April 2012 SQA Quality College

Course Descriptions

Miami, Florida, USA
22, 23 and 27 April 2012

The April 2012 Quality College is being held in conjunction with the 28th SQA Annual Meeting.  Please see the "Hotel" tab of the Annual Meeting page for details on reserving rooms at the special group rate. The special rate guarantee ends 30 March 2012.

REGISTER ONLINE on or before 26 March 2012 to take advantage of reduced early registration fees. 

1 - Basic Training: Good Laboratory Practice
2 - Good Clinical Practice: Understanding the Basics
3 - Basic Concepts in Computer Validation
4 - Developing a GLP-Compliant Program in a University Setting
5 - Train the Trainer: Effective Teaching Strategies
6 - Development of Multiple-Choice Questions in GCP and GLP
7 - From Lab to Market: Getting Regulatory Approval
8 - SQA Leadership Development
9 - Archiving 101: What You Need to Know About GLP-Compliant Archives
10 - Current Trends in cGMP
11 - Process Mapping to Increase Auditing Quality and Effectiveness
12 - Improving the Impact of Quality Assurance: Value-Adding Strategies for the 21st Century
13 - Current Topics in Good Laboratory Practice
14 - Good Clinical Practice: Beyond the Basics
15 - Good Practices: Understanding the GxP Regulations Using a Quality System Approach
16 - Common Challenges in Non-Clinical Medical Device Compliance
17 - Continual Quality Improvement: Expanding the QA Toolbox
18 - GMP for GCP Auditors 

 

1 - Basic Training: Good Laboratory Practice 

TWO DAYS: Sunday and Monday, 22 - 23 April 2012, 8:00 am to 5:00 pm 

Member Rates: $725 through 26 March, $785 after 26 March
Nonmember Rates: $875 through 26 March, $935 after 26 March 

Session Chair: Melinda B Apgar RQAP-GLP, Millennium: The Takeda Oncology Company 

 Speakers: Melinda B Apgar RQAP-GLP, Millennium: The Takeda Oncology Company; Theresa A Donegan MS, Donegan Consulting; Kimberly S Frazier MS, Pfizer Inc; Gregory P Furrow, WIL Research Company; Kathryn A Hackett-Fields RQAP-GLP, Qualistat Inc; Stephen B Rogenthien RQAP-GLP, Ricerca Biosciences LLC; Paul Sidney RQAP-GLP, Charles River Laboratories 

RQAP re-registration units: 4 GLP or 4 non-GCP

Target Audience: 

This course is directed towards study directors and QA personnel (GLP auditors) with 0-2 or more years of experience, and anyone needing to learn about GLP regulations and producing quality in testing/research settings.

Course Objectives: 

After this course, attendees shall be able to:

• inspect and audit GLP-targeted research and testing practices and raw data to assure Management of its compliance or report the lack thereof 
• spot areas in the overall quality system of a facility and suggest improvements based upon regulatory requirements or “best practices” for industry 
• effectively communicate the requirements of, and differences between, FDA, EPA and OECD GLP’s to various levels of facility staff 
• prepare clear, relevant audit report findings for response 
• use a variety of resources for GLP education and reference for continuing education and more effectiveness in their position. 

Course Description: 

This expanded course offers comparisons between GLP requirements of FDA, EPA and OECD, as well as examination of the Preambles, to equip the trainee with a working knowledge of GLP impacts on study conduct. Opportunities for group interaction during the sessions, and as breakout periods, help widen the educational exchange while enhancing the learning process. With more time for presentation and the inclusion of new material, the course introduces Quality System principles while providing excellent GLP Basic or refresher training.

Course Agenda: 

Day 1

• Introduction
• History and Overview of the GLPs
• Scope and Definitions
• Organization & Personnel
• Test System Care & Facilities 
• Standard Operating Procedures (SOPs)
• Equipment and Logs, Q&A
• Test/Control/Reference Substances
• Preview of Day 2 and Solicitation of questions

Day 2

• "MVP – Most Valuable Points I Learned Yesterday"
• Protocols
• Study Conduct and Raw Data
• Final Reports/GLP Compliance Statement examples
• Record Retention, E-data Considerations, Archives
• Disqualification, Effects of Non-Compliance
• Quality Assurance and Regulatory Agency Inspections
• Final Q&A, Closing

 SQA Career Development Map Areas: New QA - GLP; New QA - Science vs. QA; New QA - QA vs. QC; New QA - Ethics and Integrity; New QA - Specific Job Tasks; New QA - Special Topics - Writing good findings

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2 - Good Clinical Practice: Understanding the Basics

TWO DAYS: Sunday and Monday, 22 - 23 April 2012, 8:00 am to 5:00 pm 

Member Rates: $725 through 26 March, $785 after 26 March
Nonmember Rates: $875 through 26 March, $935 after 26 March 

Session Chair: Jacqueline Bushong RQAP-GCP, Amgen Inc 

Speakers: Anthony S Brewer MBA, RQAP-GLP, Brewer Educational Services LLC; Jacqueline M Bushong RQAP-GCP, Amgen Inc; Debra E Fadil, Debra E Fadil Consulting LLC; Paula Hamilton, GCA Quality Solutions Inc; Cheryl M McCarthy CQA, Eliassen Group, eClinical Solutions Division; Louise Messer, Messer, Cagney and Tuce Consulting 

RQAP re-registration units: 4 GCP or 4 non-GLP

Target Audience:

 This course is directed towards Quality Assurance and Clinical Research professionals with less than one year of GCP auditing experience.

