March 2017 Quality College Course Descriptions






1 — Basic Training: Good Laboratory Practice (2 Days)


Sunday, 26 March 2017, 8:00 a.m. - Monday, 27 March 2017, 5:00 p.m.

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

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

Speakers

Colin Brown, Charles River Laboratories

Theresa Donegan, MS, RQAP-GLP, Shire

Gregory Furrow, Southern Research Institute

Beth Moulaison, Vertex

Barb Munch, GlaxoSmithKline

Steven Orr, Southern Research Institute

Thomas Purdue, RQAP-GLP, Boehringer Ingelheim Pharmaceuticals, Inc

Sara Rybak, RQAP-GLP, Charles River Laboratories

Gina Tucker, RQAP-GLP, Southern Research Institute

Lori Wright, RQAP-GLP, Charles River Laboratories

Prices

  • Before 27 February 2017: Student Member Rate $375, Member Rate $745, Non-member Rate $895
  • After 27 February 2017: Student Member Rate $405, Member Rate $805, Non-member Rate $955

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. 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
  • Basic GLP Training Overview
  • Landmark Cases in the Development of GLP
  • Organization of the GLP Regulations
  • Scope and Definitions
  • Contracting Under GLPs and Inspections of Testing Facilities
  • Organization and Personnel
  • Facilities
  • Equipment
  • Testing Facilities Operation
  • Test and Control Articles
  • The Protocol
  • Conduct of Nonclinical Laboratory Studies
  • Reporting of a Nonclinical Laboratory Study
  • Storage, Retrieval, and Retention
  • Electronic Record Keeping in Nonclinical Laboratory Studies
  • Shall vs. Should
  • FDA/EPA Regulations vs. OECD Principles of GLP


2 — Good Clinical Practice: The Basics (2 Days)

Sunday, 26 March 2017, 8:00 a.m. - Monday, 27 March 2017, 5:00 p.m.

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

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

Speakers

Anthony Scott Brewer, MBA, INC Research

Jacqueline Bushong, RQAP-GCP, Atara Biotherapeutics, Inc

Jamie Colgin, CISA, CRISC, ASQ CQA, Colgin Consulting Inc

Ni Khin, MD, US Food and Drug Administration

Jenny O'Brien, PhD, RQAP-GCP, OBrien CQA, LLC


Prices

  • Before 27 February 2017: Student Member Rate $375, Member Rate $745, Non-member Rate $895
  • After 27 February 2017: Student Member Rate $405, Member Rate $805, Non-member Rate $955

Description
This is a basic course providing an overview of the fundamentals of Good Clinical Practice. Some applied knowledge is provided through exercises, but advanced concepts are not within the scope of this training. 

Objectives
At the end of the course, the participants shall be able to: 
  • Define Good Clinical Practices
  • Cite key events impacting the evolution of GCP
  • Be familiar with 21 CFR §11,50, 54, 56, 320, and ICH GCP (book provided)
  • Learn how to prepare for a GCP audit
  • Describe 3-5 Activities to be performed during an audit


Target Audience
GCP Auditors with 0 to one year experience. Anyone who would like to learn the basics of GCP. This is a basic course. 


Agenda
  • Welcome: housekeeping, agenda review, and introductions
  • History and Principles of Good Clinical Practice
  • GCP Regulations and Guidelines
  • Clinical Study Roles and Responsibilities
  • Life Cycle of a Clinical Trial & Essential Documents
  • The Informed Consent Process
  • Safety Reporting - The Basics
  • Investigational Product Accountability
  • 21 CFR § 11 for Beginners
  • Hosting Audits and Inspections
  • SOPs and Internal Process Audits
  • Auditing Vendors for GCP Compliance
  • Investigator Site Audits
  • FDA Regulation of Clinical Studies
  • Audit Exercise
  • Panel Q&A
  • Closing Comments


3 — Basic Concepts in Computer Validation (2 Days)

Sunday, 26 March 2017, 8:00 a.m. - Monday, 27 March 2017, 5:00 p.m.

RQAP re-registration units: 4 GCP or GLP

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


Speakers

Randall Basinger, QuintilesIMS

Natalie Custer, Medpace, Inc.

