September 2016 Quality College Course Descriptions




1 — History Behind the FDA GLPs (1/2 Day)

Tuesday, 27 September 2016, 8:00 AM - 12:00 PM

RQAP re-registration units: 1.00 GLP/non-GCP

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

Prices

  • Before 29 August 2016: Member Rate $285, Non-member Rate $385
  • After 29 August 2016: Member Rate $345, Non-member Rate $445

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
This course is for 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


2 — Good Clinical Practice: The Basics (1 and 1/2 Days)

Tuesday, 27 September 2016, 8:00 AM - 5:00 PM Wednesday, 28 September 2016, 8:00 AM - 12:00 PM

RQAP re-registration units: 3.00 GCP/non-GLP

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

Prices

  • Before 29 August 2016: Member Rate $560, Non-member Rate $710
  • After 29 August 2016: Member Rate $620, Non-member Rate $770

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

Objectives
At the end of the course, the participants shall be able to: 
  • Define Good Clinical Practice
  • Cite key events impacting the evolution of GCP
  • Find key regulations within 21 Code of Federal Regulations (book to be provided)
  • Describe 3-4 Activities to be done during the audit


Target Audience
Auditors with less than 1 year GCP experience. This is a basic course. 


Agenda
  • The agenda will be provided separately.


4 — Business Continuity and Disaster Recovery (1/2 Day)

Tuesday, 27 September 2016, 1:00 - 5:00 PM

RQAP re-registration units: 1.00 GCP/GLP

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

Prices

  • Before 29 August 2016: Member Rate $285, Non-member Rate $385
  • After 29 August 2016: Member Rate $345, Non-member Rate $445

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
  • Identify and select cost-effective BC recovery strategies
  • 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 the following: Business Continuity & Disaster Recovery Planners, Business Unit Managers, Project Managers, QA, Senior Management, and staff from IT, Security, Emergency Response & Crisis Management, Communications, Facilities, Operations Management and HR Departments

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


5 — Basic Good Laboratory Practice (2 Days)

Wednesday, 28 September 2016, 8:00 AM - 5:00 PM Thursday, 29 September 2016, 8:00 AM - 5:00 PM

RQAP re-registration units: 4.00 GLP/non-GCP

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

Prices

  • Before 29 August 2016: Member Rate $745, Non-member Rate $895
  • After 29 August 2016: Member Rate $805, Non-member Rate $955

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
  • Basic GLP Training Overview
  • Landmark Cases in the Development of GLP
  • Organization of the GLP Regulations
  • Scope and Definitions
  • Contracting Under GLPs and Inspections of Testing Facilities
  • Organization and Personnel
  • Facilities
  • Equipment
  • Testing Facilities Operation
  • Test and Control Articles
  • The Protocol
  • Conduct of Nonclinical Laboratory Studies
  • Reporting of a Nonclinical Laboratory Study
  • Storage, Retrieval, and Retention
  • Electronic Record Keeping in Nonclinical Laboratory Studies
  • Shall vs. Should
  • FDA/EPA Regulations vs. OECD Principles of GLP.


6 — Auditing Software and Data Providers with a focus on Cloud Services (1 Day)

Wednesday, 28 September 2016, 8:00 AM - 5:00 PM

RQAP re-registration units: 2.00 GCP/GLP

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

Prices

  • Before 29 August 2016: Member Rate $510, Non-member Rate $660
  • After 29 August 2016: Member Rate $570, Non-member Rate $720

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 clouds. 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 the overuse of the term “Cloud Computing” and the similarities and differences in auditing Contract Data Center/Host Service sites.

