September 2018 Quality College Course Descriptions




1 — GLP 101: Basic Training (2 Days)

Monday, 24 September 2018, 8:00 AM - Tuesday, 25 September 2018, 5:00 PM

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

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 27 August 2018: Member Rate $745, Non-member Rate $895, Student Rate $375
  • After 27 August 2018: Member Rate $805, Non-member Rate $955, Student Rate $405

Description
This course is a comprehensive introduction to FDA Good Laboratory Practice regulations or refresher training for all personnel involved in a nonclinical laboratory study.  The course also provides a review of GLP history, examination of the FDA Preambles, offers topical comparisons between FDA and EPA requirements and OECD Principles, and is intended to equip the participant with a working knowledge of GLP impacts on study conduct.  Opportunities for group interaction and breakout periods help widen the educational exchange while enhancing the learning process.

Objectives
At the end of the course, the participants shall be able to: 
  • Understand the regulatory requirements for nonclinical laboratory facilities, equipment, personnel, methods, practices, records and controls to assure Management of compliance or report the lack thereof;
  • Identify compliance gaps in the overall quality system of a facility and suggest improvements based upon regulatory requirements;
    Effectively communicate the requirements of FDA GLPs and identify topical differences between FDA and EPA requirements and OECD Principles of GLP;
  • Interpret and apply GLP requirements using a variety of resources;
  • Use the knowledge obtained by completing the training exercises to increase effectiveness in current role


Target Audience
This course is a comprehensive introduction to FDA Good Laboratory Practice regulations or refresher training for all personnel involved in a nonclinical laboratory study. 


Agenda
1:  Basic GLP Training Overview
2:  Landmark Cases in the Development of GLP
3:  Organization of the GLP Regulations
4:  Scope and Definitions
5:  Contracting Under GLPs and Inspections of Testing Facilities
6:  Organization and Personnel
7:  Facilities
8:  Equipment
9:  Testing Facilities Operation
10:  Test and Control Articles
11:  The Protocol
12:  Conduct of Nonclinical Laboratory Studies
13:  Reporting of a Nonclinical Laboratory Study
14:  Storage, Retrieval, and Retention
15:  Electronic Record Keeping in Nonclinical Laboratory Studies
16:  Shall vs. Should
17:  FDA/EPA Regulations vs. OECD Principles of GLP
 


2 — **CANCELLED** GCP 102:  An Introduction to Good Clinical Practice (1 Day)

Monday, 24 September 2018, 8:00 AM - 5:00 PM

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

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 27 August 2018: Member Rate $410, Non-member Rate $560, Student Rate $205
  • After 27 August 2018: Member Rate $470, Non-member Rate $620, Student Rate $235

Description
This is a very basic course, ideal for GMP/GLP auditors who wish to broaden their skills and those with less than a year of GCP auditing. 

Objectives
At the end of the course, the participants shall be able to: 
  • Define Good Clinical Practice
  • Find key regulations within 21 CFR (book or handouts to be provided)
  • Describe 34 activities to be performed during a GCP Investigator Site Audit and a Service Provider Audit
  • Understand the importance of subject safety and data integrity


Target Audience

Auditors with no GCP experience up to a maximum of 1 year experience.


Agenda
  • The agenda will be provided separately.


3 — GCP 203: Overcoming the Challenges of Clinical Quality Management in Small Companies and Startups (1/2 Day)

Monday, 24 September 2018, 8:00 AM - 12:00 PM

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

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 27 August 2018: Member Rate $285, Non-member Rate $385, Student Rate $145
  • After 27 August 2018: Member Rate $345, Non-member Rate $445, Student Rate $175


Description
So much to do, so little time. This course will discuss the unique challenges of implementing and maintaining a QMS at a small company or startup. It will provide practical advice and tools to help the participant in improving their own QMS.

Objectives
At the end of the course, the participants shall be able to: 

• Define the challenges of implementing and maintaining Quality Management Systems in small companies
• Develop the right sized processes and procedures
• Understand the role of change management principles in small environment
• Define Quality Metrics that drive continuous compliance and improvement
• Understand the cross functional challenges and using existing GMP/GLP processes for GCP.

Target Audience
This training is ideal for:
Clinical QA professionals working in or supporting QA activities within a small company environment.