Michelle Edwards, Charles River Laboratories

Joseph Franchetti, JAF Consulting Inc

Pat Miller, Seqirus, Inc.

Richard Siconolfi, MS, Procter & Gamble

Joseph Whittemore, Pfizer Inc

Prices

  • Before 27 February 2017: Student Member Rate $375, Member Rate $745, Non-member Rate $895
  • After 27 February 2017: Student Member Rate $405, Member Rate $805, Non-member Rate $955

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.
  • Address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process.
  • 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.


4 — Implementing a GLP Quality System in a University Setting (2 Days)

Sunday, 26 March 2017, 8:00 a.m. - Monday, 27 March 2017, 5:00 p.m.

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

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

Speakers

Shawn Bengtson, RQAP-GLP, University of Pittsburgh - McGowan Institute

Debra Bridges, RQAP-GLP, GLP Consulting Services

Prices

  • Before 27 February 2017: Student Member Rate $375, Member Rate $745, Non-member Rate $895
  • After 27 February 2017: Student Member Rate $405, Member Rate $805, Non-member Rate $955

Description
Academic institutions have traditionally had a high rate of noncompliance with the GLP regulations. Competition of research funding and increasing expectations for public/private partnerships from funding agencies have increased the demand for institutions that can conduct GLP studies or provide GLP compliant services. In this interactive workshop participants will identify compliance challenges and GLP opportunities, discuss strategies to evaluate institutional interest and readiness, and learn ways to overcome challenges in implementing and maintaining a GLP quality system at their institutions. 

Objectives
At the end of the course, the participants shall be able to: 
  • Identify common challenges in implementing & maintaining a GLP quality system in a university
  • Learn key ingredients in developing a GLP quality system in a university
  • Develop knowledge in assessing institutional GLP compliance
  • Develop assessment tools for measuring GLP compliance


Target Audience
QA professionals with 2 or more years of experience, testing facility management, and researchers at academic institutions interested in implementing a GLP program. Industry professionals interested in working with academic institutions. 


Agenda
  • Identify opportunities and compliance challenges
  • Defining project scope
  • Identifying stakeholders and getting buy-in
  • Creating an action plan
  • Education and promotion of the GLP program
  • Strategic planning and project management
  • Monitoring the program for success Assessing outcomes


5 — CAPA Day One: Problem Definition - Beyond Human Error (1 Day - This course is a prerequisite for CAPA Day Two)

Sunday, 26 March 2017, 8:00 a.m. - 5:00 p.m.

RQAP re-registration units: 2 GCP or GLP

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

Speakers

Eric Humes, RQAP-GLP, Medpace

Donna McElcar, MS, RQAP-GCP, ADAMAS Consulting, LLC

Judy Zahora, PMP, Biogen Idec Inc.

Prices

  • Before 27 February 2017: Student Member Rate $255, Member Rate $510, Non-member Rate $660
  • After 27 February 2017: Student Member Rate $285, Member Rate $570, Non-member Rate $720

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 advantage of a systematic methodology
  • Know what is a CAPA?
  • Define a problem (case studies to be provided for hands-on)
  • Understanding high level process mapping and the application of root cause analysis
  • Introduction to process/problem-solving tools (fishbone/is-is not/5 Whys)
  • Develop corrective action that addresses the Root Cause


Target Audience
Basic to intermediate 


Agenda
  • Process Improvement Fundamentals
  • Data Driven Decision Making
  • Data Driven Decision Making
  • Group practice and report out (data to trend)
  • Root Cause Analysis
  • Group practice and report out – scenario
  • Additional Information – Q&A


6 — Basic Training: History and Introduction of the US FDA GMPs (1 Day)

Sunday, 26 March 2017, 8:00 a.m. - 5:00 p.m.

RQAP re-registration units: 2 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.

