Refreshers and Tutorials Apple

Tutorials: One, two and three day pre-conference tutorials will be conducted on October 9, 10 & 11, 2017. These great pre-conference Tutorials that will benefit the attendees or target audience and enhance your management, auditing, and other quality related skills and knowledge. These are a special offering outside the conference for an additional fee unless otherwise indicated.

Instructor Bios Click here to download the instructor bios.


Pre-conference Workshops
Monday, October 9, 2017 – Wednesday, October 11, 2017
#9983ILT Certified Quality Auditor Exam Refresher
WKSP13 Certified Software Quality Engineer Preparation Overview
Tuesday, October 10, 2017 – Wednesday, October 11, 2017
WKSP3 ISO 9001:2015 Internal Auditing
Monday, October 9, 2017
WKSP1 Optimizing Risk Assessment Interviews
WKSP14 Synthesizing the ‘Process Approach’ via the P-D-C-A model
Tuesday, October 10, 2017
WKSP2 Keys to being an Effective Audit Manager
WKSP7 The Supplier Audit Program – Managing Organizational Risk and Meeting ISO 9001:2015 Requirements
WKSP8 Pharmaceutical GMP Professional (CPGP) Review Day and Preparation for the Exam
WKSP9 Certified HACCP Food Safety Auditor (CHA) Exam Prep
Wednesday, October 11, 2017
WKSP4 Evolving the Internal Audit Process
WKSP5 A Brief Introduction to Supplier Management
WKSP6 An Introduction to Statistical Process Control and Acceptance Sampling

Monday, October 9, 2017 – Wednesday, October 11, 2017


8:00 AM – 5:00 PM Workshops
#9983ILT: Certified Quality Auditor Exam Refresher
Presented by: Kevin Posey
8:00am – 5:00pm (Monday, Tuesday, and Wednesday)
This workshop will be an exam refresher to help experienced auditors become better prepared for the CQA exam. The basis for the exam is the CQA Body of Knowledge and class discussion will include an overview of the CQA BoK offering participants a better understanding of the basic principles and applications that will appear on the exam. All course participants will receive a three ring binder containing the entire power point presentation and the CQA Handbook,  Fourth Edition as the course text.
Price: $995
RUs: 2.4
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WKSP 10: Certified Software Quality Engineer Preparation Overview
Presented by: Linda Westfall
8:00am – 5:00pm (Monday, Tuesday, and Wednesday)
The ASQ Certified Software Quality Engineer (CSQE) Body of Knowledge (BoK) is a comprehensive guide to the “common knowledge” software quality engineers should possess about the knowledge areas of:

Software quality management. The processes and activities involved in setting the organization’s strategic quality goals and objectives, establishing organizational, project, and product quality planning, and providing the oversight necessary to ensure the effectiveness and efficiency of the organization’s software quality management system.

Software quality engineering. The processes and activities needed to define, plan, and implement the quality management system for software-related processes, projects, and products. This includes defining, establishing, and continuously improving software-related systems, policies, processes, and work instructions that help prevent defects and build quality into the software.

Software quality assurance. The planned and systematic set of all actions and activities needed to provide adequate confidence that the:
     • Software work products conform to their standards of workmanship and that quality is being built into the products
     • Organization’s quality management system (or each individual process) is adequate to meet the organization’s quality goals and objectives, is appropriately planned, documented, and improved, is being followed, and is effective and efficient.

Software quality control. The planned and systematic set of all actions and activities needed to monitor and measure software projects, processes, and products to ensure that special causes have not introduced unwanted variation into those projects, processes, and products.

Software verification and validation. The processes and activities used to ensure that software products meet their specified requirements and intended use. Verification and validation help ensure that the “software was built right” and the “right software was built.”

Soft skills. A software quality engineer also needs what are referred to as the “soft skills” to be effective in influencing others toward quality. Examples of “soft skills” include leadership, team building, facilitation, communication, motivation, conflict resolution, negotiation, and more.

This tutorial contains information and guidance that supports topics of the 2016 version of the CSQE BoK upon which the CSQE exam is based. Armed with the knowledge presented in this tutorial to complement the required years of actual work experience, qualified software quality practitioners may feel confident they have taken appropriate steps in preparation for the ASQ CSQE exam. However, the goals for this tutorial go beyond it being a CSQE exam preparation guide. It is designed not only to help the software quality engineers but as a resource for auditors, software development practitioners, project managers, organizational managers, other quality practitioners, and other professionals who need to understand the aspects of software quality that impact their work.