Agenda
- Welcome and Introductions
- Challenges of QMS in small companies
- Exercise #1 - Discussion
- Right Sized Processes Presentation
- Role of Change Management
- Exercise #2 - Change Management Techniques
- Quality Metrics
- Exercise #3 - Develop Quality Metrics
- Cross Functional Challenges
- Discussion - use of established GLP/GMP systems for GCP processes


4 — General 104: Three Cs of SOPs: Clear, Concise, and Compliant in a Regulatory Setting (1/2 Day)


Monday, 24 September 2018, 1:00 PM - 5:00 PM

RQAP re-registration units: 1 GCP or GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 27 August 2018: Member Rate $285, Non-member Rate $385, Student Rate $145
  • After 27 August 2018: Member Rate $345, Non-member Rate $445, Student Rate $175

Description
This course will cover the full life-cycle of controlled process documents -- from creation through archival. Topics will also include responsibilities, training, and non-compliance. Attendees should be prepared to bring examples of questions relating to SOPs (controlled process documents) and SOP management.

Objectives
At the end of the course, the participants shall be able to: 
  • Understand the purpose and benefit of effective SOPs.
  • Understand the critical role of SOPs in Quality Documentation systems.
  • How to write a concise, unambiguous SOP for its intended purpose.
  • Define clear responsibilities to promote action and closure within the document.
  • Training requirements.
  • Manage revisions, nonconformance and deviations from a current SOP.
  • Difference between GCP/GLP/GMP with regard to SOPs and how they are
    used.


Target Audience
Anyone responsible for the life cycle and compliance of these key components of the Quality Management System. This course is applicable to GMP, GCP, GLP and GVP -- both beginners and more experienced

Agenda

  • Introduction
  • Understand the Purpose and Benefit of Effective SOPs
  • SOP on SOPs
  • Characteristics of Good SOPs
  • Art to Writing SOP Content
  • Relationship between Plan / Protocol, SOPs, and Data
  • Deviations
  • Awareness / Training
  • Why people don’t use SOPs
  • Wrap up



5 — GCP 201: Advanced Training (1 Day)

Tuesday, 25 September 2018, 8:00 AM - 5:00 PM

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

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 27 August 2018: Member Rate $510, Non-member Rate $660, Student Rate $255
  • After 27 August 2018: Member Rate $570, Non-member Rate $720, Student Rate $285

Description
This interactive session will provide experienced GCP QA professionals with advanced GCP QA 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.

Objectives
At the end of the course, the participants shall be able to: 
  • The attendee shall be able to incorporate presented professional development and advanced audit and training techniques into their roles.
  • The attendee shall be able incorporate current regulations and guidelines that impact GCP into their roles.
  • The attendee shall be able to understand and implement a quality management system approach into their roles.


Target Audience
GCP Professionals with 2 or more years of experience.


Agenda
  • 8:00–8:30: Welcome, Housekeeping, Agenda Review and Introductions Lee Truax-Bellows
  • 8:30–9:15: Components of a Quality Management System (QMS) Glenda Guest
  • 9:15–10:00: FDA’s Approach to a Quality Management System Approach in GCPs
  • 10:00–10:15: Break
  • 10:15–11:00: EU’s Approach to Quality Management System Approach in GCPs Pending Speaker
  • 11:00–12:00: Additional Strategies for Planning, Conducting and Reporting
    Audits Under a QMS Approach Cheryl McCarthy (if available)
  • 12:00–1:00: Lunch
  • 1:00–2:00: Practical Application of a Quality Management System (QMS) Approach Within the GCP Arena, Glenda Guest
  • 2:00–3:00: GCP Risk Management, Lee Truax-Bellows
  • 3:00–3:15: Break
  • 3:15–4:30: Root Cause Analysis and CAPA Under GCPs, Lee Truax-Bellows
  • 4:30–5:00: Q&A All


6 — CSV 201: Auditing Software and Data Providers with a Focus on Cloud Services (1 Day)

Tuesday, 25 September 2018, 8:00 AM - 5:00 PM

RQAP re-registration units: 2 GCP or GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 27 August 2018: Member Rate $510, Non-member Rate $660, Student Rate $255
  • After 27 August 2018: Member Rate $570, Non-member Rate $720, Student Rate $285

Description

By the end of this training, you will have the essential and practical knowledge to and tools for auditing software and data providers.  This session will focus on computerized systems that not only reside locally, but also in the cloud. The session teaches you how to develop audit plans, and focus on the goals of the audit to guide you and your team in the execution of the audit strategy.

