1 — GLP 101: Basic Training (2 Day)

Monday, 30 March 2020, 8:30 AM - Tuesday, 31 March 2020, 5:30 PM

RQAP re-registration units: 16 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 2 March 2020: Member Rate $795, Non-member Rate $945, Student Rate $375
  • After 2 March 2020: Member Rate $855, Non-member Rate $1,005, 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

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 101: Understanding the Basics (2 Day)

Monday, 30 March 2020, 8:30 AM - Tuesday, 31 March 2020, 5:30 PM

RQAP re-registration units: 16.00 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 2 March 2020: Member Rate $795, Non-member Rate $945, Student Rate $375
  • After 2 March 2020: Member Rate $855, Non-member Rate $1,005, Student Rate $405
Description
This 2 day course will cover the evolution of GCP, applicable regulations & guidelines, GCP auditing of investigator sites & service providers, and applying what you have learned with interactive exercises. 

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
  • Familiarity with 21 CFR § 11, 50, 54, 56, 320 and ICH GCP (Regulation Book Provided
Target Audience
Quality Professionals with no GCP experience up to 1 year experience. This is a very basic course.

Agenda

TBD


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

Monday, 30 March 2020, 8:30 AM - 5:30 PM

RQAP re-registration units: 8.00 GCP, GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 2 March 2020: Member Rate $535, Non-member Rate $685, Student Rate $255
  • After 2 March 2020: Member Rate $595, Non-member Rate $745, 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 101: Basic Concepts in Computer Validation (2 Day)

Monday, 30 March 2020, 8:30 AM - Tuesday, 31 March 2020, 5:30 PM

RQAP re-registration units: 16.00 GCP, GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices
  • Before 2 March 2020: Member Rate $795, Non-member Rate $945, Student Rate $375
  • After 2 March 2020: Member Rate $855, Non-member Rate $1,005, Student Rate $405
Description
This course is designed for Validation, Quality, IT, and Business personnel responsible for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries. The course is of special value to personnel seeking experience with computer validation and issues associated with regulated computer systems. The course is especially designed for attendees seeking a thorough introductory level of understanding, yet is also designed to be valuable to those with prior experience seeking to remain current with industry trends and approaches.

Objectives
At the end of the course, the participants shall be able to: 
  • Provide a thorough understanding of computer system validation by providing a framework on how to execute the System Life Cycle.
  • Be familiar with expected content for computer validation deliverables through workshop exercises and examination of example documents, as well as how to develop the validation rationale for a variety of circumstances.
Target Audience
This course is designed for Validation, Quality, IT, and Business personnel responsible for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries. The course is of special value to personnel seeking experience with computer validation and issues associated with regulated computer systems. The course is especially designed for attendees seeking a thorough introductory level of understanding, yet is also designed to be valuable to those with prior experience seeking to remain current with industry trends and approaches.

Agenda
  • Understanding the Regulations and Guidelines.
  • Identifying the Components of the System Life Cycle.
  • In-depth look at the Validation Deliverable.
  • Planning, Conducting and Documenting the Computer Validation Audit.


5 — GCP 204: Quality Risk Management: What You Need to Know to Offer Effective Clinical Compliance Advice to Clinical Operations Teams

Monday, 30 March 2020, 8:30 AM - 5:30 PM

RQAP re-registration units: 8.00 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 2 March 2020: Member Rate $535, Non-member Rate $685, Student Rate $255
  • After 2 March 2020: Member Rate $595, Non-member Rate $745, Student Rate $285
Description - **This course requires a laptop**
The introduction of risk-based monitoring and clinical study quality risk management is affecting the role of the Clinical QA (CQA) auditor and management in many ways. This role is evolving to include compliance advice to clinical study teams from study design through study close-out. The Clinical QA role is becoming pivotal in the Quality by Design model. This course offers the Clinical QA professional an in depth look at those elements of ICH E6(R2), Sections 5.0.1 – 5.0.7, including the opportunity to participate in simulated risk assessment categorization, individual study quality risk management planning, study team compliance reviews, and practical tools for implementation of QRM.

