the results of such an assurance.

It is to help organizations in the regulated industries understand and get their QMS right, in the prescribed manner, that GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, is organizing a long, six-hour webinar, on Jan 21, 2020.

GlobalCompliancePanel brings Susanne Manz, a well-known and highly accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, as the Director of this web seminar. To register for this highly valuable learning, please log on to GlobalCompliancePanel

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The regulatory guidelines state that the organization should “…establish and maintain a quality system that is appropriate for the specific medical device(s) designed and manufactured”. This makes it imperative for organizations to understand the exact requirements relevant to them and tailor them to their precise needs.

The consequences of having an inefficient QMS are obvious:

  • It can lead to serious compliance and quality issues, inviting 483 observations, Warning Letters, and even consent decrees
  • It can lead to inconsistent or poor product quality, which could result in non-conformances, complaints, and even recalls
  • The confusion and inconsistency it generates could lead to duplication of work and corrective and preventive actions, all of which can drastically increase the cost of quality

It goes without saying that utterly squandered time and money, and missed opportunities are the fruit of all this.

This marathon session will help participants understand the gravity of these issues and teach them how to avoid getting into these troubles, which can eventually destroy the business.

At this session, Susanne will explain the fundamentals of a sound QMS. She will show how to put in place an efficient and effective QMS with which the organization can meet its compliance objectives and improve its product quality, which brings in higher customer satisfaction and vastly enhanced business outcomes.

Core aspects of how to establish and maintain a QMS will be explained. These include the Basic Requirements, Management Responsibility, Quality Audit, Personnel, QMS structure, Quality Policy, Quality Manual and Standard Operating Procedures, Work Instructions, Forms, etc.

Participants will gain the following learning objectives at this session:

  • Overview of the Regulations
  • Essentials of an effective QMS
  • Essentials of an efficient QMS
  • Lessons learned and common Mistakes
  • Maturity modeling
  • Improvement tools
  • Best practices
  • Preparing for an FDA inspection

This webinar has the following agenda:

  • Regulatory Expectations
  • Lessons Learned from 483s and Warning Letters
  • Common Problems, Mistakes, and Warning Signs
  • How to Structure your QMS
  • Quality Policy and Manual Requirements
  • QMS Structure, Hierarchy, and Documents
  • Roles and Responsibilities
  • Key capabilities
  • Best Practices
  • Vision, Strategy, and Planning

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About the expert: Black Belt, Master Black Belt, Regulatory Affairs Certification (RAC) and Certified Quality Auditor (CQA) Susanne Manz brings an extensive background in quality and compliance for medical devices, which spans all areas from new product development, to operations, to post-market activities. Her consulting business provides services to help medical device companies achieve world-class quality and compliance.

 

Transition from Peer to Supervisor

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A promotion is certainly something that every employee looks forward to. In most cases, it is a just reward for all the hard work, initiative, dedication and motivation an employee exhibits at work. Yet, most employees what are promoted fail to reckon with a very problematic situation that a promotion brings: having to work with the very colleagues the employee superseded and got promoted.

This can be quite an issue, because, after all, it is human nature to be insecure, envious and even cantankerous about a peer’s progress, even if it was well-deserved. Having to deal with such colleagues requires tact, amiability, understanding and openness.

Tonia Morris, Founder of Simply HR, LLC a consultant and management firm, will show what qualities to cultivate and demonstrate in such situations at a four-hour webinar that is being organized on January 10, 2020 by GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance.

At this webinar, which is of immense value to Managers, Supervisors, Leaders, Human Resource Professionals, and Shift leaders or Team; Tonia will get down to explaining ways by which supervisors can lead from the front without getting into conflict with their colleagues, especially those whose position they would have taken, or those who they would have outperformed.

Please visit Globalcompliancepanel to register for this valuable learning.

 

This webinar will offer newly promoted employees the tools and techniques for dealing with their colleagues. It is vital for them to have this knowledge because lack of it can result in frictions at work. As conflict deepens, there are chances of many employees quitting the organization and looking for better options. The learning gained at this webinar will help the participants foster better employee engagement, a core factor in retaining talent and increasing productivity.