Course Objectives:  

Upon course completion, the attendee shall be able to

• Cite key events impacting the evolution of Good Clinical Practices
• Define Good Clinical Practices
• Describe 3-4 activities to be done during an audit
• See what a career in GCP auditing looks like

Course Description:  

This is a basic course providing an overview of the fundamentals of Good Clinical Practices. Some applied knowledge is provided through exercises, but advanced concepts are not within the scope of the training.

Topics to be covered include: A History of GCP, Key Regulations and Guidelines, Basic Safety and Pharmacovigilance, Essential Documents, Informed Consent, Study Roles and Responsibilities, Audits from and FDA Perspective, and the Application of GCPs in Investigator Site Audits, Service Provider Audits, and Internal Process Audits.

Course Agenda:  

Day 1

• A Brief History of GCPs
• Regulations and Guidelines
• Clinical Study Roles and Responsibilities
• The Informed Consent Process
• Basic Pharmacovigilance and Safety
• Essential Documents
• GCPs: An Agency Perspective
• Speaker Q&A Panel

Day 2

• Investigator Site Audits
• Service Provider Audits
• Internal Process Audits
• FDA Sponsor Audits
• Prepping for the audit of Dr. Bob
• Audit Exercise
• Audit Exercise
• Quiz, Feedback and Closing Comments

SQA Career Development Map Areas: New QA - GCP; New QA - Basic Regulatory Process

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3 - Basic Concepts in Computer Validation 

TWO DAYS: Sunday and Monday, 22 - 23 April 2012, 8:00 am to 5:00 pm 

Member Rates: $725 through 26 March, $785 after 26 March
Nonmember Rates: $875 through 26 March, $935 after 26 March 

Session Chair: Joseph A Franchetti, JAF Consulting Inc 

Speakers: Stacey A Blackmer, GlaxoSmithKline R&D; Joseph A Franchetti, JAF Consulting Inc; Patricia M Miller, PRA International; Frank P Moschetto, Roche; Shari L Perlstein, Pfizer Inc; Kevin T Saylor, Millenium Pharmaceuticals Inc; Richard M Siconolfi, Procter & Gamble Co; Joseph P Whittemore, Pfizer Inc 

RQAP re-registration units: 4 GCP or 4 GLP

Target Audience: 

This course is designed for validation, quality, IT and business personnel responsible for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries. The course is of special value to personnel seeking experience with computer validation and issues associated with regulated computer systems. The course is designed for attendees seeking a thorough introductory level of understanding, yet is also designed to be valuable to those with prior experience seeking to remain current with industry trends and approaches.

Course Objectives: 

The course is designed to provide a thorough understanding of computer system validation by providing a framework on how to execute the System Life Cycle.  In addition, the course will address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process.  The attendee will be familiar with expected content for computer validation deliverables through workshop exercises and examination of example documents, as well as how to develop the validation rationale for a variety of circumstances.

Course Description: 

This is a newly designed course with new content and exercises. 

The purpose of this 2-day introductory workshop training session is to provide the QA Professional with an overview of the validation process, regulatory expectations and auditing strategies base on Industry standards and guidance. It also will provide the Course attendees the “how to get it done” by participating in break-out sessions and exercises to enhance their level of understanding the concepts presented. The concepts presented will be based on the industry leading document from the Drug Information Association, Computerized Systems Used in NonClinical Safety Assessment: Current Concepts in Validation and Compliance. This guideline explores the current regulatory environment and new challenges in the development, validation, and use of computerized systems in nonclinical laboratories and describes the best practices to ensure their quality at that time.

Course Agenda: 

Course topics will provide attendees with the information on:

• Understanding the Regulations and Guidelines
• Identifying the Components of the System Life Cycle
• In-depth Look at the Validation Deliverables
• Planning, Conducting and Documenting the Computer Validation Audit

SQA Career Development Map Areas:  New QA - GLP; New QA - GCP; New QA - GMP; New QA - Basic Regulatory Process; New QA - Science vs. QA; New QA - QA vs. QC; New QA - Effective Communication; New QA - Teamwork; New QA - Ethics and Integrity; New QA - Conflict Resolution; New QA - Specific Job Tasks; Developing QA - Project Management; Developing QA - Regulatory Interpretation; Special Topics - Oral Communication; Special Topics - Written Communication; Special Topics - People Management; Special Topics - Dealing with Difficult People 

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4 - Developing a GLP-Compliant Program in a University Setting

ONE DAY AND ONE HALF DAYS: Sunday, 22 April 2012, 8:00 am to 5:00 pm, and Monday, 23 April 2012, 8:00 am to 12:00 pm 

Member Rates: $660 through 26 March, $720 after 26 March
Nonmember Rates: $810 through 26 March, $870 after 26 March 

Session Chair:  Anna-Maria Escherich, UT MD Anderson Cancer Center 

Speakers: Debra A Bridges RVT, RQAP-GLP, Texas A&M Institute for Preclinical Studies 

RQAP re-registration units: 3 GLP or 3 non-GCP

Target Audience: 

QA professionals with 2 or more years of experience, testing facility management, and researchers at academic institutions interested in developing a GLP program. A solid working knowledge of GLP is strongly recommended.