Objectives
At the end of the course, the participants shall be able to: 
  1. Learn the purpose and components of the Risk Assessment Categorization Tool (RACT) for clinical studies.
  2. Learn the purpose and components of the Individual Quality Risk Management Plan (IQRMP) for clinical studies.
  3. Learn what goes into a good clinical study compliance review meeting and the role that the Clinical QA professional plays on the team.
  4. Use the information learned to offer timely and well-versed advice to clinical study teams during the development and implementation of the RACT, IQRMP, and study compliance review meetings.
Target Audience
Beginner, Intermediate, and Advanced GCP auditors and Clinical compliance associates

Agenda
8:00 – 10:00 am
Introduction to Speakers
Introduction to Course
Overview of Evolved Clinical QA role in clinical studies (not more than 15
minutes for intros and overview)

RACT: What is it? What are its components? What part(s) does the CQA
participate in? When does the CQA participate?

10:00 – 10:15 am Break

10:15 – 12 noon
IQRMP: What is it? What are its components? What part(s) does the CQA
participate in? When does the CQA participate?

12 noon – 1:00pm Lunch

1:00 – 2:45 pm
Overview of clinical study compliance review meeting and CQA’s role.
Practice development participation in RACT.
2:45 – 3:00 pm Break

3:00 – 5:00 pm
Complete practice development participation in RACT.
Practice development participation in IQRMP.
Close

6 — GCLP 101: An Introduction to Good Clinical Laboratory Practices (GCLPs) and navigating the complex landscape from a quality and business perspective.

Monday, 30 March 2020, 8:30 AM - 5:30 PM

RQAP re-registration units: 8.00 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 2 March 2020: Member Rate $535, Non-member Rate $685, Student Rate $255
  • After 2 March 2020: Member Rate $595, Non-member Rate $745, Student Rate $285
Description
An Introduction to Good Clinical Laboratory Practices (GCLPs) and navigating the complex landscape from a quality and business perspective. Topics will include the major guidance documents accreditations, regulations and other documents used within GCLP laboratories to guide the compliance, define elements of GCLP risk-based audit program, overview of the implementation and maintenance of GCLP guidelines from a laboratory management and operations perspective and the merits and demerits of current regulatory loophole and FDA’s effort at addressing the public health concern.

Objectives
At the end of the course, the participants shall be able to: 
  • Review and discuss the major guidance documents accreditations, regulations and other documents used within GCLP laboratories to guide the compliance, including Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs,) Part 11, European Medicines Agency (EMA) GCLP, CLIA, Division of Aids (DAIDS), Research Quality Association RQA, CAP and World Health Organization (WHO).
  • Define elements of a GCLP risk-based audit program from a sponsors perspective, development of an annual audit plan, preparation of a GCLP Audit scope and agenda for internal/external audits and preparation and what to expect from an audit/certification/regulatory inspection.
  • Overview of the implementation and maintenance of GCLP guidelines from a laboratory management and operations perspective. From a practical application standpoint, an overview of what a GCLP laboratory looks and functions like and summarize key topics that must be implemented in a GCLP laboratory.
  • Clinical laboratories in the US, where assays are developed and used for research purposes only (RUO) do not always follow or subscribe to CLIA regulations and existing GCLP guidelines. The objective of this course is to help the learner understand the nature of such research where results from testing clinical samples often end up in regulatory submissions. This course should give the learner an idea of what exists in the current regulatory landscape to support such testing. The course will also touch upon special cases where these regulations do not apply, and, in such cases, how to ensure that the data from such laboratories are submission-ready.
Target Audience
Anyone interested in GCLPs

Agenda

  1. Introduction and greeting – 45 minutes
  2. Introduction to basic GCLP guidelines- 1 hour
  3. Risk Management and Regulatory Inspections - 1.5 hours
  4. Overview of the implementation and maintenance of GCLP guidelines from a laboratory management and operations perspective -1.5 hours
  5. Special Cases in GCLPs - 1.5 hours
  6. In class exercise – 1 hour