Speakers

Rebecca Alcantara, Charles River Laboratories

Megan Callan, Charles River Laboratories

Christine Garvey, Charles River Laboratories

Eric Humes, RQAP-GLP, Medpace

Duane Miller, Charles River Laboratories


Prices

  • Before 27 February 2017: Student Member Rate $255, Member Rate $510, Non-member Rate $660
  • After 27 February 2017: Student Member Rate $285, Member Rate $570, Non-member Rate $720

Description
This is a course on the evolution of the FDA GMP regulations with regards to cGMP compliance. Included is the history of the GMP regulations, an overview of 21 CFR Parts 210 and 211 and touch on new and draft guidance documents. 

Objectives
At the end of the course, the participants shall be able to: 
  • Have an understanding of how the GMP regulations were developed.
  • Have a basic understanding of GMPs and their application based on the overview of the 21 CFR Parts 210 and 211 regulations.


Target Audience
Quality Professionals, Project Manager, Study Personnel, Validation Personnel, Facilities Personnel 


Agenda
  • History of the FDA with regards to GMPs ( from the 1820s to 1976 when the regulations were instituted). Events are outlined during the course of time, current events and events that influenced and impacted the development of the regulations
  • GMPs Worldwide - Short description of how GMPs are regulated in countries outside of the US -FDA's current thinking
  • Changes to the GMPs Review of each of the subsections in 21CFR Part 210 and 211. Organization and Personnel, Buildings and Facilities, Equipment, Controls of Components and Drug Product Container and Closure and many more!


7 — GCP Audits in Biostatistics: Enhancing Data Integrity (1 Day)

Sunday, 26 March 2017, 8:00 a.m. - 5:00 p.m.

RQAP re-registration units: 2 GCP or non-GLP

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

Speakers

Rita Hattemer-Apostel, Verdandi AG

Jonathan Wright, Numerus


Prices

  • Before 27 February 2017: Student Member Rate $255, Member Rate $510, Non-member Rate $660
  • After 27 February 2017: Student Member Rate $285, Member Rate $570, Non-member Rate $720

Description
GCP audits in biostatistics are a relatively rare occurrence, especially when compared to the vast number of investigator site audits in a clinical trial. Reasons for this include that biostatistics processes are done only once for a clinical trial regardless of the number of investigator sites included and trial subjects enrolled. Also, because of the strong focus on investigator site audits, many auditors have little opportunity and lack the experience in auditing biostatistics.The course offers a comprehensive overview on relevant biostatistics processes from the design to analysis and reporting of a clinical trial. For each biostatistics process, we'll present the applicable regulatory references, sample processes and how the process would look like if it complied with GCP. We will outline the questions QA auditors should ask and will discuss typical audit scenarios and observations that we came across in our audits. The course is designed for GCP QA auditors who are curious to gain a dependable understanding of audits in biostatistics. The course will include presentations as well as interactive sessions and short workshops. 

Objectives
At the end of the course, the participants shall be able to: 
  • Understand core procedures in biostatistics related to the conduct of clinical trials.
  • Know the GCP regulatory requirements and expected documentation for biostatistics.
  • Perform audits and identify deficiencies and weaknesses in biostatistics procedures followed in GCP trials.


Target Audience
GCP auditors with an interest in broadening their audit portfolio and wish to assess processes in biostatistics. Experience in the conduct of GCP audits is expected for this course. Biostatisticians who are interested to learn what GCP auditors are looking for are also welcome. 


Agenda
  • Introduction, GCP Requirements pertinent to Biostatistics
  • Overview on GCP Audits (preparation, conduct, follow-up)
  • Auditing Biostatistical Processes (Part I): Protocol and Amendments, Sample Size Estimation, Randomization, Data Monitoring Committee
  • Auditing Biostatistical Processes (Part II): Statistical Analysis Plan, Analysis Programming, Interim Analysis, (Blind) Data Review Meeting
  • Auditing Biostatistical Processes (Part III): Unblinding and Final Analysis, Statistical Report/Clinical Study Report, Validation of Computerized Systems
  • Questions & Answers, Wrapping Up


8 — CAPA Day Two: CAPA Creation and Effectiveness - Beyond Training (Across GxPs) (1 Day - CAPA Day One is a prerequisite for this course)

Monday, 27 March 2017, 8:00 a.m. - 5:00 p.m.

