PathWise Brochure

Compliant. Effective. Efficient. In a globally regulated life science industry, PathWise provides proven methodologies in quality and compliance through hands-on and practical solutions that ensure compliant, effective, and efficient quality systems. Through virtual instructor led and on-demand online modules, we help simplify necessary concepts and processes, ensuring a quality system program that conforms to industry and regulatory standards. 866|580|PATH (7284) [email protected]. www.pathwise.com

WE BUILD KNOWLEDGE Our training courses will ensure your team can learn important processes, and understand and apply the principles taught in the classroom environment. 1

WE PROVIDE BENEFITS There are many benefits for your organization when you choose PathWise Training. CONTINUING PathWise is accredited by the International Association for Continuing Education and Training EDUCATION CREDIT (IACET).As a result of this accreditation, PathWise is accredited to issue the IACET CEU. TRAIN NEW HIRE Ensure employees are receiving necessary job OR NEW ROLES training, whether it is for new employee onboarding, or to maintain annual individual training records. INTERACTIVE Our training is more than just a boring PowerPoint. LEARNING We use interactive groups, case studies, discussion, and real world examples, to reinforce concepts being taught. REGULATION & PathWise training covers many important COMPLIANCE regulations and best practices. Ensure employees have the knowledge for a compliant, effective and efficient quality system. ORGANIZATIONAL PathWise will customize your training to illustrate CUSTOMIZATION your organization. Investigate your specific events or revise your own internal documents to maximize the learning experience. 2

TABLE OF CONTENTS INSTRUCTOR LED TRAINING 5 INVESTIGATIONS & CAPA. Investigations and CAPA for Clinical Root Cause Analysis Out of Specification (OOS) Investigations Quality Event Management Complaint Handling Interviewing Skills Effectiveness Checks 9 TECHNICAL WRITING PRINCIPLES Documenting Investigations Writing Standard Operating Procedures Writing Validation Documents Writing for Change Control 13 QUALITY RISK MANAGEMENT For Medical Devices For Pharmaceuticals FMEA Fault Tree Analysis 17 QUALITY CHANGE CONTROL Technical Writing for Change Control 21 QUALITY SYSTEMS & REGULATIONS Quality System Regulation (QSR) Current Good Manufacturing Principles (cGMP) Biologics Good Documentation Practices 24 HUMAN FACTORING OF RECORDS 26 TRAINING 3

TABLE OF CONTENTS ONLINE TRAINING THROUGH EPATH 28 ePath 26 TRAINING FOR COMPLIANCE Quality System Regulation (QSR) Current Good Manufacturing Principles (cGMP) Biologics Good Documentation Practices Combination Products Electronic Records and Signatures Good Clinical Practices (GCP) EU MDR 2017/745 ISO 13485 33 TRAINING FOR QUALITY SYSTEMS Introduction to CAPA Introduction to Technical Writing Introduction to Quality Risk Management Introduction to Quality Change Control Introduction to Human Performance & Factors Inspection Readiness 35 TRAINING FOR PRODUCTIVITY Effective Meeting Management Project Management 37 WEBINARS 42 UNIVERSAL ONLINE TRAINING LICENSE 4

INVESTIGATIONS & CAPA The two day Investigations and CAPA training course helps attendees investigate problems in a quality system. By using an interactive approach to show how to effectively apply risk-based methodology throughout the investigation process, course attendees will be ready when problems occur and ready to prevent future problems. 5

BENEFITS for Investigations & CAPA Reduce the number of repeat investigations. Assess product and process impact by using a risk based approach. Work on your own existing investigations throughout the course, for immediate improvement. Shorten the Investigation Cycle time. 6

INTRODUCTION 7 Identify and distinguish between a correction, corrective action and preventive action. Identify regulatory requirements for Investigations and CAPA EVALUATE Write effective problem statements Conduct Risk Analysis and assess impact Use techniques for interviewing INVESTIGATE Gather specifics Conduct root cause analysis Systematically find cause(s) Establish causal relationships Use quality tools: 5 Whys, Fishbone, IS/IS NOT Identify a process to verify root cause IMPLEMENT Identify a process to implement corrective/preventive actions. Understand project management tools available Write a strong Corrective/Preventive Action Understand effectiveness check and verification requirements Manage and track actions in implementation