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

Tuesday, 31 March 2020, 8:30 AM - 5:30 PM

RQAP re-registration units: 8.00 GCP, GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices

  • Before 2 March 2020: Member Rate $535, Non-member Rate $685, Student Rate $255
  • After 2 March 2020: Member Rate $595, Non-member Rate $745, 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

8 — GCP 201: Hot Topics & Industry Trends

Tuesday, 31 March 2020, 8:30 AM - 5:30 PM

RQAP re-registration units: 8.00 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 2 March 2020: Member Rate $535, Non-member Rate $685, Student Rate $255
  • After 2 March 2020: Member Rate $595, Non-member Rate $745, Student Rate $285
Description

The Hot Topics and Industry Trends workshop focuses on emerging technology, best practices and the changing regulatory environment in an effort to help Clinical QA professionals focus forward and develop skills to be successful as the clinical research landscape evolves. This offering will focus on a Case Study presented by USFDA BIMO personnel, successful vendor management in line with ICH E6(R2) expectations, the role of the IRB beyond study/document approval and how emerging technologies such as machine learning, artificial intelligence and block chain are being used in clinical research, what QA professionals may need to know about these technologies.

Objectives
At the end of the course, the participants shall be able to: 
  1. Describe at least 3 important factors for successful Vendor Management in compliance with expectations from the ICH E6(R2) Guideline
  2. Discuss important trends in technology, such as Artificial Intelligence, Block Chain and Machine Learning which are impacting clinical research that QA auditors will need to understand in order to effectively manage the risks associated with such technologies
  3. Share insights from USFDA Case Study presentations

Target Audience
Clinical QA auditors with at least 2 years experience.

Agenda

  • E6(R2) Vendor Management Expectations and Best Practices (Pam Dellea-Giltner)
  • FDA BIMO Case Study (Chrissy Cochran)
  • Quality Management from an FDA Perspective (Erik Pittman) OR eSource Direct Data Capture (Glenda Guest)
  • Important Considerations for Emerging Technologies such as AI, Block Chain and Machine Learning in Clinical Research (David Vulcano)
  • Root Cause Analysis and CAPA presentation and exercise (Lee Truax-Bellows)

9 — GMP 101: Basic Training: GMP History and Regulations

Tuesday, 31 March 2020, 8:30 AM - 5:30 PM

RQAP re-registration units: 8.00 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 2 March 2020: Member Rate $535, Non-member Rate $685, Student Rate $255
  • After 2 March 2020: Member Rate $595, Non-member Rate $745, Student Rate $285
Description
This course provides a history of the GMP regulations, what is the purpose, why were they created, how did they develop over time and an overview of the sections of the regulations.

Objectives
At the end of the course, the participants shall be able to:  
Understand the purpose of the GMP regulations, how the regulations developed over time, provide an overview of the regulations.

Target Audience
Quality Assurance professionals and management looking for an overview of the GMP regulations.

Agenda
  • History and Introduction of the US FDA GMPs
  • Overview of 21 CFR Parts 210 and 211
  • Quality Systems Overview
  • SOPs
  • Out of Specification
  • Are You Ready
  • GLP QA vs. GMP QA
 

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

Tuesday 31 March 2020, 8:30 AM - 12:30 PM

RQAP re-registration units: 4.00 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 2 March 2020: Member Rate $305, Non-member Rate $405, Student Rate $145
  • After 2 March 2020: Member Rate $365, Non-member Rate $465, 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: 
  1. learn the history behind the FDA GLP regulations
  2. learn the correlation between the initial fraud, regulations, and Guidance Manual
  3. learn how to apply the GLPs to situations at their local labs
  4. 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
  1. History prior to 1970s
  2. Searle Pharmaceutical, Searle Task Force
  3. Industrial Bio-Test Lab
  4. Monsanto
  5. Hazleton Lab
  6. Congressional hearing, Bressler Report
  7. Regulatory action, IBT Trial
  8. Practical exercises to write robust audit findings by applying history learnings to specific situations

