September 2019 Quality College Course Descriptions




1 — GLP 101: Basic Training (2 Day)

Monday, 23 September 2019, 8:00 AM - Tuesday, 24 September, 5:00 PM

RQAP re-registration units: 4 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 26 August 2019: Member Rate $745, Non-member Rate $895, Student Rate $375
  • After 26 August 2019: 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
  • Effectively communicate the requirements of FDA GLPs and identify where topical differences exist between FDA and EPA GLP requirements
  • Interpret and apply GLP requirements using a variety of resources
  • Use the knowledge obtained 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 — GCP 102: Introduction to GCP (1 day)

Monday, 23 September 2019, 8:00 AM - 5:00 PM

RQAP re-registration units: 2 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 26 August 2019: Member Rate $410, Non-member Rate $560, Student Rate $205
  • After 26 August 2019: Member Rate $470, Non-member Rate $620, Student Rate $235

Description
This is a basic course providing an overview of the fundamentals of Good Clinical Practices.

Objectives
At the end of the course, the participants shall be able to: 
  • Define what constitutes Good Clinical Practices
  • Find key regulations within 21 CFR GCP Regulations and ICH E6(R2)
  • Describe 3-4 activities to be done during an investigator site audit


Target Audience
GMP/GLP Auditors with little GCP experience or new auditors with less than 12 months experience.


Agenda

8:00 – 8:30 Welcome  - Housekeeping, Agenda Review and Introductions
8:30 – 9:15 Principles of GCPs
9:15 – 10:00 GCP Regulations and Guidelines
10:00 – 10:15 Break
10:15 – 10:45 Electronic Records; Electronic Signatures
10:45 – 11:15 Protection of Human Subjects
11:15 – 11:40 Institutional Review Boards
11:40 – 12:00 Financial Disclosure
12:00 – 1:00 Lunch
1:00 – 1:40 Essential Documents – The Trial Master File
1:40 – 2:20 Investigational Product Accountability
2:20 – 3:00 Safety Reporting
3:00 – 3:15 Break
3:15 – 3:45 Investigator Site Audits
3:45 – 4:15 Service Provider Audits
4:15 – 4:45 Regulatory  Inspections
4:45 – 5:00 Q&A Wrap Up

 



3 — CAPA 101: Problem Definition – Beyond Human Error (1 Day)

Monday, 23 September 2019, 8:00 AM - 5:00 PM

RQAP re-registration units: 2 GCP, GLP

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

Prices

  • Before 26 August 2019: Member Rate $510, Non-member Rate $660, Student Rate $255
  • After 26 August 2019: Member Rate $570, Non-member Rate $720, Student Rate $285


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 difference between reactive and proactive
  • Know what is CAPA?
  • Define a problem (case studies to be provided for hands-on)
  • Understanding high level process mapping
  • Apply root cause analysis, including process tools (fishbone/is-is not/5 Whys)
  • Develop corrective action that addresses the Root Cause


Target Audience
This training is ideal for:
Basic


Agenda
  • Define the problem - What, How Much, Where & When
  • Review Data to detect a "signal"
  • Apply Root Cause Analysis
  • Develop corrective action


4 — CSV 201: Auditing Software and Data Providers with a focus on Cloud Services (1 day)

Monday, 23 September 2019, 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 26 August 2019: Member Rate $510, Non-member Rate $660, Student Rate $255
  • After 26 August 2019: 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
  • 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 Procedure
  • Audit Report & Follow-up



    5 — GCP 201: Hot Topics and Industry Trends (1 Day)

    Tuesday, 24 September 2019, 8:00 AM - 5:00 PM 

    RQAP re-registration units: 2 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 26 August 2019: Member Rate $510, Non-member Rate $660, Student Rate $255
    • After 26 August 2019: Member Rate $570, Non-member Rate $720, Student Rate $285

    Description
    This highly interactive course with 2 FDA speakers will offer insight into FDA vs OHRP oversight of clinical studies, how to prepare for and conduct a clinical study report (CSR)
    audit, recent REMS program changes, how block chain and arti􀂦cial intelligence are beginning to be used in clinical research and more. FDA BiMo director will present a case
    study of interest to support group discussion. Come prepared to engage with other professionals in lively discussion and break out activities.

    Objectives
    At the end of the course, the participants shall be able to: 
    • Implement 2 best practices for planning and conducting a clinical study report (CSR) audit
    • Describe at least 2 recent changes to the FDA REMS program which may impact auditing
    • Identify how block chain and arti􀂦cial intelligence (AI) may impact the clinical trial landscape , i.e., identify at least two "use cases" for block chain and AI
    • Discuss how OHRP and FDA oversight of clinical studies is similar and how that is different.
    • Describe GCLP expectations based upon the EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples.