Available Modules for Investigation and CAPA CAPA FOR CLINICAL QUALITY EVENT ENVIRONMENTS MANAGEMENT The OOS Investigations course gives an Quality Event Management Training is for overview of industry guidance for Out of organizations that are experiencing a wide Specification (OOS) Investigations. Learn to variety of quality events requiring use a closed loop process to go from investigations. Quality Event Management. problem statement to likely root cause. teaches attendees how to identify, specify, Understand the importance of and prioritize the level of effort required environmental monitoring excursions and based on risk factors. investigation reports. INTERVIEWING COMPLAINT SKILLS HANDLING The Interviewing Skills module shows how Complaint Handling module explores the to organize an interview, ask the right process of complaint handling for FDA and questions, and gather all the needed other world regulatory bodies. It covers information. Learn skills for planning, where complaints come from, how to conducting, and summarizing interviews. determine if something is a complaint, the By performing mock interviews, complaint investigation process, the participants will be able to improve their complaint reply and closing out the interviewing skills. complaint. EFFECTIVENESS OUT OF SPECIFICATIONS CHECKS INVESTIGATIONS (OOS) The Effectiveness Checks training module is The OOS Investigations course gives an designed to teach regulatory expectations overview of industry guidance for Out of and methodologies for more robust Specification (OOS) Investigations. Learn to Effectiveness Checks. Address key issues use a closed loop process to go from organizations struggle with, and clarify key problem statement to likely root cause. topics for those involved in developing or Understand the importance of reviewing Effectiveness Checks. environmental monitoring excursions and investigation reports. 8

TECHNICAL WRITING The PathWise Technical Writing Training suite of courses teaches technical writing skills needed for compliant, effective and efficient written communication. We teach proven principles, tools and techniques, enabling your organization to write clear and concise documents. 9

BENEFITS for Technical Writing Create inspection ready documents. Decrease revisions. Align document expectations across the organization. Utilize your own documents throughout the course, for immediate improvement. 10

TECHNICAL WRITING PRINCIPLES Identify regulatory requirements for technical documents. Correctly construct an organized document. Identify design elements needed for documents. Correctly use concise language. Understand grammar requirements. Differentiate between passive and active language. Identify document opportunity using Microsoft Word tools. 11

Available Modules for Technical Writing TECHNICAL WRITING DOCUMENTING PRINCIPLES INVESTIGATIONS Apply techniques to simplify language and This course enables participants to eliminate clutter. Utilize your own effectively plan the investigation report and organizational documents in class, and document investigations. It clarifies learn the methods and tools to maintain regulatory influence in investigation focus, organize action, and create order. documentation, and helps you to clearly PREREQUISITE COURSE FOR ADDITIONAL communicate the problem, cause(s), and MODULES , 0.8 CEU action(s) needed as determined by the investigation. WRITING STANDARD WRITING FOR OPERATING PROCEDURES CHANGE CONTROL This course discusses the regulatory Writing for Change Control training expectations for Standard Operating provides the model and specifics to create Procedures (SOP). It provides SOP authors and write effective Change Control the tools to write easy-to-follow Documents. This course enables procedures, policies, and work instructions participants to successfully plan the in an effort to decrease SOP deviations, and Change Control document with three key improve employee task performance. statements in order to clearly communicate the change that occured. WRITING VALIDATION DOCUMENTS This course teaches basic principles and applications of technical writing in validation documents, including Master Validation Plans (MVP), validation plans, and validation reports. This course defines validation documentation, and clarifies expectations for validation doucments. 12

QUALITY RISK MANAGEMENT The Quality Risk Management training course helps participants effectively manage risk as a formalized system. Course participants will learn principles and applications as they apply to ISO 14971:2012 and ICH Q9 guidelines, and become acquainted with the necessary tools, techniques and skills for effective implementation of risk management. 13