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

Tuesday, 31 March 2020, 1:30 PM - 5:30 PM

RQAP re-registration units: 4.00 GCP, GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices
  • Before 2 March 2020: Member Rate $305, Non-member Rate $405, Student Rate $145
  • After 2 March 2020: Member Rate $365, Non-member Rate $465, Student Rate $175

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 the course, the participants shall 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
10min - Introductions and Course Overview
40min plus 5 min Q&A - Data Integrity and Regulatory Requirements Overview
10min - Paper Records Compared to their Electronic Audit Trail Equivalent
20min plus 5 min Q&A - Managing the Audit Trail Review Process (Topics covered include: who reviews them, where is this process defined, where do the audit trails go, how to manage extensive audit trails)
20min plus 5 min Q&A - System Logs vs. Audit Trails
20min - Group work – Review of example audit trails and discussion
15min - BREAK
25min - Group Work – Review of example audit trails and discussions (continued)
30min 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)
20min - Individual Work – Mock inspection and report on examples provided using electronic audit trails
30min - Discuss specific issues and questions submitted at the time of registration/Open Discussion

12 — General 104: The Three Cs of SOPs: Clear, Concise, and Compliant in a Regulatory Setting

Friday, 3 April 2020, 1:30 PM - 5:30 PM

RQAP re-registration units: 4.00 GCP, GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices
  • Before 2 March 2020: Member Rate $305, Non-member Rate $405, Student Rate $145
  • After 2 March 2020: Member Rate $365, Non-member Rate $465, Student Rate $175
Description
This course will cover the full life-cycle of controlled process documents -- from creation through archival. Topics will also include responsibilities, training, and non-compliance. Attendees should be prepared to bring examples of questions relating to SOPs (controlled process documents) and SOP management.

Objectives
At the end of the course, the participants shall be able to:  
  • Understand the purpose and benefit of effective SOPs.
  • Understand the critical role of SOPs in Quality Documentation systems.
  • How to write a concise, unambiguous SOP for its intended purpose.
  • Define clear responsibilities to promote action and closure within the document.
  • Training requirements.
  • Manage revisions, nonconformance and deviations from a current SOP.
  • Difference between GCP/GLP/GMP with regard to SOPs and how they are used.
Target Audience
Anyone responsible for the life cycle and compliance of these key components of the Quality Management System. This course is applicable to GMP, GCP, GLP and GVP -- both beginners and more experienced 

Agenda
  • 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
  • SQA Specialty Section-sponsored

14 — New Skills for Quality Assurance Professionals

Friday, 3 April 2020, 1:30 PM - 5:30 PM

RQAP re-registration units: 4.00 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 2 March 2020: Member Rate $305, Non-member Rate $405, Student Rate $145
  • After 2 March 2020: Member Rate $365, Non-member Rate $465, Student Rate $175
Description
The future is arriving faster than we think! Automation, AI and algorithms are here, and Quality Assurance should evolve and adapt to continue to add value in our ever-changing environment. This course is an interactive reflection on the skills that QA will need to thrive, both now and over the coming decades.

Objectives
At the end of the course, the participants shall be able to: 
  1. Introduce material describing future scenarios for business in general, and for the role of quality professionals.
  2. Use this material to define a set of competencies and skills that will be increasingly sought after in the future.
  3. Describe, with examples, how these skills can add value to the QA role.
  4. Provide guidance on some of the technology that is available to support evolving roles and competencies
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
1. The future: insights from recent surveys and articles. The future of quality and
quality assurance, Quality 4.0.
2. A framework for development: which skills will add most value now and in the
future?
Systems: systems thinking, QMS 3.0, new scientific paradigms
Data: transforming data into information, knowledge and insight.
Models/Tools: useful models and tools to develop and support new skills
3. Effectiveness and Efficiency: creating the space to change and develop.

