1 — GCP 202: Hot Topics & Industry Trends (2 days)

10:00 AM EDT, Monday, 19 April 2021 - 2:30 PM EDT, Tuesday 20 April 2021

RQAP re-registration units: 8 GCP, non-GLP

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

Registration Fees
SQA Member: $445     Student: $225     Non-member: $565

Description
This interactive workshop with FDA and expert industry speakers will focus on emerging technologies, the evolution of clinical trial design, trial subject compensation versus reimbursement, remote source document verification and what happens to EUAs once the emergency is over.

Objectives
At the end of this course participants will be able to:

• Discuss the potential for introduction of bias through reimbursement to trial subjects (versus subject stipends)
• Describe the process for EUAs after the Public Health Emergency is over
• Explain Basket Trials, Umbrella Trials and Master Protocols
• Identify 2 areas where new technology (AI/Block Chain or Machine Learning) are being used in clinical trials

Target Audience
The topics are GCP in nature and they are advanced materials. GCP QA professionals with 3+ years of experience looking to broaden their knowledge of emerging technologies and trends which may impact Clinical QA.

Agenda
    Day 1

2 — GLP 104: Auditing Techniques (2 days)

10:00 AM EDT, Monday, 19 April 2021 - 2:30 PM EDT, Tuesday 20 April 2021

RQAP re-registration units: 8 GLP, non-GCP
 
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Registration Fees
SQA Member: $445     Student: $225     Non-member: $565

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

Objectives
At the end of this course participants will be able to:

• Understand the regulatory requirements for FDA GLP QA, including high-level EPA/OCED GLP differences
• 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 protocols, 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 an FDA Good Laboratory Practice facility.
 
Agenda

1. Course Overview
2. Quality Assurance Responsibilities
3. CPGM Overview
4. Protocol Audits
5. Process and Phase Inspections

3 — GMP 101: GMP Foundations (2 days)

10:00 AM EDT, Monday, 19 April 2021 - 2:30 PM EDT, Tuesday 20 April 2021

RQAP re-registration units: 8 non-GCP, non-GLP

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

Registration Fees
SQA Member: $445     Student: $225     Non-member: $565

Description
This course provides an introductory overview of the History of the GMP Regulations, Quality Management Systems, Plant Operations, Laboratory Operations, Quality Engineering, Regulatory Compliance and select GMP Specialty Topics.

Objectives
At the end of this course participants will be able to understand the purpose of the GMP regulations, how the regulations developed over time, provide a foundation of the regulations.

 Target Audience
Quality Assurance professionals with 0-2 years of GMP QA experience.

Agenda

• Course Agenda
• Good Manufacturing Practices
• History of the US Food and Drug Administration
• Quality Management Systems
• Good Documentation Practices
• Electronic Records
• Change Control
• Deviation/Non-Conformance
• Plant Operations
• Laboratory Operations
• Regulatory Compliance
Specialty Topics Medical Device
• Phase Appropriate GMPs

 

4 — GCP 301: Advanced Training (2 days)

10:00 AM EDT, Wednesday, 21 April 2021 - 2:30 PM EDT, Thursday, 22 April 2021

RQAP re-registration units: 8 GCP, non-GLP

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

Registration Fees
SQA Member: $445     Student: $225     Non-member: $565

Description

This interactive course 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 course 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 this course participants will 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 2 years GCP experience. If beginners wish to attend its HIGHLY recommended they attend the Basic GCP Course prior.

Agenda

• GCP Quality Management Systems From Regulator Perspective
• GCP Quality Management System (QMS) From Sponsor Perspective
• Collecting and Assessing Study-specific and QA Metrics
• Remote Auditing
• Pending ICH E6(R3)

 

5 — GEN 205: QA and Supply Chain

Wednesday, 21 April 2021, 10:00 AM - 2:30 PM

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

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

Registration Fees
SQA Member: $275     Student: $135     Non-member: $355

Description
QA and Supply Chain together touch on many topics ranging from data integrity/data quality, to Vendor/Supplier Qualification and Management, to Quality Management to GMP compliance. Established ways of doing have to be questioned in order to increase the reliability of the information, hence improve the risk assessment, hence turn the organization into a proactive mode. To do so, we apply some of the frameworks utilized for business model innovation to this specific relationship.