BENEFITS for Quality Risk Management Reduce risk in systems and processes. Improve risk awareness and identify risk measures. Connect risk review to your internal quality system processes. Provide a documented, approved rationale for your decisions. 14

INTRODUCTION Define risk and identify roles in risk management. Explain current regulatory requirements for risk management. Identify the components of the quality risk management process. PROCESS Initiate a risk project and identify appropriate personnel for a quality risk management team. Focus on risk identification, analysis, evaluation, reduction and acceptance. TOOLS Apply and establish risk acceptance criteria for the project using tools such as, process maps and brainstorming. Create an FMEA and/or FTA, to understand the tools available to support the Risk Management System. 15

Available Modules for Quality Risk Management QUALITY RISK MANAGEMENT This two day training course will help you understand hazards and risks in designs systems and processes to appropriately apply Risk Assessment Tools. Connect risk review to your company’s quality system processes and provide a documented, approved rationale for your decisions. 1.5 CEU RISK FOR MEDICAL RISK FOR DEVICES PHARMA Course participants will learn principles This Quality Risk Management training and applications as they apply specifically course is designed to help effectively to ISO 14971:2012. Understand how to manage risks as a formalized system for effectively manage risk for patients, pharmaceutical and/ or operators, equipment, and the biopharmaceutical manufacturing. surrounding environment. Course participants will learn principles and applications as they apply specifically to ICH Q9. FAILURE MODES & EFFECTS FAULT TREE ANALYSIS (FMEA) ANALYSIS (FTA) The PathWise FMEA training course uses The PathWise Fault Tree Analysis (FTA) concepts and steps that align with ISO training course uses concepts and steps 14971 and ICH Q9 guidance related to that align with ISO 14971 and ICH Q9 FDA Quality Risk Management. This training guidance related to Quality Risk will ensure the proper understanding Management. Understand how, and when and use of the FMEA tool will build a to use the FTA. culture that emphasizes prevention of issues or problems. 16

QUALITY CHANGE CONTROL Change Control is inevitable in a quality system. Modifications and changes are made at all stages. The PathWise Quality Change Control Training course helps ensure the change control process produces the most cost-effective use of resources when implementing change. The training will also ensure you have minimal disruption to services, reduction in back-out activities, and a compliant approach to managing change in your company. 17

BENEFITS Lower costs for change by using a standard approach. Assess and prioritize changes within the Quality System. Streamline expectations for change documentation. Identify and use tools in each phase of the system. 18

INTRODUCTION Define the regulations. Understand roles and responsibilities. Know causes for change. Know when Change Control begins. Review change control process model. INITIATION Explain the importance of the Initiation Phase . Describe where changes come from. Define what happens in the Initiation Phase. Identify all information necessary to initiate a change. Document the Initiation Phase outcome. 19

Available Modules For Quality Change Control QUALITY CHANGE CONTROL This two day training course helps ensure the most cost-effective use of resources when implementing change. The training will also ensure you have minimal disruption to services, reduction in back-out activities, and a compliant approach to managing change in your company. Ensure change is needed, documented, and does not produce a negative impact to processes or systems. 1.5 CEU TECHNICAL WRITING FOR CHANGE CONTROL Writing for Change Control training provides the model and specifics to create and write effective Change Control Documents. This course enables participants to successfully plan the Change Control document with three key statements in order to clearly communicate the change that occured. Technical Writing principles is a prerequisite for this course. 20

Quality Systems and Regulations With these instructor led training courses, attendees learn more about the laws and regulations that govern the life science industry. Understand the regulations, and how they drive your business and compliance drivers. 21

BENEFITS Fulfill new hire and annual FDA training requirements Hands-on activities to apply to your quality system Drive and support compliance understanding Identify and use tools in each phase of the system 22