13 — General 101: QA Consulting

Friday, 3 April 2020, 1:30 PM - 5:30 PM

RQAP re-registration units: 4.00 non-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 2 March 2020: Member Rate $305, Non-member Rate $405, Student Rate $145
  • After 2 March 2020: Member Rate $365, Non-member Rate $465, Student Rate $175
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.
Objectives
At the end of the course, the participants shall be able to: 
  1. Develop ideas for setting up and running a consulting practice.
  2. Weigh the pros and cons of different types of legal and tax options.
  3. Learn sponsor's (your client) expectations, needs and methods of interactions.
  4. Understand what laboratories/CROs expect from you.
Target Audience
This course is targeted for those QA professionals who want to learn more about consulting or have 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 good QA Consultant

15 — GLP 103: Basic GLP Archiving

Friday, 3 April 2020, 1:30 PM - 5:30 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 2 March 2020: Member Rate $305, Non-member Rate $405, Student Rate $145
  • After 2 March 2020: Member Rate $365, Non-member Rate $465, Student Rate $175
Description
This course answers the who, what, when, where, why, & how of archiving (both physical and electronic) and associated processes.
Objectives
At the end of the course, the participants shall be able to: 
  1. The basics of GLP Archiving Electronic record archiving
  2. The basics of GLP Archiving Electronic record archiving
Target Audience
This course would be aimed at new GLP auditors or those newly responsible for establishing and/or maintaining a GLP archive.

Agenda
TBD

16 — GLP 104: Auditing Techniques

Saturday, 4 April 2020, 8:30 AM - 5:30 PM

RQAP re-registration units: 8.00 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 2 March 2020: Member Rate $535, Non-member Rate $685, Student Rate $255
  • After 2 March 2020: Member Rate $595, Non-member Rate $745, Student Rate $285
Description
This course is a comprehensive introduction to auditing GLP study data, final reports and facility records, utilizing data from a mock in vitro study. The course will incorporate how to effectively communicate and resolve audit observations. Opportunities for group interaction, group exercises, and discussion will help to enhance the learning process.
Objectives
At the end of the course, the participants shall be able to: 
  1. Understand the regulatory requirements for GLP QA
  2. Understand regulatory inspection process for nonclinical laboratory facilities, including a review of the Bioresearch Monitoring Program (BIMO) Compliance Program Guidance Manual (CPGM)
  3. Effectively communicate FDA GLP requirements to management and study personnel
  4. Audit laboratory records, electronic data and final reports for compliance with regulations
  5. Identify compliance gaps and effectively communicate gaps and recommendations for correction via an audit report
  6. 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
  6. Facility Records
  7. Electronic Records
  8. Study Data (including electronic data, and audit trails)
  9. Report Audit
  10. Writing and Resolving Audit Reports
  11. Quality Assurance Statements
  12. Conducting Internal Facility and External Vendor Audits
  13. Hosting Sponsor/Regulatory Audits

17 — General 106: Auditor's Primer on the Science, Practice, and Auditing of Chromatography and Mass Spectrometry

Saturday, 4 April 2020, 8:30 AM - 5:30 PM

RQAP re-registration units: 8.00 GLP, GCP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices
  • Before 2 March 2020: Member Rate $535, Non-member Rate $685, Student Rate $255
  • After 2 March 2020: Member Rate $595, Non-member Rate $745, Student Rate $285
Description

Chromatographic and mass spectrometric analyses provide critical data for many pharmacokinetic, dose analysis, safety, efficacy, and absorption, distribution, metabolism, and excretion (ADME) studies. Therefore, it is imperative that quality assurance professionals possess the knowledge and skills to properly audit this type of data. This course contains two distinct, but complimentary sessions.

The morning session covers the theory and practice of high performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC), gas chromatography (GC), and mass spectrometry (MS). We will discuss auditing techniques, system suitability testing, incurred sample reanalysis (ISR), and failure investigation.