Objectives
At the end of this course participants will be able to:

• Recognize similarities of the business model concept and the internal organization
• Use de 6 pathways to explore significant improvements in Supply-Chain related processes
• Develop a new model
• Examine the benefits thereof
• Reproduce this method within any given organization
  
  

Target Audience
Head of QA who envisage to improve existing processes related to the supply chain, knowing GMP constraints. Supplier QA Managers with minimum 5 years' experience who are well aware of the processes throughout the chain.

Agenda

Part 1 (60 min): The similarities between a business model and internal organization
40 min - Theory
This part describes what a Business model is, and which are its relations to the external and internal world. It also provides a tool to visualize attributes of differentiation and a diagnostic framework.
20 min - Practice: draw chart of your own "internal business model", define the main attributes of the "internal offer" and apply the diagnosis tool to your current organization.

Break – 15 min

Part 2 (2h15-2h30) - The exploration begins
45-60 min Theory
This part presents the 6 pathways to use to solve an identified problem and provides a guide to build up the premises of a new model.

Break – 15 min

90 min -Practice: It is your turn to explore specific Use cases in small groups:

• Supplier approval
• Ongoing Supplier Assessment
• MA-Transfer
• Deliverable: prepare a presentation of the new model to all attendees

Part 3 (30 min)
 3 groups, drawn, will briefly present their deliverables to all attendees (10 min. max. per group)
 

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

Wednesday, 21 April 2021, 10:00 AM - 2:30 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.

Registration Fees
SQA Member: $275     Student: $135     Non-member: $355


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 class presents GLP training in a novel way, by linking fraud to regulations to SOPs to the FDA Compliance Program to recent 483s.

Objectives
At the end of this course participants will be able to:

1. Understand the history behind the FDA GLP regulations
2. Compare the deceptions and fraud to the regulations and Compliance Program
3. Use relevant course material to situations at their firms or remote audits
4. Apply history learnings to write more clear audit 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 hearings, Bressler Report
• Regulatory action, IBT Trial
• Practical exercises to write robust audit

 

7 — GEN 107: New Skills for Quality Assurance Professionals

10:00 AM EDT, Thursday, 22 April 2021 - 2:30 PM EDT, Friday, 23 April 2021

RQAP re-registration units: 8 non-GCP, non-GLP

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

Registration Fees
SQA Member: $445     Student: $225     Non-member: $565

Description
The current era presents huge opportunities for the quality professional to add value, develop personally and professionally, and help their organizations embrace new technology, innovating to move beyond stagnant practices. This course aims to give attendees new perspectives on what's important and where leverage can be applied to create such opportunities, solve problems, improve culture and reduce busyness. It will span a variety of topics encompassing both human- and technology-centered material, with an extensive hyperlinked "map" of references provided to allow further research and learning.

Objectives
At the end of this course participants will be able to:

• Have a better understanding of current industry transformations (including Industry 4.0, Quality 4.0) and their implications for quality professionals; know what skills are valuable now and in the coming years, and be able to place these skills in the context of the QA role
• Acquire new skills and techniques for influencing culture to improve quality and productivity
• Have a basic understanding of a variety of tools from areas such as systems thinking, analytical design and learning sciences, as well as useful apps and sources of further
• Understand the Intelligent Automation spectrum and the threats and opportunities this presents for quality professional.

Target Audience
Forward-looking QA professionals who are interested in the effects of current and future trends on the quality assurance role and the skills that will be needed to continue to add value as QA over the coming decades.

Agenda

Part 1: Why, What and How?