    Agenda
    8:00–8:30: Welcome, introductions, housekeeping
    8:30 –10:00: Auditing a Clinical Study Report with activity/exercise
    10:00 – 10:15 BREAK
    10:15-11:15: Insights into FDA vs OHRP Oversight of Clinical Research
    11:15-12:00PM: Blockchain Basics and Use Cases
    12:00 – 1:00: LUNCH
    1:00-2:30: TBD Case Study
    2:30-3:00: FDA REMS Program Update and Auditing Tips
    3:00-3:15 BREAK
    3:15-4:30 GCLP based on the EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples
    4:30–5:00: Presenter Panel/Audience Q&A,wrap up

     



    6 — CAPA 201: CAPA Creation and Effectiveness - Across GxPs

    Tuesday, 24 September 2019, 8:00 AM - 5:00 PM

    RQAP re-registration units: 2 GCP, GLP
    *Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

    Prices

    • Before 26 August 2019: Member Rate $510, Non-member Rate $660, Student Rate $255
    • After 26 August 2019: Member Rate $570, Non-member Rate $720, Student Rate $285

    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
    8:00 AM - 10:00 AM
    • Review of Problem Definition and Root Cause Analysis
    • Group Refresher Root Cause Analysis

    10:00 AM - 10:15 AM
    • Break

    10:15 AM - 12:00 PM
    • The Purpose of a CAPA
    • How to Facilitate CAPA Effectiveness
    • Group Practice (CAPA Steps 5-6)

    12:00 PM - 1:00 PM
    • Lunch Break

    1:00 PM - 3:00
    • Group Practice and Report
    • Fundamental Change through Trend Analysis and Process Improvement

    3:00 PM - 3:15 PM/span>
    • Break

    3:15 PM - 5:00 PM
    • CAPA Systems
    • Group Scenario • CAPA Systems and Communication
    • Q&A

     

     



    7 — General 204: Right-Sizing the QMS for the Start-Up/Virtual Company: What Do You Need and When?

    Tuesday, 24 September 2019, 8:00 AM - 5:00 PM

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

    Prices

    • Before 29 March 2019: Member Rate $510, Non-member Rate $660, Student Rate $255
    • After 29 March 2019: Member Rate $570, Non-member Rate $720, Student Rate $285

    Description

    In today’s drug development landscape, many pharmaceutical companies start off as virtual operations to keep costs as low as possible. Virtual companies are typically run by one or two founders with a small internal team and a group of consultants. With the rise of contract research organizations (CROs), contract manufacturing organizations (CMOs) and laboratories, most everything in the drug development process can be performed by outsourcing. Virtual companies are becoming more common and seen as attractive by investors and larger pharmaceutical companies.

    All companies in the biopharma and pharma space must comply with regulatory demands and often many virtual companies feel they do not require a quality system as much of the regulated work is outsourced to vendor companies. While vendors may have a QMS in place, both the FDA and the European Health Authorities have been clear that they expect the Sponsor (virtual company) to take responsibility for the oversight of all contracted vendors. A virtual company of a few people will need to have at a minimum a quality system that documents the vendor oversight process. Meeting this expectation requires a riskbased approach.

    Objectives
    At the end of the course, the participants shall be able to: 
    • Determine what processes and procedures a virtual company may need to be successful and when to implement such procedures;
    • Ensure quality is involved in the cross-functional team;
    • Conduct risk assessments, analyzing the appropriate vendor controls, based on the services or products provided by that supplier;
    • Monitor and document vendor performance so that is not overly burdensome; and
    • Ensure appropriate written quality agreements are completed between all parties regarding responsibilities for GXP activities.


    Target Audience

    GxP Quality Professionals who are currently working for small start-up or virtual pharmaceutical/biotech companies as the only QA professional with at least 5 years experience in QA and/or QA professionals that are looking to grow in their experience of GMP, GLP and GCP quality management in the small company environment.

    Agenda

    2 hours - Starting point for a GXP QMS
    1 hour - Backbone for Vendor Management (more than just
    audits)
    1 hour - QA’s role in Vendor Management Lifecycle
    2 hours - Harmonization of GxPs and where you need
    separation
    1 hour - QA vs. QC
    We are planning multiple audience engagement break out
    sessions throughout the day.



    8 — GLP 102: Lies, Deceit, and Drift: The Creation of the FDA GLPs and Why They Are Still Relevant Today

    FULL TITLE: GLP 102: Lies, Deceit, and Drift: The Creation of the FDA GLPs and Why They Are Still Relevant Today
    Thursday, 2 May 2019, 1:30 PM - 5:30 PM

    Wednesday, 25 September 2019, 8:00 AM - 12:00 PM

    RQAP re-registration units: 1 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 26 August 2019: Member Rate $285, Non-member Rate $385, Student Rate $145
    • After 26 August 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
  •  



    9 — GCP 301: Advanced Training

    Wednesday, 25 September 2019, 8:00 AM - 5:00 PM

    RQAP re-registration units: 2 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 26 August 2019: Member Rate $510, Non-member Rate $660, Student Rate $255
    • After 26 August 2019: 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 minimum 5 years GCP experience. If beginners wish to attend its HIGHLY recommended they attend the Basic GCP Course prior