Additionally, with the advent and increased use of hosted services (e.g., Cloud Computing), this training will explain strategies for auditing Infrastructure Qualification of SaaS models.


Objectives
At the end of the course, the participants shall be able to: 

  • Establish Vendor Audit strategy for Computing Technology Providers
  • Develop the purpose and goals of a Software or Data Supplier Audit.
  • Organize an Audit team for a Software or Data Provider Audit.
  • Assess business and technology capability for a Supplier
  • Evaluate business and technology risks to your organization
  • Identify and present auditing strategies for Network Infrastructure Qualification
  • Organize and execute an effective Audit for a computerized system, software or data or cloud provider.


Target Audience

This training is ideal for personnel who are new to auditing Software and Data providers but are experienced in auditing.

The training is especially useful for Computer Systems Business Process Owners, Project Managers, Quality Assurance, Internal Audit Groups, Supplier Management, Senior Management, and staff from Information Technology and Security.


Agenda

  • Audit Preparation
  • Audit Execution
    • Introductory Meeting
    • Demo
    • Document Review: SOPs, Staff, & System Deliverables
    • Interviews
    • Wrap-up / Debrief Meeting
    • Audit in absence of Standards and Procedures
  • Audit Report & Follow up



7 — GLP 104: Auditing Techniques (1/2 Day)

Wednesday, 26 September 2018, 8:00 AM - 12:00 PM

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

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

SQA's Basic Training: Good Laboratory Practice (in person or online) is recommended before taking this course, but it is not required.

Prices

  • Before 27 August 2018: Member Rate $285, Non-member Rate $385, Student Rate $145
  • After 27 August 2018: Member Rate $345, Non-member Rate $445, Student Rate $175

Description
This course is a comprehensive introduction to auditing GLP study data, final reports and facility records, utilizing data from a mock in vitro study. The course will incorporate how to effectively communicate and resolve audit observations. Opportunities for group interaction, group exercises, and discussion will help to enhance the learning process.

Objectives
At the end of the course, the participants shall be able to:  

  • Understand the regulatory requirements for GLP QA
  • Understand regulatory inspection process for nonclinical laboratory facilities, including a review of the Bioresearch Monitoring Program (BIMO) Compliance Program Guidance Manual (CPGM)
  • Effectively communicate FDA GLP requirements to management and study personnel
  • Audit laboratory records, electronic data and final reports for compliance with regulations
  • Identify compliance gaps and effectively communicate gaps and recommendations for correction via an audit report
  • Use knowledge and skills obtained through collaborative group exercises to enhance technical proficiency.

Target Audience
This course is a comprehensive introduction or refresher training for all personnel working within a FDA Good Laboratory Practice facility.

 

Agenda
  1. Course Overview
  2. Quality Assurance Responsibilities
  3. CPGM Overview
  4. Protocol Audits
  5. Process and Phase Inspections
  6. Study Data
  7. Report Audits
  8. Developing Audit Observations and Resolving Audits
  9. Quality Assurance Statements
  10. Facility Records



8 — GCP 202: Hot Topics & Industry Trends (1 Day)

Wednesday, 26 September 2018, 8:00 AM - 5:00 PM

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

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 27 August 2018: Member Rate $510, Non-member Rate $660, Student Rate $255
  • After 27 August 2018: Member Rate $570, Non-member Rate $720, Student Rate $285

Description

This interactive workshop will bring together several subject matter experts to explore hot topics and industry trends in addressing current challenges in the GCP environment. This is a highly interactive workshop with interactive group exercises to help you apply the concepts covered during brief lectures and discussions. Late breaking GCP topics may be added as applicable.

Objectives
At the end of the course, the participants shall be able to: 
  • Describe how Block Chain technology may impact the future of clinical research.
  • Identify 3 FDA recommended techniques for optimizing protocol and data collection tools.
  • Implement more effective interview techniques.
  • Discuss benefits of data mapping with regard to eSource Guidance and source data verification activities.
  • Define and understand KPI/KRI/QTLs


Target Audience

GCP Professionals with 2 or more years of experience.