• Why reskill?
• Further into the Future: Quality 4.0
• What skills are needed? (information from WEF, Udemy, Deloitte and other sources)
• Lessons from VUCA: Risk, Uncertainty, Puzzles and Mysteries
• What and How? The Waterwheel (adapted from Jim Collins)

Part 2: What’s in the Water? Systems and Culture

• Beating busyness and influencing culture
• Systems thinking)

Part 3: Spinning the Wheel

• Analytical design – from Data to Insights
• Data and the Data Factory
• Learning sciences
• Getting to outcomes: Design Thinking, Emotional Intelligence, coaching)

 

8 —GMP 201: Effective GMPs (2 days)

10:00 AM EDT, Thursday, 22 April 2021 - 2:30 PM EDT, Friday, 23 April 2021
 
RQAP re-registration units: 8 non-GCP, non-GLP

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

Registration Fees
SQA Member: $445     Student: $225     Non-member: $565

Description
The course provides a foundational understanding of GMP Quality Systems, Manufacturing Operations, Laboratory Operations, Facilities, Equipment, and Systems. Both near-term and longer-term critical topics will be covered including FDA Emergency Use Authorization, Drug Supply Chain Security, Data Integrity, Cold Chain, Supplier Compliance, and Method Validation.

Objectives
At the conclusion of the course, attendees will understand the foundations of GMP Quality and Compliance. They will know what to establish for in-house operations, what to look for when outsourcing, how to maintain compliance, and how to host an inspection. Participants will gain perspective on risk-based approaches to GMPs. Most importantly, participants will learn where to access knowledge based 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 the industry

Agenda
Topics covered include:

• Rationale behind GMPs
• Quality Systems: Complaints, QRM CAPA, Out of Specifications/Trend, Supplier Qualification, AQR
• Manufacturing Technologies: Biologics Upstream, Downstream and Aseptic Fill, Aseptic Monitoring
• Laboratory Techniques: HPLC, GC, MSD, UPLC, micro, stability
• Quality Engineering: Facilities Utilities Equipment Qualification, Preventive Maintenance and Metrology
• Supplier Oversight
• Part 11 - Electronic Records / Electronic Signatures
• Computer Software Validation
• Data Integrity
• Laboratory Instrumentation and Manufacturing Equipment Validation
• Compendia Method Verification
• Inspection Prep / Management
• Hosting U.S Inspections
• Responding to Observations
• Specialty Topic: Combination Products

 

 

10 — GLP 105: Intro to FDA GLP BIMO Compliance

Friday, 23 April 2021, 10:00 AM - 2:30 PM EDT

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.

Registration Fees
SQA Member: $275     Student: $135     Non-member: $355
 
Description
This class will review the FDA Compliance Program for Bioresearch Monitoring of the Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) regulations (7348.808). FDA implemented this program of regular inspections and data audits to monitor laboratory compliance with the GLP regulations. The Compliance Program directs the FDA Investigators how to conduct their GLP inspections of firms.

Objectives
At the end of this course participants will be able to:

1. Understand how the FDA uses the Compliance Program to perform inspections
2. Apply the GLP Compliance Program information to build compliant processes
3. Understand what records to provide the FDA Investigator/s during an inspection
4. Interpret selected warning letter findings based on understanding the Compliance Program and GLP regulations

Target Audience
FDA GLP Auditors and QA Mangers, from beginners to experienced, as well as Study Directors and Testing Facility Management

 Agenda

• Welcome, Schedule, Introductions
• What is the FDA GLP Compliance Program (CP)?
• How can industry use the GLP CP?
• Objectives of the CP
• Types of Inspections, Study Selection, Inspection Team
• How are inspections scheduled, What documents are reviewed?
• Sections of regulations, warning letter lessons, and real-life examples
• Data Audits, Establishment Inspection Report (EIR)
• FDA inspection management, sample collection and analysis, Headquarters responsibilities
• Changes between the versions issued 21Feb2001 and 01May2018
• Question and Answers
    

11 — GEN 108: QA Roles in the Drug Development Process (2 days)

10:00 AM EDT, Monday, 26 April 2021 - 2:30 PM EDT, Tuesday, 27 April 2021 
 
RQAP re-registration units: 8 GCP, GLP

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

Registration Fees
SQA Member: $445     Student: $225     Non-member: $565

Description
This course will walk you through the drug development process from the basic research and through the various stages. Introduce the role of QA from the start of the process through the stages. Bring in real world experience to demonstrate how to use this information to better the overall process.