    Agenda

    • 8:00 - 8:30 Welcome, Housekeeping, Agenda Review and Introductions
    • 8:30-9:15 Components of a Quality Management System (QMS)
    • 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
    • 11:00 - 12:00 Practical Application of a Quality Management System (QMS) Approach within the GCP Arena
    • 12:00 - 1:00 Lunch
    • Lunch Break
    • 1:00 - 2:00 GCP Risk Management
    • 2:00 - 3:00 Root Cause Analysis and CAPA Under GCPs
    • 3:00 - 3:15 Break
    • 3:15-4:30 Additional Strategies for Planning, Conducting and
      Reporting Audits Under a QMS Approach
    • 4:30 - 5:00 Q&A

    10 — GMP 201: Trail-blazing GMPs from Auditing to Zero 483 Observations

    Wednesday, 25 September 2019, 8:00 AM - 5:00 PM

    RQAP re-registration units: TBD

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

    Prices

    • Before 26 August 2019: Member Rate $510, Non-member Rate $660, Student Rate $255
    • After 26 August 2019: Member Rate $570, Non-member Rate $720, Student Rate $285

    Description

    The course provides an overview of GMP Quality Systems, Manufacturing Operations, Laboratory Operations, Facilities and Equipment. Emphasis will be provided to GMP Data Integrity, Auditing for GMP Compliance and understanding GMP Validation of Methods, Processes, Equipment /Instrumentation and Systems.

    Objectives
    At the conclusion of the course, attendees will understand what to look for when outsourcing, auditing or reviewing GMP operations and facilities. Participants will gain critical perspective on running a risk based GMP Quality Audit Program. They will be aware of the latest GMP Hot Topics including Data Integrity, Cold Chain, GMP Software as a Service, Serialization, and Method Validation. Most importantly, participants will know where to access knowledge bases on various GMP topics.

    Target Audience
    Quality Assurance staff who may audit or review GMP operations Industry Professionals who want GMP understanding

    Appropriate for individuals with 2+ years in industry

    Agenda
    Introducing cGMPs
    History behind GMPs: From Snake Oil to CRISPR
    GMP Regulations: U.S., E.U., Canada and Rest of World:  Similarities and Differences
    Enforcement in the GMPs:  Presumed Guilty and need to prove Innocence

    GMP Operations 
    GMP Quality Systems:  How unique are they really?  Really!??
    Material and Manufacturing Systems:  From biomaterials to placebos to CAR-T
    Clinical versus Commercial GMPs:  from Randomization codes to Recalls
    GMP Laboratories:  Analytical Development and Quality Control:  What is this stuff?
    Stability Testing Laboratories:  Can I take this expired ibuprofen? 
    Microbiology Laboratories and Sterility Testing:  You’ll never buy another fish tank!
    Outsourcing GMP Operations:  You cannot outsource oversight!
    GMP Quality Agreements:  Where the rubber hits the road…
    The link between GMPs and Pharmacovigilance:  Commercial Operations too!!

    Auditing GMPs
    Types of GMP audits: From Abattoir to Printers to Oracle
    General audit technique: e.g. What carries over from GCPs / GLPs?
    Assessing Compliance, Business and Regulatory Risk: e.g.  What really matters!
    Hot Topics: like Cold Chain, Serialization and Data Integrity
    GMP MythBusters:  How many people have been debarred for lack of GMP compliance?  

    Validation 
    Equipment Qualification:  Does the cyrostorage tank it really work?
    Metrology:  Is it really -196 oCentigrade?
    Facilities and Utilities:  How do we fill the cryostorage tank?
    Process Validation:  Will our frozen cells be viable?
    Cleaning Validation:  Or just buy disposables?
    Method Validation:  ICH Q2 Tripartite Guidance
    Compendial Methods:  USP & PharmEur
    Software Validation: Paradigm shift both in technology and enforcement

    Data Integrity
    Understanding Data Integrity:  Think about your computer in a whole new way!
    ALCOA isn’t just making Aluminum!
    Identify Risk Areas:  ICH Q9 Tripartite Guidance
    Data Lifecycle:  From cradle to grave… and then some.

    GMP Inspections 
    What to expect?  The unexpected!
    What are the boundaries?  There are no boundaries….
    Proper Preparation and Execution:  Boy Scout Motto
    The random factors:  e.g. The investigator getting rear ended the weekend prior.
    Writing a 483 Response:  e.g. Don’t tell the FDA to pound sand!!



    11 — General 203: Business Continuity and Disaster Recovery
    Wednesday, 25 September 2019, 1:0PM - 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 26 August 2019: Member Rate $285, Non-member Rate $385, Student Rate $145
    • After 26 August 2019: 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

    • 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.

     

    Agenda

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