Expected Takeaways:
1. Armed with the knowledge presented in this tutorial to complement the required years of actual work experience, qualified software quality practitioners may feel confident they have taken appropriate steps in preparation for the ASQ CSQE exam. Attendees will receive the workbook from our 5-day CSQE Preparation course, which includes detailed notes on all the topics from the ASQ Certified Software Quality Engineer Body of Knowledge. This allows students to study the more general topics not covered during this tutorial. It also provides an excellent reference for attendees to take into the open book CSQE exam.

2. Students will learn techniques that they can use to implement and improve software quality practices in their organization.

3. Students will practice CSQE example questions during the tutorial and receive a CD with three complete 160 practice exams (including answers, explanations and CSQE references) they can use to practice for the exam.

Price: $995
RUs: 2.4
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Tuesday, October 10, 2017 – Wednesday, October 11, 2017

WKSP3 – ISO 9001:2015 Internal Auditing
Presented by: Bob Deysher
8:00am – 5:00pm (Tuesday and Wednesday)
This interactive course employs a metrics-driven, process-based approach to the theory and practice of conducting value-added audits to the ISO 9001:2015 Standard. It prepares internal auditors to perform effective process audits and helps managers and supervisors take full advantage of the internal audit process. Training includes a detailed review of all elements of ISO 9001:2015, effective implementation, and the benefits of quality management systems. This course meets the training portion of the requirements for certification of individual internal auditors. Training also addresses the requirements of the ISO 19011:2011 Auditing Standard. This workshop is a comprehensive review of the theory and practice of the ISO 9001:2015 Standard and Internal Auditing. Training topics include:
• The Challenge for Top Management
• Quality Management Principles
• The ISO 9001 Standard Explained
• The ISO 9001 Family of Standards
This session includes a detailed review of all elements of the ISO 9001:2015 Standard. Participants will also gain an understanding of Customer Oriented Processes (COPs), as well as the customer-specific requirements defined by ISO 9001:2015.

During this workshop, students will explore effective auditing techniques, interviewing skills, communication skills, and teamwork concepts through a series of interactive workshops, simulated audits, tutorials, and case studies. Training includes a discussion about internal auditing metrics. Specific topics include:

• Introduction to ISO 9001 Audit Trails
• Documentation for ISO 9001
• The audit cycle and ISO 19011
• Introduction to Quality Audits
• Management of Audit Programs
• Audit Planning and Preparation
• Scope and Objectives
• Audit Plan
• Performing the Audit
• Opening Meeting
• Quality Audits
• Conducting the Audit
• Writing Nonconformity Statements
• Writing Nonconformities (using CARs)
• Closing Meeting
• Summary Statement and Closing Meeting
• Completing the Audit Report
• Corrective Action and Close Out (using CARs)
• Verification and Close Out
Through training, participants will:
• Gain a working knowledge of a quality management system based on the requirements of ISO 9001:2015
• Enhance their understanding of process-based, metric-driven auditing techniques
• Learn the requirements of ISO 9001:2015 and understand its inter-relationship with other elements of the ISO family of standards. Role-play exercises give students practical experience with auditing
Price: $695
RUs: 1.6

One Day Workshops

WKSP1 – Optimizing Risk Assessment Interviews
Presented by: Danny Goldberg
8:00am – 5:00pm (Monday)
Interviewing is a very important skill in the risk assessment process.  To effectively communicate and ease the concerns of the client is as an important as an effective audit process.  This one-day course will take attendees through the entire interview process, learning leading practices for each step and how to manage different personality types.

Auditors, in many organizations, face an uphill battle when building rapport and strong relationships with clients.  The face-to-face time afforded during the interview process can not only be valuable from a risk assessment perspective, but can play a pivotal role in many other facets of the assessment/audit process, including:

• Building trust
• Building rapport/relationships
• Assessing fraud risk
• Understanding of the controls and process
• Understanding the rumor mill
• Getting a better feel for how the process works (versus how it is documented)
A simple theory in relationship building is as follows: people take care of people they like; people don’t help people they don’t like.  Since many clients believe that the audit/risk assessment process is not their responsibility, this is viewed as “optional”.  Regardless, human nature has proven that if you force people to do things, they will do it but begrudgingly.  However, if you show the value and reason you are requesting the information and build a relationship with the client, you will not only get your information but most likely will receive it quicker.   This course will take attendees through all facets of the interview process and how to get clients to “buy-in”.