The result of this learning is that the newly promoted supervisor will be better equipped to handle discordance at work. Tonia will show how to motivate direct reportees and handle conflict while remaining legally compliant all the time. The skills learnt at this webinar can be applied straightaway at work.

This webinar will have the following agenda:

  • Setting Yourself up for Success
  • Developing Legal Awareness
  • Understanding Communication Styles
  • How to Build Trust
  • Motivating your Team to achieve results
  • Delegating Work to Your Team
  • Managing Employee Performance
  • Time Management
  • How to deal with uncomfortable situations

 

About the speaker:

Tonia Morris, who calls herself “your Generational Connector”, owns her speaking and training company. An accomplished speaker, Tonia offers leaders training solutions that cultivate a generationally-inclusive work place.

She has partnered with organizations such as Chick-fil-A, Oracle, Spelman and Kennesaw University to name a few, to bring training solutions for engaging Millennials in the workplace, working with leaders to transform their cultures by attracting, developing and retaining a workforce that is generationally inclusive.

With more than 20+ years of progressive HR experience, Tonia provides keynote speeches, lunch-and-learns, and workshops for organizations and associations across the Southeast.

 

 

What are the FDA’s Process Validation requirements?

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Process Validation (PV), according to the FDA, is collecting and assessing data right from the design stage till the production stage. PV is set out for all the stages of production for a product in the FDA-regulated industries. The core purpose of PV is to establish scientific proof that any process being employed has the capability of delivering quality products consistently.

The FDA’s process validation requirements are set out in its general principles of Process Validation. Starting from 1987, the FDA has been issuing guidelines at intervals to state, improve and strengthen the general principles of Process Validation. In almost a quarter century of the first guideline, the revision of January 2011 came into being. This guideline is considered a landmark and a guide for PV professionals since it reworked extensively and expanded the general principles on process validation. It is the current guideline from the FDA on Process Validation requirements.

These are what the FDA’s 2011 guideline on general principles on Process Validation propagate:

  • Incorporation of the principles of sound science
  • Taking steps to assess and mitigate risk
  • Bringing about improvements in every stage of the process
  • Adapting the science-based principles of contemporary manufacturing
  • Fostering and encouraging innovation

The centrality of control to process validation

Process validation is tied to the product lifecycle approach by the FDA general principles on process validation of 2011. The central purpose of process validation is to ensure that the process is in a state of control at all stages of production.

The following points illustrate the reason for which the FDA expects its PV requirements to be met:

  • Being a process that is ongoing and continuous, PV begins at the earliest stages of production and goes on till the product’s lifecycle is completed
  • Those in charge of commercial production should have deep and intimate knowledge of the workings of PV principles
  • Only this knowledge helps PV professional locate the sources of variability and address them
  • Only PV into which risk management is built frees errors from the product

The three stages of PV

The FDA stipulates three layers or stages on which its general principles of Process Validation are built:

  • Process design: The stage in which the knowledge gained helps the commercial process define the process development activities
  • Process qualification: The stage where PV guarantees that the process design has the capability for being reproduced at industrial level
  • Continued Process Validation: The most important stage PV in that this is where the element of control into the routine production process is introduced and built; Continued Process Validation takes under its ambit all activities such as continuous verification, maintenance, and process improvement. Information is collected and monitored during commercialization to assess the Continued Process Validation stage.

Project management critical tasks within each project phase

Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military. 

It is not possible to present a complete treatment of project management in the span of 6-hours.  It is however, possible to focus in on those most important aspects of project management that are critical to the success of any project.  Without basic tools, it is not possible to effectively manage a project to the pre-determined end-date without turmoil and chaos.

We have distilled the key aspects of project management into three two-hour virtual seminar segments that will logically move participants from the beginning of the project management process to the end – from initiating the project to closing the project.

Project-Management

The seminar is designed to build a working understanding of the subject and for a quick start-up for those unanticipated project management assignments.