The afternoon session uses a problem based learning (PBL) approach to enhance and hone the quality assurance professional’s skills for auditing chromatographic and mass spectrometric data. Participants will be placed into small teams and provided an example data and report packet to audit. We will then discuss the findings as a class. By combining background theory, practice, and applications with hands-on PBL, this course provides an all-around approach to auditing chromatographic and mass spectrometric analyses.


Objectives
At the end of the course, the participants shall be able to: 
  • Identify different chromatographic techniques, their basic theory, and applications in a bioanalytical laboratory
  • Discuss mass spectrometry, its theory and applications
  • Define key chromatographic and mass spectrometry terms
  • Provide guidance on failure investigations
  • Use their newly gained understanding to better audit small molecule bioanalytical data
Target Audience
This course is for any quality assurance professional interested in understanding the science and auditing skills of bioanalytical chromatography and mass spectrometry. It will also over incurred sample reanalysis and conducting failure investigations. This course is intended for beginner to intermediate level quality assurance professionals.

Agenda
  • Background (history) and types of chromatography
  • Theory and practice of HPLC/UPLC/GC
  • Theory and practice of mass spectrometry
  • Incurred Sample Reanalysis (ISR)
  • Failure investigations
  • Lunch break
  • Auditing chromatographic data
  • Auditing mass spectrometry data
  • Problem Based Learning, Hands-On Exercise

18 — GCP 301: Advanced GCP

Saturday, 4 April 2020, 8:30 AM - 5:30 PM

RQAP re-registration units: 8.00 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 2 March 2020: Member Rate $535, Non-member Rate $685, Student Rate $255
  • After 2 March 2020: Member Rate $595, Non-member Rate $745, Student Rate $285
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 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 2 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 - Lee Truax-Bellows

8:30 - 9:15
Components of a Quality Management System (QMS) and its Application Within QA - Glenda Guest

9:15 - 10:00
FDA’s Approach to a Quality Management System Approach in GCPs - Chrissy Cochran

10:00 – 10:15 Break

10:15 – 11:00
Additional Strategies for Planning, Conducting and Reporting Audits Under a QMS Approach - Cheryl McCarthy

11:00 – 12:00
European Union’s Approach to the Inspection Process - Speaker Pending

12:00 – 1:00 Lunch

1:00 – 2:30
GCP Risk Management, Root Cause Analysis & CAPA Under QA - Lee Truax-Bellows

2:30 – 3:15
Collecting and Assessing QA Metrics - Speaker Pending

3:15 – 3:30 Break

3:30 - 4:30
Interview Techniques - Glenda Guest

4:30 – 5:00 Q&A - All

19 — General 201: Systems Thinking in Quality Management

Saturday, 4 April 2020, 8:30 AM - 5:30 PM

RQAP re-registration units: 8.00 GCP, GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Prices
  • Before 2 March 2020: Member Rate $535, Non-member Rate $685, Student Rate $255
  • After 2 March 2020: Member Rate $595, Non-member Rate $745, Student Rate $285
Description
The intention of the course is to enhance the effectiveness of the QA auditor's own activities and interactions in QA with peers, colleagues and auditees and to develop and refine QA competence beyond the training of GXP regulatory requirements. The course will consist of short presentations/briefings and discussions, case studies, workshops and exercises where participants are invited to contribute. Participants must be able to communicate fluently in English.
Objectives
At the end of the course, the participants shall be able to: 
  • Understand key features of systems thinking and how they are related to Quality Management.
  • Have a selection of new tools and techniques for achieving quality outcomes and building an effective QA function in partnership with their organization.
  • Identify activities that will provide the key to future professional and personal development.
Target Audience
GXP professionals with some experience in QA (ideally 3 or more years), who wish to learn about new topics related to Quality Management and QA in particular systems thinking tools and techniques, enhance professional and personal growth and their contribution towards a quality organization

