April/May 2019 Quality College Course Descriptions




1 — GLP 101: Basic Training (2 Days)

Sunday, 28 April 2019, 8:00 AM - Monday, 29 April, 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 $745, Non-member Rate $895, Student Rate $375
  • After 29 March 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 and suggest improvements based upon regulatory requirements;
    Effectively communicate the requirements of FDA GLPs and identify topical differences between FDA and EPA requirements and OECD Principles of GLP;
  • Interpret and apply GLP requirements using a variety of resources;
  • Use the knowledge obtained by completing the training exercises to increase effectiveness in current role


Target Audience
This course is a comprehensive introduction to FDA Good Laboratory Practice regulations or refresher training for all personnel involved in a nonclinical laboratory study. 


Agenda
1:  Basic GLP Training Overview
2:  Landmark Cases in the Development of GLP
3:  Organization of the GLP Regulations
4:  Scope and Definitions
5:  Contracting Under GLPs and Inspections of Testing Facilities
6:  Organization and Personnel
7:  Facilities
8:  Equipment
9:  Testing Facilities Operation
10:  Test and Control Articles
11:  The Protocol
12:  Conduct of Nonclinical Laboratory Studies
13:  Reporting of a Nonclinical Laboratory Study
14:  Storage, Retrieval, and Retention
15:  Electronic Record Keeping in Nonclinical Laboratory Studies
16:  Shall vs. Should
17:  FDA/EPA Regulations vs. OECD Principles of GLP
 


2 — GCP 101: Understanding the Basics

Sunday, 28 April 2019, 8:00 AM - Monday, 29 April, 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 $745, Non-member Rate $895, Student Rate $375
  • After 29 March 2019: Member Rate $805, Non-member Rate $955, 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
  • 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) 

 



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

Sunday, 28 April 2019, 8:00 AM - 5:00 PM

RQAP re-registration units: 1 GCP or non-GLP

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

Prices

  • Before 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
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 (1 Day)

Sunday, 28 April 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
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.
  • 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 — Vet 101: Veterinary GCP Basics (1 Day)

Sunday, 28 April 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
The Animal Health Specialty Section (AHSS) of SQA is sponsoring a Veterinary Good Clinical Practice (vGCP) training course for animal health professionals interested in VICH (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products) GCP. VICH is a trilateral (EU-Japan-USA) program aimed at harmonizing technical requirements for veterinary product registration. This course is designed as an introductory or refresher course that will cover the basic elements. The course will be team taught and will include representation from various companies.

Objectives
At the end of the course, the participants shall be able to: 
  • Identify the roles of the clinical investigator, monitor, and sponsor and their responsibilities
  • Identify the differences between monitoring and quality assurance
  • Follow data from collection to submission and identify data integrity risks
  • Identify the differences between companion animal and production animal studies.
  • Identify the legal links between the vGCP guidance documents and US regulations.

Target Audience
Animal health professionals (Clinical Investigators, Quality Assurance, Sponsors, Monitors, Regulatory Affairs) interested in veterinary Good Clinical Practice. The course will provide an overview of the basics.


Agenda

AM
  • Investigator Responsibilities
  • Monitor Responsibilities
  • Quality Assurance in vGCP Studies
  • Sponsor Responsibilities
  • 21 CFR 511 and 514 and Regulatory Inspections
PM
  • Production vs Companion Animal Studies
  • Protocols
  • Raw Data
  • Final Study Reports


6 — PV 201: Intermediate Pharmacovigilance Auditing (2 Day)

Sunday, 28 April 2019, 8:00 AM - Monday, 29 April, 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 $745, Non-member Rate $895, Student Rate $375
  • After 29 March 2019: Member Rate $805, Non-member Rate $955, Student Rate $405

Description

This is a two day intermediate pharmacovigilance auditing course. The participant will learn how to assess PV Risk for Annual Audit Planning, understand the elements of the Safety Data Exchange Agreement, and QA's role in the PSMF, as well as other topics. 
Several breakout sessions and hands on activities will include PV audit preparation including developing the scope and agendas for various types of PV audits. Some role play will be included. The participants will also be given real life audit observations and be asked to review and assess the criticality of the observations.