Course Objectives: 

Participants shall be able to:

• Define common challenges in implementing & maintaining a GLP quality system in an academic setting
• Develop knowledge in assessing institutional GLP compliance
• Develop a GLP implementation plan
• Develop assessment tools for measuring GLP program compliance

Course Description: 

Academic institutions have traditionally had a high rate of noncompliance with the GLP regulations. Competition for federal funding and increasing expectations for public private partnerships from funding agencies have increased the demand for institutions that can conduct GLP studies or provide GLP compliant specialized services. In this interactive workshop participants will identify compliance challenges and GLP research opportunities, discuss strategies to evaluate institutional interest and readiness and learn how to construct and implement a GLP compliance program plan for their institution. This session has been expanded and will give participants the opportunity to develop strategies for overcoming challenges at their institutions. Participants are encouraged to submit scenarios in advance to take full advantage of the interactive sessions.

Course Agenda: 

• Identifying opportunities and compliance challenges
• Defining project scope
• Identifying stakeholders and getting stakeholder buy-in
• Establishing an action plan
• Education and promotion of GLP compliance
• Strategic planning and project management
• Monitoring the compliance program
• Assessing outcomes and effectiveness

SQA Career Development Map Areas:  New QA - Effective Communication; New QA - Teamwork; Developing QA - GLP; Developing QA - Project Management; Developing QA - Intro to Risk Management; Mature QA - GLP; Mature QA - Designing a Compliance Program 

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5 - Train the Trainer: Effective Teaching Strategies

ONE DAY: Sunday, 22 April 2012, 8:00 am to 5:00 pm 

Member Rates: $495 through 26 March, $555 after 26 March
Nonmember Rates: $645 through 26 March, $705 after 26 March 

Session Chair:  Cheryl M McCarthy CQA, Eliassen Group, eClinical Solutions Division 

Speakers: Josephine Scrofani CPLP, Eliassen Group, eClinical Solutions Division 

RQAP re-registration units: 2 non-GCP or 2 non-GLP

Target Audience: 

Any QA Professional interested in refining their Train the Trainer techniques.

Course Objectives: 

The participant shall be able to:

• Analyze verbal and non-verbal behaviors and discuss how they impact training
• Review the "Roadmap" and discuss how to incorporate it into all presentations
• Discuss the theory of adult learning and how it must be considered when training
• Review various techniques for engaging and interacting with the audience

Course Description: 

This introductory course has been created to provide the basis for implementing a Train the Trainer program using an interactive approach. Attendees will engage in appropriate exercises that highlight adult learning theory and presentation skill techniques to facilitate successful training. Members of the BCSS will be available for a panel discussion on how this relates to GxP expectations for trained and qualified personnel.

This session will be led by Josephine Scrofani – an ASTD certified trainer who has extensive experience in presenting these sessions for companies and industry.

Course Agenda: 

Welcome & Introduction

The ABC’s of S-P-T

Workshop Overview:

• Speaking – Know Yourself
• Presenting – Know Your Content
• Teaching – Know Your Audience

"Get To Know Each Other"

SPEAKING (S-P-T):

• Vocal Quality & Emphasis
• Non-Verbal Behavior
• Eye Contact & Pauses

SPEAKING SUMMARY

PRESENTING (S-P-T):

• Content Organization
• Road Map Overview

PRESENTING (S-P-T):

• Content: Quality & Quantity
• Visual Aids

TEACHING (S-P-T):

• Adult Learning
• Personal Preferences
• Assessment Techniques
• Classroom Distraction
• Questioning Techniques

TEACHING SUMMARY

S-P-T Final Review

SQA Career Development Map Areas:  New QA - Effective Communication; New QA - Conflict Resolution; Special Topics - Oral Communication; Special Topics - Public Speaking; Special Topics - Personality Interaction; Special Topics - People Management; Special Topics - Dealing with Difficult People 

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6 - Development of Multiple Choice Questions in GCP and GLP 

 ONE DAY: Sunday, 22 April 2011, 8:00 am to 5:00 pm

Member Rates: Complimentary
Nonmember Rates: Complimentary 

Session Chair:  Tiffany Smith PhD, Professional Testing Inc 

Speakers: Vincent Lima, Professional Testing Inc; Tiffany Smith PhD, Professional Testing Inc 

RQAP re-registration units: 2 GCP or 2 GLP

Target Audience: 

This course is intended for QA professionals in GCP or GLP who are registered RQAPs and those with a current or future interest in sitting for an RQAP examination. QA professionals with an interest in test development for their jobs will also find this course of interest. Participants should have at least two years of QA experience. All levels of experience will be challenged by this course. RQAP participants will receive 2 re-registration credits for course participation.

This course will be offered at no cost to participants. A minimum of 10 participants including at least 5 RQAPs is required to conduct this course.

Course Objectives: 

At the end of this workshop, participants shall be able to:

• Describe how tests are developed to be valid and reliable
• Identify common item writing pitfalls
• Write good multiple-choice questions that are ready for review by fellow subject-matter experts

Course Description: 

Have you ever taken an exam and wondered who writes all those questions? Now you can learn the craft of writing excellent multiple choice questions and, if eligible, you can write actual questions for the RQAP program examinations. After an initial instructional seminar, participants will alternate between working individually to write either GLP or GCP questions, and working in groups to critique and improve the questions. The knowledge and skills learned in this session can be applied to the development of test questions for audit-related tasks. You could also be eligible to write additional questions at home for additional RQAP credit.