Agenda
  • Welcome and Introductions
  • eSource Guidance
  • Protocol and Data Optimization
  • Data Mapping
  • Block Chain Technology
  • Effective Interview Techniques
  • FDA Update (topic of their choosing)
  • Key Performance Indicators (KPI)/Key Risk Indicators (KRI)/Quality Tolerance Limits (QTL)


9 — **CANCELLED** General 202: Product Development Audits and Inspections (1/2 Day)

Wednesday, 26 September 2018, 8:00 AM - 12:00 PM

RQAP re-registration units: 1 GCP or GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 27 August 2018: Member Rate $285, Non-member Rate $385, Student Rate $145
  • After 27 August 2018: Member Rate $345, Non-member Rate $445, Student Rate $175

Description
Course will provide an understanding of the key components of a successful product development audit program. Course will cover internal and vendor audits. Course will include a review of US FDA Bioresearch Monitoring Inspection Programs, focusing on sponsor and investigator inspections.

Objectives
At the end of the course, the participants shall be able to:  

  • Define & Compare Audits and Inspections
  • Review US FDA Inspections
  • Review Quality Audit Program Model
  • Exercise: Develop Inspection Readiness & Audit Plans

Target Audience
Quality Professionals and Managers with responsibility for hosting FDA Bioresearch Monitoring (BIMO) inspections.  Also, Subject Matter Experts who would participate in FDA BIMO inspections.

 

Agenda
  1. Audits & Inspections - similarities & differences
  2. US FDA Bioresearch Monitoring Program
  3. FDA Sponsor Inspections
  4. FDA Investigator Inspections
  5. Inspection Readiness
  6. FDA Inspection Exercise
    15 min break
  7.  Key components of successful audit programs
  8.  Internal Product Development Audits
  9. Exercise - define the audit universe & plan
  10. Supplier Audit Program overview
  11. Supplier Life cycle management
  12. Quality Agreements
  13. Exercise - Supplier Risk Assessment
  14. Recap & closing


10 — General 203: Business Continuity and Disaster Recovery (1/2 Day)

Wednesday, 26 September 2018, 8:00 AM - 12:00 PM

RQAP re-registration units: 1 GCP or GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 27 August 2018: Member Rate $285, Non-member Rate $385, Student Rate $145
  • After 27 August 2018: Member Rate $345, Non-member Rate $445, Student Rate $175

Description

By the end of this training, you will have the essential and practical knowledge and tools for creating and effective, comprehensive, and reliable Business Continuity and Disaster Recovery Plans for your organization. The session will also discuss the auditing techniques for the quality professional to effectively audit the plans as well as suppliers to the process.  The session teaches you how to develop Business Continuity and IT Disaster Recovery Plans which comply with the industry's best practices and standards. Participants will have hands-on exercises performing table top scenarios that will help them leverage their learning’s. 


Objectives
At the end of the course, the participants shall be able to: 
    • Establish BC Program lifecycle processes within your organization.
    • Assess business and technology requirements for a BC Plan.
    • Evaluate Business Continuity risks to your organization.
    • Organize an effective BC team.
    • Develop a BC Plan document.
    • Coordinate a BC Plan with external entities.
    • Develop an effective test plan for testing the BC Plan.
    • Organize and conduct successful BC Plan tests.
    • Establish a process for maintaining the BC Plan.
    • Implement a BC Plan change management process.
    • Avoid typical mistakes that lead to BC Program failures.
    • Understand the main differences between a Disaster Recovery Plan, Emergency Response Plan, Crisis Management Plan, and Business Continuity Plan.

      Target Audience

      This training is ideal for personnel that:

      • Are new to the concept of disaster recovery (DR) and business continuity (BC) and need to develop a DR and/or BC Plan.
      • Need to validate or improve an existing BC Plan for your organization.
      • Have been assigned to lead or be a part of a Business Continuity Program team for your organization.
      • Are responsible for preparing a DR Plan for your IT systems, network infrastructure and data centers.
      • Plan to offer professional consulting services for BC and DR.
      • Need to ensure your BC Plan meets the requirement for internal or external audits.
      • Need to expand your current area of expertise to BC.