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
  • Organize and execute an effective Audit for a computerized system, software or data or cloud provider
  • Examine suggested approaches for conducting and reporting vendor audits


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 — CAPA Day One: Problem Definition - Beyond Human Error (1 Day)

Wednesday, 28 September 2016, 8:00 AM - 5:00 PM

RQAP re-registration units: 2.00 GCP/GLP

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

Prices

  • Before 29 August 2016: Member Rate $510, Non-member Rate $660
  • After 29 August 2016: Member Rate $570, Non-member Rate $720

Description
Fundamental to an effective CAPA program is the practical application of Root Cause Analysis (RCA) and developing an understanding of the root cause(s), contributing cause(s), and possible cause(s) of the issue/problem. Defining the problem – setting boundaries – is integral to enabling an effective RCA. This course will provide tools, insight and best practice to support continuous process improvement and enable sustained results by emphasizing approaches to defining the problem and analyzing the causal factors. A common deficiency in many Industry CAPA programs is a myopic RCA identifying human error and solely prescribing training as the preventive mitigation. By going beyond human error and training, the effective CAPA program becomes a systematic assessment, focusing less on the individual and more on the process(es) in place (What about the process that allowed the issue to occur?) and the process quality control (What about the process that allowed the issue not to be detected?).

Objectives
At the end of the course, the participants shall be able to: 
  • Understand the difference between reactive and proactive
  • Understand the advantage of a systematic methodology
  • Know what is a CAPA?
  • Define a problem (case studies to be provided for hands-on)
  • Understanding high level process mapping and the application of root cause analysis
  • Introduction to process/problem-solving tools (fishbone/is-is not/5 Whys)
  • Develop corrective action that addresses the Root Cause


Target Audience
Basic to intermediate. 


Agenda
  • Process Improvement Fundamentals
  • Data Driven Decision Making
  • Data Driven Decision Making
  • Group practice and report out (data to trend)
  • Root Cause Analysis
  • Group practice and report out – scenario
  • Additional Information – Q&A


8 — Pharmacovigilance for QA (1/2 Day)

Wednesday, 28 September 2016, 1:00 - 5:00 PM

RQAP re-registration units: 1.00 non-GCP/non-GLP

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

Prices

  • Before 29 August 2016: Member Rate $285, Non-member Rate $385
  • After 29 August 2016: Member Rate $345, Non-member Rate $445

Description
This is a basic overview course, intended for individuals who have limited experience in pharmacovigilance/drug safety monitoring.

Objectives
At the end of the course, the participants shall be able to: 
  • Identify the history, the principles and regulatory framework for clinical safety/pharmacovigilance
  • Discuss the basic definitions of terms used in day-to-day work
  • Recognise EU, US and international safety surveillance regulatory requirements
  • Describe the criteria and elements of expedited and periodic reporting


Target Audience
GXP QA with beginner experience in Pharmacovigilance. 


Agenda
  • Legal basis for safety reporting including a historical perspective
  • Basic definitions and tools
  • Data collection and processing in post marketing phase
  • Medical evaluation
  • Safety reporting requirements in the post marketing phase
  • Introduction to risk management, epidemiological methods for signal detection and risk assessment


9 — GCP Beyond the Basics: Quality Management in the Clinical Study Environment (1 Day)

Thursday, 29 September 2016, 8:00 AM - 5:00 PM

RQAP re-registration units: 2.00 GCP/non-GLP

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

Prices

  • Before 29 August 2016: Member Rate $510, Non-member Rate $660
  • After 29 August 2016: Member Rate $570, Non-member Rate $720

Description
Emphasis from regulatory authorities within clinical study conduct is to design, develop and execute clinical studies using a Quality System Approach. While both the FDA and EU emphasize this approach, regulatory agencies provide little direction on how this can be achieved. The latest example of such an approach can be found within the FDA’s guidance on conducting a risk-based approach to monitoring. Risk management is an integral component of a quality system approach. As with a Quality System Approach many researchers do not have the knowledge or experience to conduct clinical trial risk management. This workshop will apply practical approaches and demonstrate associated tools and skills, to assist the participant in using a Quality System Approach within the clinical trial arena.

Objectives
At the end of the course, the participants shall be able to: 
  • Describe a quality system approach as it pertains to clinical trial conduct
  • Apply the concepts of a risk management approach and how it relates to a quality system approach
  • Define and demonstrate the a quality system approach tools to study conduct


Target Audience
GCO Auditors and managers of auditors at the site, CRO and Independent Consultant levels with some experience as GCP auditors. 