Expected Takeaways:

• Overview of best practices in audit interviewing, including personality types and interview preparation.
• Learn the step-by-step audit interview process and learn best practices for each step.
• Learn how to listen actively and read physical cues.
Price: $595
RUs: 0.8
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WKSP14 – Synthesizing the ‘Process Approach’ via the P-D-C-A model to Expose and Eradicate Non-Value Time and Space
Presented by: Jeff Bostow
8:00am – 5:00pm (Monday)

This pre-conference workshop / tutorial will actively explain and demonstrate what is referred to as “The Process Approach” in ISO 9001:2015. The specific content of how The Process Approach is displayed in this session can be applied to any organization and per any quality management system. Since all organizations use processes to achieve their interested parties’ objectives, the content provided here will accurately display and depict a process as “a risk-assessed set of interrelated activities that use inputs and a value-added transformation to deliver an intended output (typically, the delivery of a product and/or a service; but more specifically, the attainment of a defined goal).”

The Process Approach will be oriented and grounded in the Shewhart-Deming P-D-C-A cycle of continuous development and improvement. From the P-D-CA model, the content will seamlessly blend from an initial concept into a process view of the cycle and will display specific functional steps of each cycle piece, (e.g., the ‘Plan’ component will be comprised of the following five steps: 1. Identify and Select the Priority Process, 2. Conduct a Risk Mitigation Assessment, 3. Document the Work Process, 4. Identify Interested Party and External Provider requirements, and 5. Develop Indicators and Build the QMS). The ‘Do’ component will be presented as an action (more specifically a project) plan (Embrace the Present). The final cycle pieces of ‘Check and Act’ will explore both process stability and process capability using continuous (variables) data examples and will examine where the existence of nonvalue time and space may inadvertently co-exist. This exposure provides the Quality Auditor with the ability to be more insightful when conducting either partial or full system assessments (Prepare for the Future) upon conference adjournment.

Price: $595
RUs: 0.8
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WKSP7 – The Supplier Audit Program – Managing Organizational Risk and Meeting ISO 9001:2015 Requirements
Presented by: Lance Coleman
8:00am – 5:00pm (Tuesday)
Risk Elimination. Risk Management. Risk Mitigation. These words are an increasingly important part of the lexicon of executive level management as they strive to succeed in a business environment having global competition, geographically diverse suppliers and new technologies. In this new globally expansive marketplace more than 50% of value creation is achieved outside of an organization’s walls or in other words through their suppliers. In the United States, recent studies show that 100% of manufacturers include at least one element of their finished product that is obtained from outside of the organization. This too is where the majority of product realization risks lies. Learn how to apply principles that will develop a robust supplier audit program to help manage organizational risk. This curriculum is in alignment with key aspects of the Certified Supplier Quality Professional body of knowledge as well as, the Certified Quality auditor body of knowledge.
Learning Objectives

• Risk Management Overview
• Understanding risk based thinking as it applies to the supplier audit program
• ISO 9001:2015 requirements relating to supplier monitoring and control
• How to conduct a successful risk based supplier audit

Attendee Takeaways

• Introduction to the Three KeysTM model of supplier auditing
• External Provider Management Matrix
• Useful templates for use in supplier auditing

Who should attend?