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

  • Define elements of PV Risk for the PV annual audit plan
  • Prepare a general PV Audit Scope and Agenda
  • Determine the four elements of a reportable Adverse Event
  • Define the role of QA in relation to the company PSMF
  • Identify the top five elements necessary to have within a Safety Data Exchange Agreement


Target Audience

Auditors that have at minimum completed the electronic Basic PV course provided by SQA. Some prior PV audit experience would be beneficial.


Agenda
DAY 1

  • Trends in PV inspections (MHRA, EMA, FDA timeframe between 2014 - 2017)
  • Internal Risk Assessments for PV Audit Planning
  • Activity: PV Audit Planning: Preparation, Scopes, Agendas
  • QA's Role in the PSMF
  • Required Elements in Safety Data Exchange Agreements
  • Aggregate Reporting
DAY 2

  • Understanding cases: Causality, Coding, Labeling - questions/answers within the slides
  • Activity: PV Audit Checklist - work through specific audit scope topics
  • Post Authorization Safety Studies - what are they and what to audit
  • Risk Mitigation - how to asses if they are working
  • Activity: Audit Observations - review & assess real life observations


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

Monday, 29 April 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
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 — Vet 201: Veterinary GCP Intermediate Topics

Monday, 29 April 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

The Animal Health Specialty Section (AHSS) of SQA is sponsoring a Veterinary Good Clinical Practice (vGCP) training course for animal health professionals interested in VICH (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products) GCP. VICH is a trilateral (EU-Japan-USA) program aimed at harmonizing technical requirements for veterinary product registration. This course is designed to provide detailed instruction and opportunity for discussion on specific current hot topics. The course will be team-taught and will include representation from various companies.

Objectives
At the end of the course, the participants shall be able to: 
  • Identify aspects of effective monitoring with a focus on clinical site management
  • Identify the need for quality assurance in vGCP studies.
  • Identify raw data and data integrity gaps in electronic data capture systems
  • Identify the focus of regulatory authorities when they inspect clinical sites and sponsors associated with vGCP studies
  • Identify the current pitfalls in submissions and how to avoid them

Target Audience

Animal health professionals (Clinical Investigators, Quality Assurance, Sponsors, Monitors, Regulatory Affairs) interested in veterinary Good Clinical Practice. The course complements the course "Veterinary Good Clinical Practices (vGCP) - Basics" and will provide more detailed instruction.

Agenda

  • Monitoring
  • Quality Assurance
  • Bioresearch Monitoring
  • Electronic Data Capture
  • Submissions
  • General Topics


9 — GCP 202: Hot Topics & Industry Trends (1 Day)

Monday, 29 April 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
This interactive workshop will bring together several subject matter experts to explore hot topics and industry trends in addressing current challenges in the GCP environment. This is a highly interactive workshop with interactive group exercises to help you apply the concepts covered during brief lectures and discussions. Late breaking GCP topics may be added as applicable.

Objectives
At the end of the course, the participants shall be able to:  
  • Describe how FDA using data to quantify risk to determine where to conduct site inspections.
  • Discuss DRAFT REMS Guidance and Auditing Techniques.
  • Explain literature search techniques.
  • Understand the potential impacts of Block Chain technology on the clinical research environment.
  • Correctly respond to 483 observations now that District Offices have been eliminated.

Target Audience
GCP Professionals with 2+ years of experience

 

Agenda
  • REMS Guidance and Auditing Tips
  • Literature Search Techniques
  • Block Chain-The Potential Impact on Research
  • ICHE6(R2) - Using data to assess and manage risk, monitor safety and ensure data reliability
  • FDA Re-organization Update


10 — Quality Assurance professionals and management looking for an overview of the GMP regulations (1 Day)

Monday, 29 April 2019, 8:00 AM - 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 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

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
This training is ideal for personnel that:
Quality Assurance professionals and management looking for an overview of the GMP regulations

Agenda
  • History and Introduction of the US FDA GMPs
  • Overview of 21CFR Parts 210 and 211
  • Quality Systems Overview
  • SOPs
  • Out of Specifications
  • Are you Ready
  • GLP QA versus GMP QA

 


11 — GLP 103: Basic GLP Archiving (1/2 Day)

Thursday, 2 May 2019, 1:30 PM - 5:30 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 $285, Non-member Rate $385, Student Rate $145
  • After 29 March 2019: Member Rate $345, Non-member Rate $445, Student Rate $175

Description

Archiving 101 is a course designed to educate current and upcoming archivists on the basics of the regulations and industry expectations with regards to GLP archiving. Points to consider will include the basics of the regulations to the current state of archiving, electronic data and electronic systems.