Who will be benefit by this:

  • Any member of a Cross Functional Project Team that has the Potential Opportunity to Lead that Project
  • Engineers
  • Marketing Associates
  • Product Managers
  • Program Managers
  • Contract Managers
  • Project Managers
  • Research & Development Associates, Managers, and Directors
  • Design Engineers
  • Manufacturing Managers

About the Inructor:

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, manufacturing, training, and technical documentation consulting firm – celebrating its twentieth year in business in 2017. Charles has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc.. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military.

The FDA Drug Development Process

This webinar provides an overview of the FDA’s Drug Development Process. This webinar also includes the major FDA regulations involved in the Drug Development Process – the GLP, GMP and GCP regulations.

This webinar is ideal for those who are new to the Drug Development process and those experienced researchers that need an update on FDA requirements.

Why should you Attend:This webinar is a must for those who have to have an understanding of FDA’s Drug Development Process.

Areas Covered in the Session:

  • Overview of FDA’s Drug Development Process
  • Nonclinical studies required
  • Human clinical studies required
  • IND requirements
  • NDA requirements

Who Will Benefit:

  • Regulatory Affairs Personnel
  • Quality Personnel
  • Research Personnel
  • Clinical Personnel
  • Project Managers
  • Legal Personnel
  • Those personnel that require a general understanding of the FDA’s Drug Development Process
Speaker Profile

Albert A. Ghignone MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical. He has been responsible for regulatory submissions, registrations, FDA liaison, clinical studies, compliance activities and FDA training. He also has expertise in the assessment of product and facilities for due diligence relative to FDA requirements. He lectures throughout the world on numerous FDA related matters. He is a consultant to FDA and trains FDA Field Force (those who conduct FDA inspections) on GCP, GLP and GMP). In addition to training FDA personnel Mr. Ghignone also consults/trains for Drug, Biologic and Medical Device companies, US Army HIV Research Group, NIH AIDS Group, US Army Surgical Research Group and the Naval Medical Research Group. He is a member of the Regulatory Affairs Professionals Society which elected him the 1984 Professional of the Year. He has served the society as Vice President, President and Chairman of the Board of Directors.

In recent years he has filed numerous FDA drug, biologic and medical device submissions for product approval. In addition he has been involved in two of the largest clinical trials conducted, the 8,000 patient clinical trial in Africa and the 16,000 patient clinical trial in Thailand.

Applied Statistics for FDA Process Validation

Course “Applied Statistics for FDA Process Validation” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, “”…the collection and evaluation of data, from the process design stage through commercial production..” The guidance further delineates the ‘process design stage through commercial production’ into three distinct stages of the product lifecycle:

Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.

Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

Stage 3: Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

The first stage of process validation is process design. The Process Validation guidance document states, “A successful validation program depends on information and knowledge from product and process development. This knowledge and understanding is the basis for establishing an approach to control of a manufacturing process that results in products with desired quality attributes:

Manufactures should:

  • Understand the sources of variation
  • Detect the presence and degree of variation
  • Understand the impact of variation on the process and ultimately on product attributes
  • Control the variation in a manner commensurate with the risk it represents to the process and product.”

The second stage of process validation is process qualification. Although stage 2 has two elements, this course will focus on recommendations for the second element, PPQ. PPQ “combines the actual facility, utilities, equipment (each now qualified), and the trained personnel with the commercial manufacturing process, control procedures, and components to produce commercial batches.” Additionally, the process validation guidance document that “Each manufacturer should judge whether it has gained sufficient understanding to provide a high degree of assurance in its manufacturing process to justify commercial distribution of the product. Focusing exclusively on qualification efforts without understanding the manufacturing process and associated variations may not lead to adequate assurance of quality.”

The third stage of process validation is continued process verification. The process validation guidance document defines the need for this stage: “After establishing and confirming the process, manufacturers must maintain the process in a state of control over the life of the process, even as materials, equipment, production environment, personnel, and manufacturing procedures change.” Manufacturers should use ongoing programs to collect and analyze product and process data to evaluate the state of control of the process. These programs may identify process or product problems or opportunities for process improvements that can be evaluated and implemented through some of the activities described in Stages 1 and 2.”