Course Agenda: 

• Welcome and introductions/Overview of agenda
• Examination construction and item writing overview
• Beverage break
• Breakout sessions according to discipline (GLP/GCP)
• Lunch
• Item writing session
• Beverage break
• Item writing session
• Adjourn

SQA Career Development Map Areas: New QA - GLP; New QA - GCP; Developing QA - GLP; Developing QA - GCP; Mature QA - GLP; Mature QA - GCP 

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7 - From Lab to Market: Getting Regulatory Approval

HALF-DAY: Sunday, 22 April 2012, 8:00 am to 12:00 pm 

Member Rates: $275 through 26 March, $335 after 26 March
Nonmember Rates: $375 through 26 March, $435 after 26 March 

Session Chair:  Martha Bennett RAC, Bennett and Company 

Speakers: Martha Bennett RAC, Bennett and Company; Janet Rose Rea

RQAP re-registration units: 1 GCP or 1 GLP

Target Audience: 

This course is an overview for the QA professional (GLP, GCP, and GMP) who would like an understanding of the path for getting a product approved by FDA or EPA. What types of studies are required? What questions are being asked and answered? Which regulations apply at the different stages?

Course Objectives: 

•  Participants shall be able to describe the steps for regulatory approval.
• Participants shall be able to identify the appropriate regulations that apply to the steps in the process.
• Participants shall be able to name similarities and differences in the process for various types of products.

Course Description: 

 This course will present an overview of the regulatory steps in getting a product approved by FDA or EPA. It will highlight some of the similarities and differences between the FDA’s and EPA’s focus, review process and applicable regulations.

Course Agenda: 

• The Agencies: FDA and EPA
• Early Work: Safety Studies
• The Path Through FDA
• The Path Through EPA
• Questions and Answers

SQA Career Development Map Areas:   

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8 - SQA Leadership Development (for SQA members only)

HALF-DAY: Sunday, 22 April 2012, 1:00 pm to 5:00 pm

Member Rates: Complimentary 

Session Chair: Catherine Bens, USDA-NWRC 

Speakers: James A Ault RAC, RQAP-GLP; Catherine Bens, USDA-NWRC; Kimberly S Frazier MS, Pfizer Inc; Nancy J Gongliewski, GlaxoSmithKline; Elliott Graham RQAP-GLP, Society of Quality Assurance; Michelle A Trapani RQAP-GLP, Novartis Pharmaceuticals Corporation 

RQAP re-registration units: 1 non-GCP or 1 non-GLP

Target Audience: 

This course is directed toward SQA members who wish to become further involved with SQA in a leadership capacity or are considering becoming a future SQA leaderor wish to further develop or gain knowledge of leadership skills.

Course Objectives: 

SQA is an organization made of volunteers. Leadership in SQA is voluntary and requires leadership skills directed toward motivating volunteers. Participants in this course will be able to:

1. Describe how to attract appropriate volunteers and how to get them actively involved
2. Discuss methods of motivating and rewarding volunteers
3. Describe how various leadership activities are linked to the SQA strategic plan
4. Implement effective leadership transition (when leaving a leadership position) so that progress can continue
5. Demonstrate practical and effective communication techniques
6. Identify who to ask for help with SQA leadership activities
7. Use the SQA website to effectively lead and manage committees, specialty sections and/or other ad hoc groups and subcommittees within SQA
8. Use SQA Headquarters services to minimize workload and maximize results
    

Course Description: 

The SQA Board of Directors has created this course for SQA members. This course is designed to provide SQA members with tools and skills that will enable them to be better leaders in both SQA volunteer leadership positions as well as in other areas of their lives. It will provide a better understanding of SQA leadership responsibilities and an understanding of how SQA is governed. SQA members who are considering running for election or volunteering on Committees or within Specialty Sections will gain a better understanding of the requirements and responsibilities of the positions and the resources and assistance SQA offers to support those positions;. It will also provide an opportunity to meet and network with past, current and future SQA leaders and to develop and discuss leadership concepts through fun group exercises.

Course Agenda: 

INTRODUCTION

1. Why
2. What
3. How (exercises)
4. If (panel)

VOLUNTEERISM

1. Volunteers: what are they and why are they important
2. Finding appropriate volunteers
3. Why volunteer – WIIFM
4. Motivating and empowering volunteers

LEADERSHIP SKILLS

1. Leading long-distance committees
2. Goal planning
3. Determining and retaining members
4. How to inspire, delegate, motivate, assign tasks, follow-up on tasks
5. Fine art of delegation
6. Transition of volunteers/chair
7. Evaluating how you are doing
8. Thank you notes

ADMINISTRATIVE SKILLS AND TOOLS

1. Aligning with the SQA Strategic Plan
2. Minutes and reports
3. Website use
4. SQA conference lines
5. Maintaining membership list (Volunteer Commitment Form)

CURRENT LEADER PANEL/Q & A
(5 min personal story from panelists)

RESOURCES

1. URLs/references
2. Non-copyrighted material

SQA Career Development Map Areas: New QA - Effective Communication; Developing QA - People Management; Developing QA - Teamwork; Special Topics - Oral Communication; Special Topics - Written Communication; Special Topics - Leadership Skills 

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9 - Archiving 101: What You Need to Know About GLP-Compliant Archives

HALF-DAY: Monday, 23 April 2012, 1:00 pm to 5:00 pm 

Member Rates: $275 through 26 March, $335 after 26 March
Nonmember Rates: $375 through 26 March, $435 after 26 March 

Session Chair:  Deborah K Yackle, Allergan Inc 

Speakers: Cheryl E Allman RQAP-GLP, EPL Archives; Rémy Engerran, Pfizer Inc; Katherine M Hartney, EPL Archives; Susan L Meeker CQA, RQAP-GLP, Azure Lane Consulting LLC; Deborah K Yackle, Allergan Inc 

RQAP re-registration units: 1 GLP or 1 non-GCP

Target Audience: 

This course would be aimed at new GLP auditors or those newly responsible for establishing and/or maintaining a GLP archive.