Agenda
  • Introductions
  • Review Course Objectives
  • Rationale for QS Approach to Clinical Trial Conduct
  • History of Quality Management Systems
  • QS Definition
  • Management Responsibilities
  • Components of a Clinical QS
  • QC/QA – Difference and Similarities
  • Quality by Design and Trial Development
  • Resources
  • Q&A
  • Risk Management
  • Risk Management Group Exercise
  • SOPs
  • Examples of SOPs in a QMS
  • Change Control
  • Contingency Plans
  • CAPA – Development and Execution
  • Root Cause Analysis
  • Non-conformance
  • Planned Deviations
  • Monitoring QMS via Internal Audit Program
  • Vendor Management
  • Root Cause Analysis Group Exercise
  • Q&A


10 — Data Quality/Data Integrity (1 Day)

Thursday, 29 September 2016, 8:00 AM - 5:00 PM

RQAP re-registration units: 2.00 GCP/GLP

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

Prices

  • Before 29 August 2016: Member Rate $510, Non-member Rate $660
  • After 29 August 2016: Member Rate $570, Non-member Rate $720

Description
Data Quality and Data Integrity are key components in measuring the reliability, accuracy and confidence in data. This course will provide the foundation attendees can use to define and apply Data Quality and Data Integrity concepts. Evaluation tools and techniques will be presented along with practical examples. A discussion on the associated industry guidance and the impact of poor Data Quality and Data Integrity will highlight the expectations for implementing these concepts and the consequences of not meeting those expectations.

Objectives
At the end of the course, the participants shall be able to: 
  • Define the terms Data Quality/Data Integrity
  • Identify what can impact Data Quality/Data Integrity
  • Describe methods and tools for evaluating Data Quality/Data Integrity
  • Describe the industry expectations for Data Quality/Data Integrity
  • Discuss the consequences of poor Data Quality/Data Integrity


Target Audience
Research and GXP professionals with an interest in broadening their perspective on Data Quality/Data Integrity concepts. 


Agenda
  • Data Quality/Data Integrity Lexicon Concepts to Consider:
    • Stakeholders
    • Importance of Quality of Source Data
    • Federal guidance
    • Defining the audit trail and data governance in maintaining data integrity
    • Hard Copy vs. Electronic Data
    • Using Trends and Tools for assessing data quality and integrity
    • Impact of using Cloud Computing Infrastructure
    • COTS/Internally Developed Software
    • Open Source Tools/Data
    • Electronic data issues
  • How to assess Data Quality/Data Integrity during an audit Cost of Poor Data
  • Quality/Data Integrity


11 — CAPA Day Two: CAPA Creation and Effectiveness - Beyond Training (across GxPs) (1 Day - this is day two of a two day course.)

Thursday, 29 September 2016, 8:00 AM - 5:00 PM

RQAP re-registration units: 2.00 GCP/GLP

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

Prices

  • Before 29 August 2016: Member Rate $510, Non-member Rate $660
  • After 29 August 2016: Member Rate $570, Non-member Rate $720

Description
An effective CAPA process begins with Root Cause Analysis and ends with CAPA Effectiveness. The process requires strategic direction, risk assessment, effective communication, accountability and responsibility agreed and clearly defined. This course will take a deep dive into the CAPA Process; the purpose, effective CAPA creation and how to use the information for fundamental organization change.
Objectives
At the end of the course, the participants shall be able to: 
  • Understand the value of an organization CAPA Process
  • Move from Root Cause identified to corrective and preventative action by:
  • Developing a CAPA that addresses the Root Cause (case studies to be provided for hands-on)
  • Ensure CAPA is valid and validated
  • Effectiveness checking of CAPA via internal audit review
  • Systematically implement global CAPA process


Target Audience
Intermediate to advanced. Must have completed the CAPA Problem Definition – Beyond Human Error class or have a solid understanding of Root Cause Analysis. 


Agenda
  • Review of Problem Definition and Root Cause Analysis
  • Group Refresher Root Cause Analysis
  • The Purpose of a CAPA
  • How to Facilitate CAPA Effectiveness
  • Group Practice (CAPA Steps 5-6)
  • Group Practice and Report
  • Fundamental Change through Trend Analysis and Process Improvement
  • CAPA Systems
  • Group Scenario – CAPA Systems and Communication
  • Q&A