Objectives
At the end of this course participants will be able to:

1. To identify the types of risks inherent at stages of the drug development process.
2. Be able to identify how the risks may impact downstream activities and
3. Enable the QA representative to ask more strategic and probing questions and get more informative answers.
4. Help team members understand the types of risks and questions they should be mindful of

Target Audience

Quality Professionals that have little and/or limited experience in all areas of the drug development process specifically GCP and GLP

Agenda
Introduction into best practices in basic research; manufacturing what is important based on stage of the products development; what are the requirements as the product moves into testing under the GLPs; what are the GLP testing requirements for the material, what studies are required and when to support the development; interactive exercise related to the material provided in the first ½ of the training. Second ½ day to focus on movement into clinical testing, new requirements for the material under the GMPs and the GCP Phases of research. There will be in depth discussion on the phases and types of clinical trials; what is required to move to new phases of testing, including defining named patient protocols, and registries. Day 2 will close with an interactive exercise related to the material presented.
 

12 —CAPA 101: CAPA Creation and Effectiveness: Beyond Basics (2 days)

10:00 AM EDT, Monday, 26 April 2021 - 2:30 PM EDT, Tuesday, 27 April 2021 

RQAP re-registration units: 8 GCP, GLP

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

Registration Fees
SQA Member: $445     Student: $225     Non-member: $565

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 this course participants will be able to:

• Review of Problem Definition and Root Cause Analysis
• Understand the purpose of a CAPA
• Develop CAPA that addresses the Root Cause
• Ensure CAPA effectiveness
• CAPA Systems
• How to use this information for fundamental change
• Corporate CAPA
• Process Improvement

Target Audience
Quality individuals who are a part of the corrective/preventive action process for process improvement.


 

13 —GMP 302: Critical Controls for Aseptic Processing (2 days)

10:00 AM EDT, Monday, 26 April 2021 - 2:30 PM EDT, Tuesday, 27 April 2021 

RQAP re-registration units: 8 non-GCP, non-GLP

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

Registration Fees
SQA Member: $445     Student: $225     Non-member: $565

Description
A multitude of controls need to be considered for aseptic processing. While specific applications can be different (biologics, biomaterials, vaccines, CAR-T), the foundational requirements for producing a sterile product are shared. This course will not directly cover terminally sterilized aseptic production. The course will review several foundational factors from the perspective of plant, personnel, materials monitoring, equipment, utilities and cleaning..

Objectives
At the end of this course participants will be able to:

• Gain an understanding and be able to identify the critical controls for aseptic processes.
• Auditors will gain a clear understanding of relevant topics for review and how to confirm safety and compliance of aseptic products.

Target Audience

• GMP Aseptic Operations personnel with 5 or more years of aseptic experience
• QA Auditors with 10 or more years of general experience
• QA Generalists with 15 or more years' experience who desire an understanding of advanced aseptic topics and how they can affect clinical projects and commercial products

Agenda

• Introduction to the types of aseptic processing
• A review of plant design: personnel, material, and waste flows, clean room classifications, gowning and washroom requirements
• A review of personnel training and controls: hygiene, gowning, aseptic qualification, and personnel monitoring
• A review of product and environmental monitoring: sterility testing, endotoxin, bioburden limits, environmental recoveries, identification, local flora, growth promotion, viral and mycoplasma detection, particulate monitoring, viable monitoring, water monitoring, utilities monitoring, materials monitoring and aseptic challenges
• A review of clean utilities: HVAC design, flows, classification, differentials, visualization studies; WFI and other clean utility design and materials of construction
• Cleaning: autoclaving, depyrogenation, sterilization in place, and vapor hydrogen peroxide

 