Course Objectives: 

The participant shall be able to:

• List the items that need to be archived for a study
• Audit an archive for GLP compliance
• Outline a plan for establishing a GLP compliant archive  

Course Description: 

 Archiving has gained attention recently as more diverse data types are being generated by scientists and more 483s are issued by the agency. This course answers the who, what, when, where, why, & how of archiving.

Course Agenda: 

• Welcome & Introductions
• The who, what, when, where, why, and how of archiving
• The Archive – more than just a place to “store my stuff”
• Beverage break
• We’re out of room! Let’s send it off-site- using commercial archives in a regulated environment
• My archive is moving. What should I do and expect?

SQA Career Development Map Areas:  New QA - GLP 

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10 - Current Trends in cGMP

ONE DAY: Monday, 23 April 2012, 8:00 am to 5:00 pm 

Member Rates: $495 through 26 March, $555 after 26 March
Nonmember Rates: $645 through 26 March, $705 after 26 March 

Session Chair:  Martha Bennett RAC, Bennett and Company 

Speakers: Martha Bennett RAC, Bennett and Company; Janet Rose Rea

RQAP re-registration units: 2 non-GCP or 2 non-GLP

Target Audience: 

This course is designed for mid to senior level quality professionals who are interested in current FDA interpretation and application of CGMPs in the pharmaceutical and medical device industries.

Course Objectives: 

• Understand design control requirements.
• Understand current FDA interpretation of CGMPs throughout product life cycle (research, preclinical, clinical, and post-approval).
• Understand quality systems approach to CGMP requirements.
• Understand qualification and validation requirements throughout product life cycle.
• Understand current FDA enforcement initiative.

Course Description: 

The course will be presented according to the quality systems approach currently used during FDA inspections and will cover the following topics: CGMP nomenclature, similarities and differences between drugs and devices, CGMP relationship to other international quality systems; CGMP elements (design controls, organization and personnel, facilities, equipment, components, production, laboratory, documentation and records); qualification and validation; current FDA enforcement policies. 

Course Agenda: 

 The course will be divided into 4 modules:

I.  CGMP Summary (nomenclature, similarities and differences between drugs and devices, relationship to other international quality systems; current FDA enforcement policy)
II. – III.  Presentation and discussion of CGMP elements (design controls, organization and personnel, facilities, equipment, components, production, laboratory, documentation and records)
IV.  Qualification and Validation

SQA Career Development Map Areas:   

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11 - Process Mapping to Increase Auditing Quality and Effectiveness

ONE DAY: Monday, 23 April 2012, 8:00 am to 5:00 pm 

Member Rates: $495 through 26 March, $555 after 26 March
Nonmember Rates: $645 through 26 March, $705 after 26 March 

Session Chair:  Beth A Galt, MPI Research 

Speakers: Donna M Aliyetti, MedImmune; JoAnn Boyd, Southwest Research Institute; Beth A Galt, MPI Research; Klaus A Goodwin-Pfister, PAREXEL International Inc 

RQAP re-registration units: 2 non-GCP or 2 non-GLP

Target Audience: 

This course is designed for those new to Process Mapping in a GxP environment. This course will benefit anyone from authors, reviewers, or those who simply follow Standard Operating Procedures; to individuals responsible for process planning and quality improvements. The purpose of the course is to provide information on how to develop process maps and how to apply this tool to audits and inspections.

Course Objectives: 

• The attendee shall gain a better understanding of the benefits and how to use process maps.
• The attendee shall be able to create workflow, swim lane, and Suppliers – Inputs – Process – Outputs – Customers (SIPOC) maps.
• The attendee shall gain knowledge of how to analyze, evaluate, and validate processes.
• The attendee will practice and learn how to apply the knowledge to audits and inspections

Course Description: 

This course will cover the steps to identify and map processes. Included will be training on ‘how’ and ‘why ‘ to map processes for work flows and for understanding the purpose and scope of a process through SIPOC mapping. Additional discussion of analysis, evaluation, and validation of processes using process maps will be provided.

Hands-on interactive activities/exercises are planned. Activities will allow use for audits and inspections.

Course Agenda: 

• Defining processes
• Benefits of process mapping
• Steps to map a process
• Understanding types of process maps
  • Workflow
  • Swim lane
  • SIPOC
   
• Create a workflow map
• Create a swim lane map
• Create a SIPOC map
• Use the process map to analyze, evaluate, and validate a process
• Using the process map in application with audits and inspections

SQA Career Development Map Areas:  Developing QA - Advanced Technical Education; Mature QA - Enterprise QA; Special Topics - Quality Systems 

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12 - Improving the Impact of Quality Assurance: Value-Adding Strategies for the 21st Century

ONE DAY: Monday, 23 April 2012, 8:00 am to 5:00 pm 

Member Rates: $495 through 26 March, $555 after 26 March
Nonmember Rates: $645 through 26 March, $705 after 26 March 

Session Chair:  Rita Hattemer-Apostel, Verdandi AG 

Speakers: Krystyjana K Dwyer, PharmaNet/i3; Rita Hattemer-Apostel, Verdandi AG; Anthony B Jones, PharmaNet/i3 

RQAP re-registration units: 2 GCP or 2 GLP

Target Audience: 

This course is intended for QA professionals of all GXP specialties and level of experience. 

Course Objectives: 

After completion of this session the participant shall have:

1. A clear vision of where they are in their career, where they want to be in the future, and a strategy for getting there.
2. A selection of new tools and techniques for achieving quality outcomes and building an effective QA function.
3. Identified activities that will provide the key to future professional and personal development.
4. Identified impediments to development with a plan to reduce or discontinue these.