Objectives
At the end of the course, the participants shall be able to: 
  • Archivist will be able to highlight regulatory expectations
  • Understand the basics of Archiving
  • The current and future state of electronic data archiving
Target Audience
Beginners to GLP archiving. Course is ideal for upcoming/current archivists, or those considering the role.

Agenda
  • The basics of GLP archiving
  • Auditing an archive (understanding the regulations and pitfalls)
  • Electronic Data Archiving


  • 12 — General 102: SQA Leadership Development

    Thursday, 2 May 2019, 1:30 PM - 5:30 PM

    RQAP re-registration units: 1 non-GCP or non-GLP

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

    Prices

    • Before 27 August 2018: Member Rate $285, Non-member Rate $385, Student Rate $145
    • After 27 August 2018: Member Rate $345, Non-member Rate $445, 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
    • Volunteers: what are they and why are they important
    • Finding appropriate volunteers
    • Finding appropriate volunteers
    • 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
    • Aligning with the SQA Strategic Plan
    • Minutes and reports
    • Website use
    • Maintaining membership list (Volunteer Commitment Form)
    • Jeopardy
    • Current Leader Panel/Q & A


    13 — GLP 102: Lies and Deceit: History Behind the FDA GLPs (1/2 Day)

    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

    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 $285, Non-member Rate $385, Student Rate $145
    • After 29 March 2019: 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,ul>
  • 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



  • 14 — GLP 203: Intermediate GLP Archiving (1/2 Day)

    Friday, 3 May 2019, 8:00 AM - 12:00 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 $285, Non-member Rate $385, Student Rate $145
    • After 29 March 2019: Member Rate $345, Non-member Rate $445, 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
    • Moving/Decommissioning an archive
    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


    15 -GLP 104: Auditing Techniques (1 Day)

    Friday, 3 May 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 $72, 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: 
    • Understand the regulatory requirements for GLP QA
    • 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 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 a FDA Good Laboratory Practice facility.

    Agenda
    1. Course Overview
    2. Quality Assurance Responsibilities
    3. CPGM Overview
    4. Protocol Audits
    5. SOP Review
    6. Process and Phase Inspections
    7. Study Data (including deviations/unforeseen circumstances, electronic data, and audit trails)
    8. Report Audit
    9. Developing Audit Observations and Resolving Audits
    10. Quality Assurance Statements
    11. Facility Records
    12. Training Files


    16-General 106: Auditor's Primer: Chromatography & Mass Spec
    Friday, 3 May 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

    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 cover 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
    • Auditing chromatographic data
    • Auditing mass spectrometry data
    • System suitability
    • Incurred Sample Reanalysis (ISR)
    • Failure investigations
    • Lunch Break
    • Problem Based Learning, Hands-On Exercise



    17-GCP 201: Advanced Training
    Friday, 3 May 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

    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.
    • Discuss mass spectrometry, its theory and applications
    • The attendee shall be able incorporate current regulations and guidelines that impact GCP into their roles.
    • Provide guidance on failure investigations
    • The attendee shall be able to understand and implement a quality management system approach into their roles./li>
    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
    • 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 Additional Strategies for Planning, Conducting and Reporting Audits Under a QMS Approach
    • 12:00 - 1:00 Lunch
    • Lunch Break
    • 1:00 - 2:00 Practical Application of a Quality Management System (QMS) Approach within the GCP Arena
    • 2:00 - 3:00 GCP Risk Management
    • 3:00 - 3:15 Break
    • 3:15-4:30 Root Cause Analysis and CAPA Under GCPs
    • 4:30 - 5:00 Q&A



    18-General 201: Systems Thinking in Quality Management
    Friday, 3 May 2019, 8:00 AM - 12:00 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

    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) to enhance professional and personal growth and help foster 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



    19-General 104: Three Cs of SOPs
    Friday, 3 May 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

    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