RQAP re-registration units: 2 GCP or GLP

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

Speakers

Eric Humes, RQAP-GLP, Medpace

Donna McElcar, MS, RQAP-GCP, ADAMAS Consulting, LLC
Judy Zahora, PMP, Biogen Idec Inc.


Prices

  • Before 27 February 2017: Student Member Rate $255, Member Rate $510, Non-member Rate $660
  • After 27 February 2017: Student Member Rate $285, Member Rate $570, Non-member Rate $720

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
  • Review of Problem Definition and Root Cause Analysis
  • Group Refresher Root Cause Analysis
  • The Purpose of a CAPA
  • How to Facilitate CAPA Effectiveness
  • Group Practice (CAPA Steps 5-6 )
  • Group Practice and Report
  • Fundamental Change through Trend Analysis and Process Improvement
  • CAPA Systems
  • Group Scenario – CAPA Systems and Communication
  • Q&A


9 — An Auditor's Primer on the Science, Practice, and Auditing of Chromatography and Mass Spectrometry (1 Day)

Monday, 27 March 2017, 8:00 a.m. - 5:00 p.m.

RQAP re-registration units: 2 GLP or non-GCP

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

Speakers

Steven Orr, Southern Research Institute

Deborah Parker, Bristol-Myers Squibb

Stephen Rogenthien, RQAP-GLP, Ricerca Biosciences LLC

Natasha Savoie, Algorithme Pharma Inc


Prices

  • Before 27 February 2017: Student Member Rate $255, Member Rate $510, Non-member Rate $660
  • After 27 February 2017: Student Member Rate $285, Member Rate $570, Non-member Rate $720

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 professional’s skills for auditing chromatographic and mass spectrometric data. Students 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
  • Use their newly gained understanding to better audit small molecule bioanalytical data in a GLP or GCP regulatory environment
  • Be able to provide guidance on failure investigations


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 spans from beginner to experienced quality professionals who have at minimum a basic knowledge of GLP or GCP regulations. 


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


10 — Making Social Media Work for You (1/2 Day)

Monday, 27 March 2017, 8:00 a.m. - 12:00 p.m.

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.

Speakers

Jamie Colgin, CISA, CRISC, ASQ CQA, Colgin Consulting Inc

Joseph Franchetti, JAF Consulting Inc


Prices

  • Before 27 February 2017: Member Rate $0 (This course is only for SQA Members)
  • After 27 February 2017: Member Rate $0 (This course is only for SQA Members)

Description
Join two social media pros in exploring how to get the most out of social media for your career. The course will concentrate on use of LinkedIn and Twitter. Attendees should bring their laptops and smart phones. 

Objectives
At the end of the course, the participants shall be able to: 
  • Use LinkedIn to make connections, join and contribute to groups, research jobs and companies, publish content
  • Use Twitter to follow people, tweet, reply, retweet, and quote, post pictures and links to content, use hashtags, use direct messaging


Target Audience
Any SQA member interested in learning how to use social media to grow their network, stay current on trends, and create an on-line presence. 


Agenda
  • Introduction
  • LinkedIn
  • Twitter
  • What's next?


11 — SQA Leadership Development (1/2 Day)

Monday, 27 March 2017, 1:00 - 5:00 p.m.

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.

Speakers

Catherine Bens, Colorado State University

Kimberly Frazier, MS, Kim Frazier Consulting, LLC

Elliott Graham, RQAP-GLP (Em), Society of Quality Assurance


Prices

  • Before 27 February 2017: Member Rate $0 (This course is only for SQA Members)
  • After 27 February 2017: Member Rate $0 (This course is only for SQA Members)

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)


12 — QA Consulting 101 (1/2 Day)

Thursday, 30 March 2017, 1:30 - 5:30 p.m.

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.

Speakers

Lisa Fink, Baxter Healthcare Corporation

Linda Frederick, RQAP-GLP, Janemark Corp

Robin Guy, MS, DABT, RQAP-GLP, Robin Guy Consulting, LLC

Deanna Talerico, RQAP-GLP, Charles River Laboratories


Prices

  • Before 27 February 2017: Student Member Rate $145, Member Rate $285, Non-member Rate $385
  • After 27 February 2017: Student Member Rate $175, Member Rate $345, Non-member Rate $445

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, and how to handle troublesome audits for your client. 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 necessities and niceties. This course is targeted for those QA professionals who want to learn more about consulting or have the desire to pursue consulting as a career. 