Available Courses for Quality Systems and Regulations Quality System Current Good Regulation QSR Manufacturing Practices This course is an in-depth discussion of why cGMP the Quality System Regulation is important and how it supports your business and This course provides a thorough breakdown compliance drivers. The course contains a of the current Good Manufacturing Practice breakdown of the QSR requirements, non- (cGMP) requirements from the FDA, and compliance consequences and subpart other world regulatory bodies, and why detail, highlighting the differences between they are important to your business and FDA and ISO standards. compliance drivers. This course covers subparts located within 21 CFR Parts 210 & Biologics 211, part 600 for Biologics, ICH Q7 and Q9, as well as Good Documentation Practices. This course provides an in depth breakdown of the FDA requirements in 21 Good Documentation CFR 600, 601, and 610. These FDA Practices requirements are important and support your business and compliance drivers. This course discusses why GDP is important. It gives an in depth explanation of the expectations, for good documentation, and how GDP supports your business and compliance drivers. The course provides a breakdown of the requirements, and shares best practices and industry standards for GDP. EU MDR s course covers the changes from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) April 2017- May 2021 for the European Union. 23

Human Factoring Records The PathWise Human Factoring Records training course is designed to introduce human factors into document design in your organization. We use an interactive approach to show you how to apply this methodology into your documents. Human Factoring Records trains organizations to analyze and revise records so they do not lead to errors. Identify key influences in Human Performance and Factoring Records Understand types of errors with records Apply Human Factoring Techniques Utilize the feedback loop 24

BENEFITS Understand how operational modes impact use of documents Know how the human brain processes information Be prepared for error traps that influence document users 25

BENEFITS Understand how operational modes impact use of documents Know how the human brain processes information Be prepared for error traps that influence document users 25

Training In today’s business environment, preparing internal trainers/facilitators offers flexibility and significant cost advantages. Our two day Train-the-Trainer course prepares your organization with excellent training skills to support classroom and small group delivery. We focus on training delivery and content skills for each participant. This robust process creates trainers with excellent classroom management skills for your ever-changing training needs. 26

BENEFITS Develop Skills and knowledge within your organization Understand Adult Learning Models Better facilitate group dynamics during group interactions Use both verbal and nonverbal presentation skills 27

ePath is the PathWise online learning management system. Courses are knowledge based web training that focus on terms, definitions, regulations and expectations. Modules can be purchased for individuals, small, or large groups. 28

BENEFITS There are many benefits for your organization when you choose PathWise Training. CONTINUING PathWise is accredited by the International Association for Continuing Education and Training EDUCATION CREDIT (IACET).As a result of this accreditation, PathWise is accredited to issue the IACET CEU. FULFILL FDA Ensure employees are receiving consistent training LEARNING across the board, whether it is for new employee REQUIREMENTS onboarding, or to maintain annual training records. FLEXIBLE MOBILE Use a desktop, laptop, tablet or phone. Our web based training can be accessed anywhere online! LEARNING REGULATION & ePath training covers many important regulations COMPLIANCE and best practices. Ensure employees have the knowledge for a compliant, effective and efficient quality system. OPTIMIZE Complete training when and where it works for TRAINING TIME your employees, and your organization. 29

PathWise Compliance Web COMPLIANCE Based Training (WBT) modules teach the laws and regulations Learn about the laws that govern the regulated life and regulations that science industry. This group of govern the regulated life knowledge-based online training focuses on terms, definitions, science industry. regulations and expectations. 30

COMPLIANCE TRAINING MODULES Biologics Combination Products This course provides attendees with a high level understandign of the FDA requirements for This course provides a clear regulatory biologics in 21 CFR parts 600, 601, and 610. understanding of the obligations manufacturers Major topic areas covered are general of Combination Products have. It focuses on the requirements, licensing, and biologics Guidance Document issued by the FDA in standards. January 2017 for cGMP requirements for combination products. Current Good Manufacturing EU MDR Practices (cGMP) The PathWise online training module covers the This course focuses on 21 CFR Part 210 & 211 key changes in the updated regulation, cGMP in Manufacturing, Processing, Packing, or including important terms and dates, and Holding of Drugs and Finished Pharmaceutical. provides a framework to complete a Gap It discusses the role of the FDA in the cGMP Analysis to ensure your organization is ready to process, the requirements from the FDA, and transition to the new standard. subpart detail. Good Clinical Good Documentation Practices (GCP) Practices This one hour training will help you understand This course helps your organization be GCP, including the updates to the regulations in consistent in documenting activities to exceed E6(R2), ICH E6(R1), how the regulation came to regulatory expectations. The course provides a be, and why they are essential for your breakdown of the requirements, and shares organization. best practices and industry standards for GDP. AVAILABLE IN SPANISH. 31