This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance. It begins with a primer on statistics, focusing on methods that will be applied in each remaining chapter. Next, it teaches the application of statistics for setting specifications and assessing measurement systems (assays), two foundational requirements for process validation. Lastly, the course applies statistic through the three stages of process validation defined by requirements in the process validation regulatory guidance documents. Methods taught through all three stages are recommended by regulatory guidance documents; references to the specific citations in the guidance documents are provided.

Why you should attend:

The Food and Drug Administration (FDA) provided a guidance for industry in 2011 that has established a framework for process validation in the pharmaceutical industry. This guidance, titled “Process Validation: General Principles and Practices” consists of a three-stage process. The three stages are 1) Process Design, 2) Process Qualification, and 3) Continued Process Verification.

This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process development and validation program consistent with the FDA guidance. This course teaches the application of statistics for setting specifications, assessing measurement systems (assays), using design of experiments (DOE), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the three-stage product cycle framework defined by requirements in the process validation regulatory guidance documents.

Although established for the pharmaceutical industry, it also provides a useful framework for other industries.

Analyses in this course use the point-and-click interface of JMP software by SAS.

Areas Covered in the Session

  • apply statistics to set specifications and validate measurement systems (assays)
  • develop appropriate sample plans based on confidence and power
  • implement suitable statistical methods into a process validation program for each of the three stages
  • Stage 1, Process Design: utilize risk management tools to identify and prioritize potential critical process parameters; and define critical process parameters and operating spaces for the commercial manufacturing process using design of experiments (DOE)
  • Stage 2, Process Qualification: assess scale effects while incorporating large (pilot and/or commercial) scale data; develop process performance qualification (PPQ) acceptance criteria by characterizing intra and inter-batch variability using process design data and batch homogeneity studies; and develop an appropriate sampling plan for PPQ
  • Stage 3, Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable.

Who Will Benefit:

This seminar is designed for pharmaceutical and biopharmaceutical professionals who are involved with product and/or process design, validation, or manufacturing/control.

  • Process Scientist/Engineer
  • Design Engineer
  • Product Development Engineer
  • Regulatory/Compliance Professional
  • Design Controls Engineer
  • Six Sigma Green Belt
  • Six Sigma Black Belt
  • Continuous Improvement Manager

Day 1 Schedule

Lecture 1: Introduction to Statistics for Process Validation

  • principles of process validation
  • stages of process validation

Primer on Statistical Analysis

  • basic statistics

Lecture 2: Primer on Statistical Analysis (cont.)

  • statistical intervals and hypothesis testing

Lecture 3: Primer on Statistical Analysis (cont.)

  • statistical intervals and hypothesis testing
  • ANOVA

Lecture 4: Primer on Statistical Analysis (cont.)

  • regression
  • run charts

Day 2 Schedule

Lecture 1: Foundational Requirements for Process Validation

  • setting specifications
  • analytical methodology

Stage 1 – Process Design

  • steps to DOE
  • screening designs

Lecture 2: Stage 1 – Process Design

  • response surface designs
  • establishing a strategy for process qualification

Lecture 3: Stage 2 – Process Qualification

  • introduction
  • incorporation of large-scale data
  • development of PPQ acceptance criteria
  • development of sampling plans

Lecture 4: Stage 3 – Continued Process Verification

  • statistical process control
  • process capability

Heath Rushing

Co-founder and Principal, Adsurgo

Heath Rushing is the cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP. Previously, he was the JMP and Six Sigma training manager at SAS. He led a team of nine technical professionals designing and delivering applied statistics and quality continuing education courses. He created tailored courses, applications, and long-term training plans in quality and statistics across a variety of industries to include biotech, pharmaceutical, medical device, and chemical processing. Mr. Rushing has been an invited speaker on applicability of statistics for national and international conferences. As a Quality Engineer at Amgen, he championed statistical principles in every business unit. He designed and delivered a DOE course that immediately became the company standard required at multiple sites. Additionally, he developed and implemented numerous innovative statistical methods advancing corporate risk management, process capability, and validation acceptance criteria. He won the top teaching award out of 54 instructors in the Air Force Academy math department where he taught several semesters and sections of operations research and statistics. Additionally, he designs and delivers short courses in statistics, data mining, and simulation modeling for SAS.

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