• Quality auditors, managers and engineers
• Supply Chain professionals
• Anyone who participates in supplier auditing
Price: $595
RUs: 0.8
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WKSP8 – Pharmaceutical GMP Professional (CPGP) Review Day and Preparation for the Exam
Presented by: Teresa Sowinski
8:00am – 5:00pm (Tuesday)
Through group discussion and shared experiences, participant will gain a better understanding of the eight areas of the CPGP Body of Knowledge which include: Regulatory Agency Governance; Quality Systems; Laboratory Systems; Infrastructure: Facilities, Utilities, Equipment; Materials and Supply Chain Management; Sterile and Nonsterile Manufacturing Systems; Filling, Packaging, Labeling; and Product Development and Technology Transfer. Knowledge gained should complement the information available from the ASQ tutorial and references used for CPGP certification.
Successful manufacturing site audits entails preparation and strategic planning. These not only help you save time but can provide focus and scope for the auditing team. This tutorial will also provide examples on how to best prepare for audits, and what has and has not worked for others in the past. Only by learning from the past we can improve the future.
Analysis and discussion of current public information on policies and real cases as posted in FDA website would be helpful to participants. Inclusion of analogies, and exceptions to the current FDA policies, Industry guidance, and cases would complement participants’ discussions.
Through practice we can achieve perfection. As time permits, participants will also work in team in hypothetical circumstances to practice their new gained skills and knowledge. This will help participants understand how to apply concepts and share knowledge gained in this tutorial. As a result, manufacturing sites will benefit of a better compliance to the FDA Law, ensuring good manufacturing practices and safer product manufacture. Good quality products not only has a direct relation to profits to manufactures but most important, ensures public health for the consumers.
Expected Takeaways
• Discuss, study and analyze public information and real cases as currently posted at the FDA website
• Gain different perspectives on how to approach audit findings based on current GMPs interpretation
• Share experience among participants addressing common questions and further gaining knowledge
• Prepare attendees to take the Certified Pharmaceutical GMP Professional (CPGP) examination
Price: $595
RUs: 0.8
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WKSP9 – Certified HACCP Food Safety Auditor (CHA) Exam Prep Manager
Presented by: Aura Stewart and Tatiana Miranda
8:00am – 5:00pm (Tuesday)
A Certified HACCP/Food Safety Auditor (CHA) is a professional auditor who understands the food safety principles and good manufacturing practices used in the production, manufacturing, and distribution of food products. This 8-hour refresher training allows CHA candidates to reinforce the knowledge necessary for taking the certification exam. This session is divided in parts, · Part 1. The HACCP System: HACCP Foundation, HACCP Principles, and the HACCP System: Implementation and Maintenance. · Part 2. Auditing: Auditing Fundamentals, Auditor Competencies. · Part 3. Test Taking Techniques and Practice Questions. This refresher training does not cover part V (Applying the HACCP to the Food Processing Industry) and Part VI (Applying HACCP to the Medical Device Industry) of the Certified HACCP Auditor Handbook. It is expected that attendees study that material on their own. The completion of this refresher training does not guarantee passing the exam. Expected Takeaways: Attendees to this refresher training will have the opportunity to · Ask questions pertaining to the exam’s body of knowledge. · Obtain insights about best practices for passing the certification exam. · Discuss review questions created by the CHA Auditor Handbook and author of several actual exam’s questions.
Price: $595
RUs: 0.8
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WKSP2 – Keys to being an Effective Audit Manager
Presented by: Linh Truong
8:00am – 5:00pm (Tuesday)
Becoming an Effective Audit Manager helps auditors transition to management and become active leaders for their audit teams. This training course gives Managers oversight on how to review a file, properly budget and forecast projects and actively manage and juggle numerous projects. Auditors should not get promoted without taking this course. Moving from staff auditor to audit manager calls for expanding the skills set. Not only do managers have to be efficient audit team members but also effective communicators, teachers, and active listeners.

Objectives:
• Learn how to identify audit risk and appropriate audit planning tools and techniques
• Learn how to manage the audit process from planning to follow-up
• Discover the best interpersonal and team building skills
• Discuss audit communication and budgeting and forecasting techniques
• Further understanding of the audit report creation process
• Learn more about public speaking and presentation best practices

Agenda:
1) Introduction and Background
a. What are the roles and responsibilities of an audit manager The evolution of
b. auditor to manager
2) The Risk Assessment Process
a. Audit manager roles
b. Audit preliminary work
c. Audit preliminary risk assessment
3) Managing an Audit Engagement
a. Appropriate audit planning
b. Developing an audit work program
c. Managing a budget and schedule
d. Delineation of duties
e. Reviewing an audit file
4) Managing an Audit Team
a. Personality types/styles
b. Managing minimal age differences
c. Deadline management
5) Internal Audit Wrap Up
a. Audit reporting
b. Effective exit conferences
c. Audit follow-up
6) Managing Up
a. Managing expectations
b. To commit or not to commit
7) Communication
a. Interpersonal Skills
b. Managing the Auditee
8) Time Management
9) Public Speaking and Presentations
10) Creating/Reviewing Audit Findings and Reports

Price: $595
RUs: 0.8
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WKSP4 – Evolving the Internal Audit Process
Presented by: Linh Truong
8:00am – 5:00pm (Wednesday)
The internal audit profession is very similar to other professions; very resistant to change. When one of our profession’s main goals is to promote efficiency and effectiveness, we have to be more adept at adjusting and being open-minded to change. Audit2020 takes an in-depth look at the accepted practices inherent in internal audit and critically analyzes each piece, identifying ways to enhance the current view and process of internal auditing.