Objectives
At the end of the course, the participants shall 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.
  • Formulate ways to handle troublesome audits for your client.


Target Audience
QA professionals who want to learn more about consulting or have the desire to pursue consulting as a career 


Agenda
  • Introduction
  • Setting up and running your consulting company
  • Meeting expectations of your client (the Sponsor)
  • What the CROs expect from you as a consultant
  • Handling troublesome audits for your clients


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

Thursday, 30 March 2017, 1:30 - 5:30 p.m.

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

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

Speakers

Barb Munch, GlaxoSmithKline

Kathy Newland, Pfizer Inc


Prices

  • Before 27 February 2017: Student Member Rate $145, Member Rate $285, Non-member Rate $385
  • After 27 February 2017: Student Member Rate $175, Member Rate $345, Non-member Rate $445

Description
This training teaches the history behind the GLPs, why they were written as they were, and how to apply them in today's environment. The fraud uncovered by the FDA was astounding, and led to the creation of the GLPs. Have you heard of the magic pencil study or the swamp? Did you know that tissue masses were removed from live animals to 'take a look to see what was inside'? This presents GLP training in a novel way, by linking fraud to regulations to SOPs to the FDA Compliance Program Guidance Manual to recent 483s. 

Objectives
At the end of the course, the participants shall be able to: 
  • Learn the history behind the FDA GLP regulations
  • Learn the correlation between the initial fraud, regulations, and CPGM
  • Learn how to apply the GLPs to situations at their local labs
  • Understand how to apply history learnings to write better findings


Target Audience
Anyone interested in understanding why the FDA GLP regulations were written and how they can be applied, spans from beginner to experienced professionals. 


Agenda
  • History prior to 1970s
  • Searle Pharmaceutical, Searle Task Force
  • Industrial Bio-Test Lab
  • Monsanto
  • Hazleton Lab
  • Congressional hearing, Bressler Report
  • Regulatory action, IBT Trial
  • Practical exercises to write robust audit findings by applying history learnings to specific situations


14 — FDA Inspections: Tales from the Trails (1/2 Day)

Thursday, 30 March 2017, 1:30 - 5:30 p.m.

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.

Speakers

T.R. Papson, Regulatory Consultants Group

Fredda Shere-Valenti


Prices

  • Before 27 February 2017: Student Member Rate $145, Member Rate $285, Non-member Rate $385
  • After 27 February 2017: Student Member Rate $175, Member Rate $345, Non-member Rate $445

Description
Fredda Shere-Valenti and T.R. Papson will explain how industry can play a role in making an FDA inspection more productive for all involved. Past inspections that they conducted while working for the FDA will be shared. T.R. (FDA for 25 years) and Fredda (for almost 39 years) will discuss specific inspectional interactions and also areas of of concern from an FDA perspective.

Objectives
At the end of the course, the participants shall be able to: 
  • Describe techniques to assure a successful FDA inspection
  • Identify ways in which industry plays a role in making an FDA inspection more productive for all involved


Target Audience
Personnel involved in FDA Inspections


Agenda
  • Welcome
  • Housekeeping, Agenda Review and Introductions
  • Inside the FDA and the Late Night News
  • FDA Inspections 101: Who, What, Why , When and Where ~Inspection Readiness
  • Break
  • Walk-thru and Mock Inspections
  • QA as Personnel Partner
  • Q & A and Course Wrap Up


15 — Implementing 21 CFR Part 11 Compliant e-Signatures (1/2 Day)

Thursday, 30 March 2017, 1:30 - 5:30 p.m.

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.

Speakers

Randall Basinger, QuintilesIMS

Joseph Franchetti, JAF Consulting Inc

Joseph Whittemore, Pfizer Inc


Prices

  • Before 27 February 2017: Student Member Rate $145, Member Rate $285, Non-member Rate $385
  • After 27 February 2017: Student Member Rate $175, Member Rate $345, Non-member Rate $445

Description
By the end of this training, you will have the understanding of the differences between electronic and digital signatures and have the practical knowledge and tools for implementing a compliant e-signature system in your organization.This session will focus on how to evaluate the different solutions available, how to define the requirements of a compliant system and discuss the governance of these types of systems. 