COMPLIANCE TRAINING MODULES ISO 13485 Quality System Regulation (QSR) The PathWise ISO 13485 training for medical device manufacturing online course covers This course discusses why the QSR is important, outlines key areas, including documentation, and how it supports your business and definitions, and the additional emphasis on risk compliance drivers. The course provides a management and risk-based decision making. breakdown of the QSR requirements and includes subpart detail, and highlights the differences between FDA and ISO standards. AVAILABLE IN SPANISH. 32

With the PathWise Quality Quality Systems Systems Web Based Training (WBT) Modules you and your Learn about the team can learn about different important pieces to pieces of your quality building a compliant, management system, to ensure effective, and efficient your product is up to regulations, and meets your customer’s quality system. needs. 33

QUALITY SYSTEM TRAINING MODULES INTRODUCTION TO INTRODUCTION TO HUMAN INVESTIGATIONS AND CAPA FACTORS AND PERFORMANCE The Investigations and CAPA training module This training discusses a basic understanding of discusses a high-level understanding of why the Human Performance, introducing Human Investigations and CAPA is important, and how Factors and Performance into your it supports your business. It also highlights organization. It provides an overview of the important terminology , regulations, and influences in human factors and performance requirements. to systems, organizations, and people. AVAILABLE IN SPANISH. INTRODUCTION TO QUALITY INTRODUCTION TO QUALITY CHANGE CONTROL RISK MANAGEMENT This training module focuses on best practice This course covers covers Quality Risk approaches to support the quality change Management key terms, and what the FDA control system. It outlines the change control requires in defining the Quality Risk process, the related regulations, and provides Management process. It describes the Risk background for you employees and partners to Models used in both Medical Device and understand the system’s importance. Pharmaceutical industries, including available tools best suited for each situation. INTRODUCTION TO INSPECTION TECHNICAL WRITING READINESS This course focuses on a high-level This three-module course teaches how to understanding of technical writing and why it is prepare, what to expect, the roles and important to your business and compliance responsibilities, and how to manage an drivers. Learners will learn the expectations for inspection. The modules can be assigned technical writing, and discover key steps in independently to different personnel in your planning and preparing documents. organizatio 34

Productivity Learn about how to improve productivity in your organization. With the PathWise Productivity Web Based Training (WBT) Modules you and your team can learn about how to improve productivity in your organization. Learn how best to utilize your resources, and utilize your staff to their full potential 35

PRODUCTIVITY TRAINING MODULES EFFECTIVE MEETING PROJECT MANAGEMENT MANAGEMENT This two part web based training module Placeholder. focuses on planning and executing effective meetings in your organization. Learn why meetings are important, what roles are involved, how to best plan for meetings, and how to overcome challenges that may arise. 36

PathWise has a library of over 50 presentations of recorded webinars on various quality system topics, including Investigations, CAPA, Risk Management, and more! New webinars are added every 6-8 weeks. 37

WHAT ARE WEBINARS? Webinars are one hour presentations from quality experts on various quality system topics. The instructor guides the training with a slide presentation, and allows for Q&A in the last 10 minutes of the hour. Attendees at live sessions will be able to ask their own questions, and On-Demand viewers will benefit from the questions asked by others during the live presentation. 38

