September 2017 Quality College Course Descriptions




1 — Basic Good Laboratory Practice (2 Days)

Wednesday, 27 September 2017, 8:00 AM - Thursday, 28 September 2017, 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 28 August 2017: Member Rate $745, Non-member Rate $895, Student Rate $375
  • After 28 August 2017: 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 — Good Clinical Practice: The Basics (1 Day)

Wednesday, 27 September 2017, 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 28 August 2017: Member Rate $410, Non-member Rate $560, Student Rate $205
  • After 28 August 2017: 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 — Managing Change When Transitioning Research Organizations at Various Quality Levels into GxP Compliant Platforms (1 Day)

Wednesday, 27 September 2017, 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 28 August 2017: Member Rate $510, Non-member Rate $660, Student Rate $255
  • After 28 August 2017: Member Rate $570, Non-member Rate $720, Student Rate $285


Description
Transitioning from "unguided research" to GxP compliant processes requires a profound mind-set shift for staff. At the center of any change process is always people. The anticipated speed-to-value gained when introducing GxP compliant processes is often realized later than expected or only after much difficulty, for a variety of reasons which could be avoided. However, if accountabilities are clear, processes are controlled and transparent, and data management is secure, this transition can be smooth and quickly successful.

The workshop introduces all the elements critical for an effective (speedy) roll-out and lasting success of a GxP Compliant Platform. Attendees will learn how to avoid unnecessary stress and slow down. Focus will be on GLP as an example, but these concepts are applicable for transitioning or improving any GxP environment. When undergoing a change, staff at all levels can be leaders. Understanding these fundamentals applies to change leaders at any level.

• How to lead staff through change, generate participation and energy;
• Give examples of proven business and management tools and processes which catalyze the organizational adaptation with transparency, assure staff buy-in and help to accept new accountabilities;
• Introduces the do's and don’ts of a smooth roll-out of a QA platform and of organizational changes;
• Introduce key elements of a quality monitoring matrix as well as continuous improvement;
• Introduces innovative elements and processes for QA and GxP compliant organizations in response to new technology approaches and data "revolutions."

The training has been developed and applied in a variety of "real world" settings. The training will be interactive and combines learning sessions with hands-on teamwork.

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

• Understand and work with the dynamics of organizational and personal change and how to apply leadership and to create staff energy and buy-in.
• Apply proven tools, processes and measures to define all elements of a new GxP organization including pre-GxP Research and interaction with clients, customers and authorities with full team participation.
• Anchor the new organization during roll-out and continuous improvement.
• Assess and build the basis for innovative operation under in an established or newly formed GxP organization.

Target Audience
This training is ideal for:
QA professionals with 2 or more years of experience, testing facility management, research managers, and scientists in academia or in industry who are interested in implementing a GxP program. Research professionals interested in conducting regulatory research.


Agenda
Change Accomplished Through People
• Introducing Theory U* as guiding principle for organizational and personal change: goals, steps, staff and organizational energy, transparency, buy-in
• Quality Management change team accountability
• Change facilitation, success factors and "cardinal sins"

Process - Mapping: Quality, Efficiency and Speed
• Introducing "participatory mapping": tools and "hands-on" implementation
• 30,000 vs 1,000 ft view
• Avoiding gaps, completeness check
• Evaluating and optimizing maps for goals of change

RACI: Art of Transparency, Accountability, Buy-in
• Based on process and organizational maps introducing RACI
• Establishing deliverables, transparency, functional accountabilities, hand-shakes, timelines and quality criteria
• Deriving personal goals and buy-in
• Success factors and "cardinal sins"

Creating SOP: The Guiding Principles
• Derived from mapping and RACI: SOP as guiding principles for the new organization
• Structure, content and requirements of SOP
• Management and accountabilities

Planning, Managing Data & Information: Innovation from Research
• Data architecture or databases
• Information quality management: what to learn from finance controlling
• Value of planning models: current agile planning and/or learning from the past
• Metadata analysis: role in Quality Management

Long-term Success and Continuous Improvement
• Implementation in "Theory U"
• Monitoring achieved goals and quality
• Fixing the "bugs"
• Listen to quiet voices
• Create a climate of innovation


 

4— Good Clinical Practice: Beyond the Basics (1 Day)

Thursday, 28 September 2017, 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 28 August 2017: Member Rate $510, Non-member Rate $660, Student Rate $255
  • After 28 August 2017: Member Rate $570, Non-member Rate $720, Student Rate $285

Description
The course will combine lecture with participant group exercises to allow participants to perform activities related to QSM. Proposed activities will include identifying risks for a provided clinical study scenario, categorizing the risks and developing a corrective and preventative action plan (CAPA) to address a specific risk scenario.

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 risk management and understand how it relates to a quality system approach
  • Explain and utilize 2 tools for a quality system approach to study conduct


Target Audience
GCP and other type auditors seeking additional advanced GCP auditing content.


Agenda
  • 08:00 – 08:30 Introductions Review Course Objectives
  • 08:30 – 10:00 Presentation on QSM
  • 10:00 –10:15 Morning Break
  • 10:15 – 11:00 Presentation on Risk Management
  • 11:00 – 12:00 Group Exercise on Risk Management
  • 12:00 – 13:00 Lunch
  • 13:00 – 13:30 Vendor Management 
  • 13:30 – 15:15 Presentation on Root Cause Analysis and CAPA
  • 15:15 – 15:30 Afternoon Break 
  • 15:30 – 17:00 CAPA Group Exercise


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

Thursday, 28 September 2017, 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 28 August 2017: Member Rate $510, Non-member Rate $660, Student Rate $255
  • After 28 August 2017: 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 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
  • 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


6— History Behind the FDA GLPs and Their Application (1/2 Day)

Friday, 29 September 2017, 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.

Prices

  • Before 28 August 2017: Member Rate $285, Non-member Rate $385, Student Rate $145
  • After 28 August 2017: 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 BioTest 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


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

Friday, 29 September 2017, 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 28 August 2017: Member Rate $285, Non-member Rate $385, Student Rate $145
  • After 28 August 2017: 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.
• 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 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
  • Provide Lessons Learned