Course Description: 

 The course provides an opportunity for the QA auditor to improve awareness and to develop talents to enhance the effectiveness of the own activities and interactions in QA with peers, colleagues and auditees. Concepts and ideas originating from psychology, cybernetics, system dynamics and management are introduced to provide a deeper understanding of the nature of QA and how to develop and refine QA competence beyond the training of GXP regulatory requirements. Primary topics of the course are:

• Personal and professional development
• Strategies for personal and professional development
• Improving the impact of Quality Assurance through reviewing techniques to improve effectiveness and focus on maximum value
• Improving efficiency, getting better results with less resource

The course will consist of short presentations/briefings and discussions/case studies/workshops where participants are invited to contribute.

Course Agenda: 

1. Establishing Foundations: perspective of the QA Auditor
   a. Motivation to work in a QA profession
   b. Understanding of the own role
   c. Essence of QA
   d. Core activities performed by QA auditors
2. Building influence: expanding from QA Auditor to peers
   a. Internal QA team, QA organization and QA management
   b. Organizing / prioritizing own QA activities
   c. How does a QA team need to work to be value-adding to an organization
3. Building QA: development opportunities for QA
   a. Lateral vs. vertical career
   b. Useful training and development routes
   c. Interesting literature from management, system dynamics, psychology, organizational learning etc.
4. Engaging to add value: relationship with auditees (internal / external)
   a. Interaction and communication with auditees
   b. Interview techniques
   c. Does and Don’ts
   d. Closing audits and keeping momentum
5. Engaging for impact: defining and concentrating on those activities that will have the large impact professionally and personally.
    

SQA Career Development Map Areas:  New QA - Effective Communication; New QA - Teamwork; New QA - Conflict Resolution; Developing QA - People Management; Developing QA - Teamwork Dynamics; Mature QA - Running a QA Function; Mature QA - Enterprise QA; Special Topics - Oral Communication; Special Topics - Written Communication; Special Topics - Writing Good Findings; Special Topics - Personality Interaction; Special Topics - People Management; Special Topics - Dealing with Difficult People; Special Topics - Stress Management; Special Topics - Career Change 

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13 - Current Topics in Good Laboratory Practice 

ONE DAY: Friday, 27 April 2012, 8:00 am to 5:00 pm

Member Rates: $495 through 26 March, $555 after 26 March
Nonmember Rates: $645 through 26 March, $705 after 26 March 

Session Chairs: Melinda B Apgar RQAP-GLP, Millennium: The Takeda Oncology Company; Matthew A Foster RQAP-GLP, MPI Research 

Speakers: Melinda B Apgar RQAP-GLP, Millennium: The Takeda Oncology Company; Matthew A Foster RQAP-GLP, MPI Research; Joseph A Franchetti, JAF Consulting Inc; Gregory P Furrow, WIL Research Company; Patricia M Miller, PRA International; Frank P Moschetto, Roche; Martin Paton, Millennium: The Takeda Oncology Company; Shari L Perlstein, Pfizer Inc; Joseph P Whittemore, Pfizer Inc 

RQAP re-registration units: 2 GLP or 2 non-GCP

Target Audience: 

Quality Assurance professionals with two or more years of auditing experience in the GLP environment.

Course Objectives: 

1. The participant shall be able to expand on existing knowledge of the GLP regulations to improve auditing and interpretation skills.
2. The participant will participate in round table discussions of GLP Case Studies.
3. The participant shall gain insight into the current topics of bioanalysis and electronic records. 

Course Description: 

With a basic knowledge of the GLPs in your auditing toolbox, it is time to move to the next level. This one-day session will focus on a deeper understanding of the history of the FDA, EPA, and OECD regulations as they pertain to evolving expectations and industry standards. The session will take an interactive approach to understanding the regulations including analysis of GLP Case Studies. This session is intended for QA professionals with 2 years or more of GLP experience.

Course Agenda: 

TBD based on specific topics and speakers.

SQA Career Development Map Areas: Developing QA - GLP; Developing QA - People Management; Developing QA - Regulatory Interpretation; Developing QA - Differences in QA Environments; Developing QA - Specific Job Tasks; Mature QA - GLP; Mature QA - Regulatory Interaction; Mature QA - Enterprise QA; Mature QA - Specific Job Tasks 

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14 - Good Clinical Practice: Beyond the Basics 

ONE DAY: Friday, 27 April 2012, 8:00 am to 5:00 pm

Member Rates: $495 through 26 March, $555 after 26 March
Nonmember Rates: $645 through 26 March, $705 after 26 March 

Session Chairs: Cheryl M McCarthy CQA, Eliassen Group, eClinical Solutions Division; Lee Truax-Bellows RQAP-GCP, Norwich Clinical Research Associates Ltd 

Speakers: Paula Hamilton, GCA Quality Solutions Inc; Cynthia Kleppinger, US Food and Drug Administration; Cheryl M McCarthy CQA, Eliassen Group, eClinical Solutions Division; Jean Toth-Allen, US Food and Drug Administration; Lee Truax-Bellows RQAP-GCP, Norwich Clinical Research Associates Ltd 

RQAP re-registration units: 2 GCP or 2 non-GLP

Target Audience: 

GCP auditors with 3 or more years of experience

Course Objectives: 

1. The attendee shall be able to understand the impact of Global GCP requirements for QA Professionals (FDA/Regulatory Rep to present)
2. The attendee shall be able to incorporate presented professional development , audit and training techniques into their roles
3. The attendee shall be able to understand the current status of Regulations that impact GCP (FDA/Regulatory Rep to present)

Course Description: 

This interactive session will provide experienced GCP QA professionals with additional tools to incorporate into how they perform audits, training and GCP support within their roles. This session has been designed to provide best practices and audience participation activities that highlight the experience of the presenters and the attendees. In addition to these topics, this session will also provide the regulatory perspective as it relates to the current status of GCPs as experienced in the global community.