Objectives:
• Criteria to identify key/significant controls
• Identify the most efficient controls to test
• Understand the differences between control
• Learn about ways to test controls the most efficiently and effectively

Agenda:
1) Annual Risk Assessment
a. What is a continuous risk assessment?
b. Assessment modes
c. Assessing emerging risk
2) Foundational Pieces of Successful Internal Audit Departments
3) Audit Cycle
a. Audit planning
1. Percent of audit cycle – new vs recurring audits
2. Components of audit planning
3. Kick off meeting- Who/What/Why and for how long?
4. Formality of engagement risk assessment
5. Risk categories
6. Using a true top-down risk-based approach
7. What should I test and why?
8. Building an effective and efficient audit work program
b. Fieldwork
1. Percent of Audit Cycle – New versus Recurring Audits
2. Timing & Contents of PBC List
3. Sampling Methodology
4. What support to keep and why?
5. Presenting Observations to Clients
c. Reporting/Wrap-Up
1. Percent of Audit Cycle – New versus Recurring Audits
2. Do We Even Need a Formal Report?
3. Timing of the Audit Report
4. Audit Reports – Emerging Formats
5. What Words NOT to Use & What to Replace them with
d. Follow-up
1. Correlation between Finding Type and Follow-Up Method necessary
2. Timing of Follow-Up
4) Transparency and Continuous Communication

Price: $595
RUs: 0.8
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WKSP6 – An Introduction to Statistical Process Control and Acceptance Sampling
Presented by: Steven Schuelka
8:00am – 5:00pm (Wednesday)
Many of us are not required to employ Statistical Process Control and Acceptance Sampling tools as part of our daily job but do need an understanding of how the tools function in order to work effectively with those that use the tools regularly for continual improvement purposes, or even to audit those that do use the tools. This workshop is aimed towards participants learning about Basic Statistical Process Control and Acceptance Sampling. The morning will start with several relatively simple problem solving tools that are used by organizations to help find solutions to quality-based problems. Using these data gathering methods, the rest of the morning will focus on statistical process control with the primary topics being Attribute and Variables control charts along with how to determine process capability. The afternoon will transition into a discussion on acceptance sampling including single sampling plans, sequential and skip lot sampling plans wrapping up with a discussion on ANSI sampling plans. Attendees will actively participate during the day in using these tools so bring a calculator and a willingness to learn.
Expected Takeaways:

• Understanding of the 7 Basic Quality Tools
• Learning how to construct Attribute and Variables
• Fundamental knowledge of Acceptance Sampling
Price: $595
RUs: 0.8
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WKSP5 – A Brief Introduction to Supplier Management
Presented by: Aimee Siegler
1:00pm – 5:00pm (Wednesday)
A brief introduction to supplier management is a great way to start building your supplier management skills. Learn or refresh your knowledge of the basics of how to get started on a supplier management program. If you’re considering working on the Certified Supplier Quality Professional (CSQP) Certification, this is a great way to get started. No previous knowledge of supplier management is required. This short version of the Customer-Supplier Division’s course, “Introduction to Supplier Management” covers these topics:
Why is a Supplier Management Program Necessary?
Where do we start?
Building Your Supplier Management Tool Kit
Basic Inventory of Your Existing Supplier Management Base
Improving Your Existing Supplier Base
Selecting New Suppliers
Supplier Certification and Ship-to-Stock
While this course is just a brief introduction to these topics without the hands on application included in the full version, it will give participants the opportunity to explore these topics as well as the resources available to them within ASQ. These elements also align with the new CSQP, allowing participants to learn about topics that need to be considered in preparation for the exam, although this course is not an exam prep course. Participants will also have the opportunity to share their own experiences and learn from each other as time allows.
Expected Takeaways

• Understand the basics of effective supplier management
• Be equipped with knowledge of the functional roles in supplier management
• Learn tools of a complete supplier management program
Price: $295
RUs: 0.4
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