      The training is especially useful for Business Continuity and Disaster Recovery Planners, Business Unit Managers, Project Managers, Quality Assurance, Senior Management, and staff from Information Technology, Security, Emergency Response and Crisis Management, Communications, Facilities, Operations Management and Human Resource Departments.


      Agenda

      Define Business Continuity & Disaster Recovery, Define Phases of Business Continuity, Develop a governing process including Quality Assurance oversight and Provide Lessons Learned


      11 — GLP 102: Lies, Deceit, and Drift: The Creation of the FDA GLPs and Why They Are Still Relevant Today (1/2 Day)
      **Course formerly known as History Behind the FDA GLPs**

      Wednesday, 26 September 2018, 1:00 PM - 5:00 PM

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

      *Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

      Prices

      • Before 27 August 2018: Member Rate $285, Non-member Rate $385, Student Rate $145
      • After 27 August 2018: Member Rate $345, Non-member Rate $445, Student Rate $175

      Description

      This training teaches the history behind the GLPs, why they were written as they were, and how to apply them in today's environment. The fraud uncovered by the FDA was astounding, and led to the creation of the GLPs. Have you heard of the magic pencil study or the swamp? Did you know that tissue masses were removed from live animals to 'take a look to see what was inside'? This presents GLP training in a novel way, by linking fraud to regulations to SOPs to the FDA Compliance Program Guidance Manual to recent 483s. 


      Objectives
      At the end of the course, the participants shall be able to: 
        • Learn the history behind the FDA GLP regulations
        • Learn the correlation between the initial fraud, regulations, and CPGM
        • Learn how to apply the GLPs to situations at their local labs
        • Understand how to apply history learnings to write better findings.

          Target Audience
          Anyone interested in understanding why the FDA GLP regulations were written and how they can be applied, spans from beginner to experienced professionals.

          Agenda

          • History prior to 1970s
          • Searle Pharmaceutical, Searle Task Force
          • Industrial Bio-Test Lab
          • Monsanto
          • Hazleton Lab
          • Congressional hearing, Bressler Report
          • Regulatory action, IBT Trial
          • Practical exercises to write robust audit findings by applying history learnings to specific situations


          12 — **CANCELLED** General 105: Bias Control: Protecting Us from Ourselves (1/2 Day)

          Wednesday, 26 September 2018, 1:00 PM - 5:00 PM

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

          *Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

          Prices

          • Before 27 August 2018: Member Rate $285, Non-member Rate $385, Student Rate $145
          • After 27 August 2018: Member Rate $345, Non-member Rate $445, Student Rate $175

          Description
          Not too long ago, Francis Bacon issued his philosophical work entitled, Novum Organum Scientiarum (‘new instrument of science’), that continued our understanding about the scientific method by focusing on empirical investigation. He noted that as humans we are programmed to pay more attention to evidence that agrees with our preconceptions and to reject evidence that doesn’t. If we want to learn more about the universe, we needed to take this inherent tendency toward natural bias into consideration in the design of scientific experimentation
          and focus on empirical investigation. It’s been 400 years since Novum Organum and we still struggle with preventing non-random error from influencing research planning, conduct, analysis and reporting. This course will explore potential sources of error and bias in experimental research. We will review some of the real dangers of research bias through case studies and examples and go over some of the techniques used to control or limit bias in research.

          Objectives
          At the end of the course, the participants shall be able to:  
          • Define experimental error and bias.
          • Explain the different types of bias that may affect experimental research and provide examples.
          • Describe the dangers in not controlling for research error and bias.
          • Describe techniques we can use to control or limit bias in research

          Target Audience
          Managers, SD/PI, QA/QC and those responsible for study design and QA.

           

          Agenda
          1. Introduction
          2. Definitions – What is Bias?
          3. Random (non-systematic) versus Non-random (Bias) Error
          4. Types of Research Bias
          5. When can error occur in research?
          6. Classification and examples in the GXP data life cycle – Selection, Information and Confounding bias
          7. Error and Bias Impacts on data
          8. Positive/negative error
          9. Towards or away from the null
          10. Controlling from Bias
          11. Reducing error
          12. Detailed examples of tools (e.g., blinding, randomization, interobserver reliability testing, sample size selection, etc)
          13. Bias in Quality Assurance Activities
          14. Case Studies and Discussion