Course Agenda: 

Topics to be covered include:

• Auditing – Advanced tools and techniques in the auditors toolbox
• Quality System Approach to the Conduct of Clinical Trials
• Regulatory and Guidance Updates
• How International Regulations and GCPs relate to US standards

SQA Career Development Map Areas: Developing QA - GCP; Developing QA - Intro to Risk Management; Developing QA - Regulatory Interpretation; Developing QA - Teamwork; Developing QA - Understanding Differences in QA Environments; Mature QA - GCP; Mature QA - Regulatory Interaction; Mature QA - Running a QA Function; Mature QA - Enterprise QA; Mature QA - Advanced Risk Management 

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15 - Good Practices: Understanding the GxP Regulations Using a Quality System Approach

ONE DAY: Friday, 27 April 2012, 8:00 am to 5:00 pm 

Member Rates: $495 through 26 March, $555 after 26 March
Nonmember Rates: $645 through 26 March, $705 after 26 March 

Session Chair:  Melissa M Eitzen MS, RQAP-GLP, University of Texas Medical Branch 

Speakers: James A Ault RAC, RQAP-GLP; Melissa M Eitzen MS, RQAP-GLP, University of Texas Medical Branch; Gregory P Furrow, WIL Research Company; Eric Humes RQAP-GLP, ICON Development Solutions; Janet Rose Rea

RQAP re-registration units: 2 GCP or 2 GLP

Target Audience: 

This course is suitable for all QA professionals. Novice auditors will gain knowledge of the ‘big picture’ of the entire regulated process while also learning important terminology. Seasoned QA professionals who specialize in one area of the GxPs will gain an understanding of other areas.

Course Objectives: 

The attendee shall be able to:

• Use Quality System principles to understand specialty areas outside their scope of expertise
• Recognize commonalities and regulation overlaps between specialty areas
• Understand differences in terminology used within specialty areas
• Increase communication skills between QA and Regulatory Affairs
• Apply Quality System elements to complex areas to reduce compliance risk

Course Description: 

 This course is designed to broaden/promote a better understanding of the various GxP regulations among QA professionals in order to expand knowledge and improve communication among SQA members, sponsors, regulatory agencies, and CROs.  Originally titled “Understanding GxPs:  Bridging the Communication Gap,” the course content has been revised to view each set of GxP regulations from a Quality System perspective.  The panel of expert speakers will use the basic principles of Quality Systems as defined in GLP, GCP (human and veterinary), and GMP to understand complex areas such as GLP efficacy studies, laboratory assays conducted under Good Clinical Laboratory Practices, and documentation standards for late discovery studies.  Additional course sessions include an overview of the regulatory pathway, Regulatory Affairs, and understanding the applicability of corrective action programs across all of the GxP regulations.  Attendees will test their knowledge by participating in case study discussions. A Question and Answer Panel session is included to promote open discussions with attendees. 

Course Agenda: 

• Welcome/Introduction
• Overview of the Regulatory Pathway
• Communicating with Regulatory Affairs
• GLP as a Quality System
• Expanding the GLP Quality System to GCLP
• hGCP as a Quality System
• Applying Quality Components of the hGCPs to GCLP
• vGCP as a Quality System
• Q&A
• GLP & GCP: Combing Quality Systems for Animal Efficacy Studies
• GMP as a Quality System & Medical Devices
• Test Your Knowledge: Case Studies
• Applying GLP as a Quality System to late Discovery Studies
• CAPA Systems & Root Cause Analysis across all GxPs
• Q&A Panel Discussion

SQA Career Development Map Areas:  New QA - Basic Regulatory Process; New QA - Science vs. QA; Developing QA - GLP; Developing QA - Regulatory Interpretation; Developing QA - Understanding differences in QA environments; Mature QA - Regulatory Interaction; Mature QA - Enterprise QA; Special Topics - Oral Communication; Special Topics - Quality Systems 

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16 -  Common Challenges in Non-Clinical Medical Device Compliance

ONE DAY: Friday, 27 April 2012, 8:00 am to 5:00 pm 

Member Rates: $495 through 26 March, $555 after 26 March
Nonmember Rates: $645 through 26 March, $705 after 26 March 

Session Chair:  Cynthia R Ivey MS, RQAP-GLP, Surpass Inc 

Speakers: Debra A Bridges RVT, RQAP-GLP, Texas A&M Institute for Preclinical Studies; LaDonna J Camrud RQAP-GLP, Medtronic Inc; Linda Palagi Lynn MS, RQAP-GLP, LPL Quality Services Inc 

RQAP re-registration units: 2 GLP or 2 non-GCP

Target Audience: 

GLP professionals with 1 or more years experience in the medical device industry. QA professionals with 2 or more years experience.

Course Objectives: 

Participants in this training session will:

• Gain a better understanding of the current GLP medical device regulatory climate
• Receive insight into industry application of the Cardiovascular Device Guidance Document
• Learn tips and tools for auditing electronic data
• Approach test and control article characterization with new insight

Course Description: 

GLP medical device industry professionals are consistently challenged with innovations in medical device technology and regulatory expectations. This one-day session is devoted to addressing today’s medical device compliance climate and providing tools relevant to the complexities facing non-clinical device professionals.