14 — CSV 205: Over the River and Through Woods: Following the Audit Trail

Wednesday, 28 April 2021, 10:00 AM - 2:30 PM EDT

RQAP re-registration units: 4 GCP, GLP

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

Registration Fees
SQA Member: $275     Student: $135     Non-member: $355

Description
Electronic records in the GxP woods are "lovely, dark, and deep", but impossible to navigate if you don't have an audit trail. To assure data integrity, individuals involved in a process, as well as Quality Assurance Auditors, need to review audit trails. How are audit trails reviewed when filtering is difficult? Do study monitors routinely review audit trails? Does the QAU address their audit trail practices in an SOP (as per OECD guidance)? When is audit trail review useful or necessary? This training has been developed following a 2019 annual meeting 90-minute roundtable session. We will begin with an overview of the regulations covering audit trails and points made by regulators concerning audit trails and data integrity. This will be followed by more in-depth discussions covering many questions with which auditors struggle, including the difference between system logs and audit trails and how both are useful in study-based audits and data integrity audits. The CVIC Data Integrity and Governance group has compiled several audit trail examples to use during discussions of scenarios. The examples, both real and fictitious, come from a variety of systems used in GLP, GMP, and GCP regulated industries. Individuals attending the training will leave with a greater understanding of points to consider concerning audit trails and more confidence in how to find compliance and data integrity problems when viewing audit trails.

Objectives
At the end of this course participants will be able to:

• Describe requirements for electronic audit trails
• Explain how both system logs and audit trails can be used to assess data integrity
• Analyze a variety of compliant and non-compliant audit trails
• Summarize gaps in compliance for example data based on audit trail review and recommend corrective actions.

 Target Audience

• GLP, GCP, and GMP auditors responsible for reviewing and inspecting electronic instruments, equipment and system records and data.
• Anyone responsible for data integrity in electronic systems

Agenda

• 10 Introductions and Course Overview
• 40 plus 5 min Q&A Data Integrity and Regulatory Requirements Overview
• 30 plus 5 min Q&A Managing the Audit Trail Review Process and Paper Records Compared to their Electronic Audit Trail Equivalent
• (Topics covered include: who reviews them, where is this process defined, where do the audit trails go, how to manage extensive audit trails)
• 10 min BREAK
• 10 plus 5 min Q&A
• System Logs vs. Audit Trails
• 5 Group work – Review of example audit trails and discussion
• 30 min Group Work – Review of example audit trails and discussions (continued)
• 10 min BREAK
• 10 plus 5 min Q&A
• Audit Trails in Action (Topics include: audit trail use as a monitoring tool for data integrity and audit trails for analyzed data)
• 15 min Warning Letter review
• 10 min Individual Work – Mock inspection and report on examples provided using electronic audit trails
• 30 min Discuss specific issues and questions submitted at the time of registration/Open Discussion

 

16 — GEN 101: QA Consulting

Thursday, 29 April 2021, 10:00 AM - 2:30 PM EDT

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

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

Registration Fees
SQA Member: $275     Student: $135     Non-member: $355

Description
A consultant is an individual who possesses special knowledge or skills and provides that expertise to a client for a fee. This interactive course will give examples of expectations of the sponsor (your client) and also CROs that host audits in certain situations. It will also cover ways of organizing the consulting business with regard to legal organization, tax information, physical office choices, marketing, payment structure insurance and other important needs for a consultant. In addition, we will discuss hints and recommendations to bring more value to your clients and yourself as a consultant.

Objectives
At the end of this course participants will be able to:

• Develop ideas for setting up and running a consulting practice.
• Weigh the pros and cons of different types of legal and tax options.
• Learn sponsor's (your client) expectations, needs and methods of interactions.
• Understand what laboratories/CROs expect from you.

Target Audience
This course is targeted to those QA Professionals who want to learn more about consulting or have a desire to pursue consulting as a career.

Agenda

• Introduction
• Meeting expectations of your client (the Sponsor)
• What the CROs expect from you as a consultant
• Setting up and running your consulting company
• How to be a valuable QA Consultant

 

17 — GEN 104: The Three Cs of SOPs

Tuesday, 29 April 2021, 10:00 AM - 2:30 PM EDT

RQAP re-registration units: 4 GCP, GLP

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

Registration Fees
SQA Member: $275     Student: $135     Non-member: $355
 
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 this course participants will 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

• Section 1: Introduction
• Section 2: Understand the Purpose and Benefit of Effective SOPs
• Section 3: SOP on SOPs
• Section 4: Characteristics of Good SOPs
• Section 5: Art to Writing SOP Content
• Section 6: Relationship between Plan/Protocol, SOPs, and Data
• Section 7: Deviations
• Section 8: Awareness/Training
• Section 9: Why people don't use SOPs
• Section 10: Wrap up