Agenda
1. The Status Quo
1a. Where are we in QA? What's our role?
1b. What are the expectations?
1c. What keeps us busy?
2. Broadening the Perspective: Systems Thinking and more
2a. Key Features of Systems Thinking
2b. Systems Thinking and Quality Management - how to combine?
2c. More Ideas from Cybernetics, Psychology and Management
3. Putting the new Tools and Ideas to Use
3a. Clarifying the Personal Vision
3b. Understanding Mental Models
3c. Building a Shared Vision
3d. Learning as a Team
4. Engaging to add Value
4a. The Learning Organization
4b. New Roles for QA: Designer, Facilitator, Teacher, Coach

20 — Archiving 201: Beyond a GLP-compliant archiving function

Saturday, 4 April 2020, 8:30 AM - 12:30 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 2 March 2020: Member Rate $305, Non-member Rate $405, Student Rate $145
  • After 2 March 2020: Member Rate $365, Non-member Rate $465, Student Rate $175
Description
Archiving 201 will dive more into the current and future state of electronic data archiving, records management and shipping/disposing regulated materials.
Objectives
At the end of the course, the participants shall be able to: 
  • Advanced understanding of electronic systems and e-data archiving.
  • Current and anticipated future state of Archiving
  • Records Management and Archiving
Target Audience
Intermediate to advance level individuals responsible for GLP archiving.

Agenda
  • Archiving electronic records
  • Moving an archive (shipment and disposal of regulated records)
  • Records management
  • Regulatory landscape

21 — General 102: SQA Leadership Development

Friday, 3 April 2020, 12:30 AM - 5:30 PM

RQAP re-registration units: 4.00 non-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 2 March 2020: Member Rate $305, Non-member Rate $405, Student Rate $145
  • After 2 March 2020: Member Rate $365, Non-member Rate $465, Student Rate $175
Description
The SQA Board of Directors has created this course for SQA members. This course is designed to provide SQA members with tools and skills that will enable them to be better leaders in both SQA volunteer leadership positions as well as in other areas of their lives. It will provide a better understanding of SQA leadership responsibilities and an understanding of how SQA is governed. SQA members who are considering running for election or volunteering on Committees or within Specialty Sections will gain a better understanding of the requirements and responsibilities of the positions and the resources and assistance SQA offers to support those positions;. It will also provide an opportunity to meet and network with past, current and future SQA leaders and to develop and discuss leadership concepts through fun group exercises.
Objectives
At the end of the course, the participants shall be able to: 
  • Describe how to attract appropriate volunteers and how to get them actively involved.
  • Discuss methods of motivating and rewarding volunteers.
  • Describe how various leadership activities are linked to the SQA strategic plan.
  • Implement effective leadership transition (when leaving a leadership position) so that progress can continue.
  • Demonstrate practical and effective communication techniques.
  • Identify who to ask for help with SQA leadership activities.
  • Use the SQA website to effectively lead and manage committees, specialty sections and/or other ad hoc groups and subcommittees within SQA.
  • Use SQA Headquarters services to minimize workload and maximize results.
Target Audience
This course is directed at SQA members who wish to become further involved with SQA in a leadership capacity, are considering becoming a future SQA leader or wish to further develop or gain knowledge of leadership skills.

Agenda
Why
What
How (exercises)
If (panel)
Volunteers: what are they and why are they important
Finding appropriate volunteers
Why volunteer – WIIFM
Motivating and empowering volunteers
Leading long-distance committees
Goal planning
Determining and retaining members
How to inspire, delegate, motivate, assign tasks, follow-up on tasks
Fine art of delegation
Transition of volunteers/chair
Evaluating how you are doing
Thank you notes
EXERCISE: Communication
Aligning with the SQA Strategic Plan
Minutes and reports
Website use
SQA conference lines
Maintaining membership list (Volunteer Commitment Form)
EXERCISE: Game
Current Leader Panel/Q & A
(5 min personal story from panelists)