Course Agenda: 

• Industry Challenges in Conducting Medical Device Studies
• Practical Application of the Cardiovascular Device Guidance Document – An Industry Perspective
• Agency Expectations for Veterinary Care, Animal Observations, and Beyond
• Tips for Auditing Electronic Data
  - Spreadsheets
  - Commercial Systems
  - Archiving
• Medical Device Test and Control Article Characterization
  - Common medical devices
  - Non-standard medical devices
  - Combination products

SQA Career Development Map Areas:  Developing QA - GLP; Developing QA - Advanced Technical Education; Developing QA - Regulatory Interpretation; Developing QA - Specific Job Tasks 

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17 - Continual Quality Improvement: Expanding the QA Toolbox

ONE DAY: Friday, 27 April 2012, 8:00 am to 5:00 pm 

Member Rates: $495 through 26 March, $555 after 26 March
Nonmember Rates: $645 through 26 March, $705 after 26 March 

Session Chair:  Catherine Bens, USDA-NWRC; JoAnn Boyd, Southwest Research Institute; Richard M Siconolfi, Procter & Gamble Co 

Speakers: Catherine Bens, USDA-NWRC; JoAnn Boyd, Southwest Research Institute; Richard M Siconolfi, Procter & Gamble Co 

RQAP re-registration units: 2 GCP or 2 GLP

Target Audience: 

QA managers, auditors, test facility managers, regulatory affair managers

Course Objectives: 

1. Introduce the concept of Continuous Improvement and the benefits of such a program for GxP facilities, activities, studies, etc.
2. Review some key tools that have been highly successful in quality improvement
3. Present these tools in enough detail including actual applications and engaging in interactive exercises that will participants to use these tools in their own work environment.

Course Description: 

This course will provide an overview of recognized quality management tools that have been successfully deployed in business management today. The Research QA profession as a whole has not historically utilized these tools and QA professionals may have little to no formal training in continuous improvement methods to be aware of their value in assessing and improving the impact and value of the QAU to any organization. This course will review basic problem solving and statistical tools used in systematic approaches to continuous improvement programs. Emphasis will be on value-added assessments and in learning quality concepts, principles and practices of the fundamental tools. Participants will learn how to determine which tool to use for which situation and participate in problem solving exercises using the tools. In-depth presentations on a number of fundamental tools will be provided which may include:

The Plan-Do-Check-Action Cycle
Quality Circles
Quality Control Charts and Trending Analysis
Pareto Charts
Fish-bone Diagrams
Hands-on-Workshop

Each tool will be presented as an interactive module which will include a detailed description of the tool, its history in the business world, its strengths and weaknesses and appropriate application, and examples of its use in the quality system. Extended opportunity to work with each tool and discuss its applications will be provided through small group activities and exercises.

Course Agenda: 

Presentation provided on how to use the tools for continuous improvement the first four hours. The last four hours of the class will have hands on experience workshop activities that will allow attendees to actually use the tools in a real case study using regulatory findings in GLP, GCP, and GMP areas.

SQA Career Development Map Areas:  New QA - GLP; New QA - GCP; New QA - GMP; New QA - Basic Regulatory Process; New QA - Science vs. QA; New QA - QA vs. QC; New QA - Effective Communication; New QA - Teamwork; New QA - Ethics and Integrity; New QA - Conflict Resolution; New QA - Specific Job Tasks 

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18 - GMP for GCP Auditors

HALF-DAY: Friday, 27 April 2012, 8:00 am to 12:00 pm 

Member Rates: $275 through 26 March, $335 after 26 March
Nonmember Rates: $375 through 26 March, $435 after 26 March 

Session Chair:  Allan Klein PhD, West Chester University 

Speakers: James J Carignan RQAP-GLP, MedImmune; Allan Klein PhD, West Chester University 

RQAP re-registration units: 1 GCP or 1 non-GLP

Target Audience: 

Auditors, managers,  or other regulatory personnel with at least one year of experience in GCP regulations and auditing. 

Course Objectives: 

• Achieve a fundamental understanding of GMP regulations that apply to clinical studies.
• The attendee shall be able to recognize the difference between sufficient and insufficient documentation of a clinical supply.
• The attendee shall be able to understand the interplay between GMP compliance and GCP compliance.
• The attendee shall acquire an understanding of the auditing of GMP operations that support GCP studies.

Course Description: 

This training will provide the GCP auditor with insight into how FDA and EU GMP regulations may impact GCP studies. The class focuses on clinical supply manufacturing, testing, and control performed under FDA GMP compliance requirements for GCP studies. The presentation explores and compares particular aspects of the GMP regulations with the compliance requirements of the GCP regulations. The class also explores potential difficulties encountered in meeting GCP compliance requirements for work performed under GMP regulations, and what GCP auditors need to know to evaluate compliance. 

Course Agenda: 

• Introduction
• Compliance: Assumptions & Definitions
• GCPs and the GMPs: Where they Intersect
• GMPs and How they Impact GCPs
• What We Do in Practice :
• What Should an Auditor Look For?
• Mock Study Case Exercises
• Wrap-Up: Q&A

SQA Career Development Map Areas:  New QA - GMP; New QA - QA vs. QC; Developing QA - GMP; Developing QA - Advanced Technical Education; Developing QA - Regulatory Interpretation; Mature QA - GMP

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