SOME OF THE WEBINAR TITLES AVAILABLE IN THE PATHWISE ON DEMAND LIBRARY WRITE EFFECTIVE KEY RISK BASED STATEMENTS FOR ROOT CAUSE DECISION MAKING IN INVESTIGATIONS QUALITY SYSTEMS It is very important to recognize the relationship Regulated companies work very hard to of the different steps in the investigation phase, incorporate risk management into daily the key statements in each phase, and the company activities. This requires the relationships of those key statements. Crafting development and use of systematic processes those statements well will improve the quality designed to coordinate, facilitate and improve of each activity as well as the Investigation science-based decision making. Report. INSPECTION READY: HOT TOPICS HOW TO DOCUMENT FOR FDA & OTHER REGULATORY QUALITY INVESTIGATIONS INSPECTIONS TO MEET FDA EXPECTATIONS Of course the best preparation for any inspection is to have strong and effective This webinar teaches the writing skills quality systems that are faithfully executed necessary for compliant, effective, and efficient every day. However, even if you are doing all documentation. This webinar will help you the right things, how you present that understand what plain language is, how to information to the inspector can make or break write it, and what the FDA and world regulatory the inspection. bodies expect when it comes to documenting quality investigations. THE CHALLENGES OF USING HUMAN EFFECTIVENESS CHECKS FACTORING IN PROBLEM SOLVING Corrective and Preventive Action (CAPA) is often referred to as the health check of the quality Problems arise every day. Our approach to system- a central point where all non- problem solving is frequently to find the fastest conformances and deviations are recorded and solution. Sometimes those solutions work… addressed through the required CAPA process. Sometimes those solutions fail. This webinar Because of this, they are an area that is will focus on how to use Human Factoring regularly scrutinized by inspections. techniques in problem solving. 39

ADDITIONAL WEBINAR TITLES 483 Observations and How They Impact Best Practices for Investigating Deviations Complaint Handling Assessment Tools for Better Writing Seven Habits of Highly Effective Writers How to Qualify Lead Investigators for CAPA Benefits of e-Learning Handling OOS Test Results and Completing Capturing Justifications Robust Investigations Changes in ISO 13485 How do You Know Your Training Was Defining Training in the Life Science Industry Effective Developing Useful Quality Metrics How to Manage Change in a cGMP Establishing a Compliant and Effective Risk Environment Based CAPA System Quality Event Discover and Review Everything You Want to Know About the FDA SOP Writing Tips and Tricks Quality Metric Guide The Causal Chain Process- Going Beyond the How our Quality System Interrelates 5 Whys How to Prepare for a Quality or FDA Audit Training and Qualification in a Quality How to Respond to FDA Warning Letters System Human Factoring Records Using the Fishbone Diagram to Identify Root Successful Complaint Handling Cause Understanding Organizational Culture and Why the FMEA is NOT your Quality System Human Performance Current Status of the MDSAP Industry in Transition: The EU MDR 745/2017 Understanding ISO 13485:2016 Inspection Readiness- Trends and Hot Topics Complex Skills Training Programs for Regulatory Inspections Conducting Third Party Audits Equipment Maintenance in Assuring Product ISO 14971- Updates and Changes Quality Complex Skills Training Programs Implementing a Change Control System What to Do When You Can't Find Root Cause Effectively Analyzing your Data Human Error is Not a Root Cause How to avoid drift and ensure your Good Risk Based Environmental Monitoring Laboratory Practice (GLP) protocol is Changes and Updates to ISO 14971:2019 compliant Do your SOPs Need a CAPA investigation? The Fault Tree Analysis The FMEA Combination Products Quality System Management Effectiveness Getting to Root Cause- The Is/Is Not Tool Building a Culture of Quality Implementation and Management of GMP Data Integrity 41

PATHWISE ONLINE UNIVERSAL LICENCE Training is an ongoing necessity in our regulated life science industry. 21 CFR 820.25, and 21 CFR 211.25, both outline requirements to show the FDA that we have trained personnel, who understand the intricacies of their respective jobs, are qualified to perform their job functions, and even that they are trained with “sufficient frequency.” Use the PathWise Online Universal License, with self-paced online learning modules, and on-demand webinars, to remain compliant, effective, and efficient. $1,095 FOR 12 MONTHS OF ACCESS OVER 70+ ONLINE TRAINING COURSES EARN CEU CREDIT WITH EVRY COURSE REMAIN FDA COMPLIANT RECIEVE UP TO DATE TRAINING CONTENT DOWNLOAD A LEARNING CERTIFICATE FOR TRAINING RECORDS FOR EVERY COURSE 42