Objectives
At the end of the course, the participants shall be able to: 
  • Understand the differences between electronic and digital signatures.
  • Evaluate different solution providers for business and technology capability.
  • Identify Risks and Requirements for the implementation of a compliant system.
  • Understand the core governance of a compliant system.


Target Audience
This training is ideal for personnel who are interested in learning about electronic and digital signatures and will be working to implement a compliant solution for their organization. The training is especially useful for Business Process Owners, Project Managers, Quality Assurance, Regulatory, Internal Audit Groups, Supplier Management, Senior Management, and staff from Information Technology and Security.


Agenda
  • Intro: What is a Digital Sig
  • What is an e-Sig
  • What are the various forms/formats of e-sigs
  • Regulations: US and ex-US- EU esig directive, Part 11, ESIGN, etc
  • How to evaluate an eSig vendor or software
  • Examples of industry leading tools
  • Considerations for Implementation
  • What are your requirements?
  • Internal vs external
  • Do you often require notary?
  • Cultural "need" for a visual of the signature
  • Integration with various systems
  • Workflow requirements/use cases
  • Specific record types only?
  • US and ex US?
  • Credentialing- internal/external
  • SAFE signatures
  • Data Privacy Considerations
  • Change Management
  • SOP revisions
  • Process changes
  • Governance
  • Who owns this tool and processes
  • Do you have corporate policy that supports e-Sig
  • Who addresses questions of policy and acceptable use


16 — GLP Metrics and You: Perfect Together (1/2 Day)

Thursday, 30 March 2017, 1:30 - 5:30 p.m.

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.

Speakers

Nancy Catricks, MS, Charles River Laboratories

Pamela Shaver-Walker, Charles River Laboratories

Matthew Vaneman, Charles River Labs


Prices

  • Before 27 February 2017: Student Member Rate $145, Member Rate $285, Non-member Rate $385
  • After 27 February 2017: Student Member Rate $175, Member Rate $345, Non-member Rate $445

Description
It’s all about the data. In a study, that data is the raw data. For Testing Facility Management in a GLP facility, that data is metrics. During this course, we will explore perspectives of QA and Testing Facility Management on value-added metrics and how to use them to make sound decisions for improving operations. 

Objectives
At the end of the course, the participants shall be able to: 
  • Identify 3 ways in which QA and Operations metrics can be utilized in a GLP laboratory.
  • List 3 types of metrics that could be implemented in a GLP laboratory.
  • Analyze the data from the metrics to make recommendations.


Target Audience
GLP Management and Testing Facility Management – target audience is for personnel responsible for managing a GLP facility. 


Agenda
  • Opening Overview of Metrics
  • TFM perspective on Metrics
  • QA Perspective on Metrics
  • Group exercise on analyzing a metrics data set


17 — No Such Thing as GxP Compliance - A Quality System Management Approach to Navigate a Complex Regulatory Environment (1 Day)

Friday, 31 March 2017, 8:00 a.m. - 5:00 p.m.

RQAP re-registration units: 2 GCP or GLP

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

Speakers

Erica Agy, Seattle Cancer Care Alliance

James Ault, RAC,RQAP-GLP, Private Consultant

Melissa Eitzen, MS,RQAP-GLP, University of Texas Medical Branch

Gregory Furrow, Southern Research Institute

Eric Humes, RQAP-GLP, Medpace


Prices

  • Before 27 February 2017: Student Member Rate $255, Member Rate $510, Non-member Rate $660
  • After 27 February 2017: Student Member Rate $285, Member Rate $570, Non-member Rate $720

Description
This course is designed to broaden/promote a better understanding of the various Title 21 regulations among QA Professionals in order to expand knowledge and improve communication among SQA members, sponsors, regulatory agencies and CROs. Course content addresses regulations from a Quality System perspective. A panel of expert speakers utilize basic elements of Quality Systems to describe GLP, GCP (human and veterinary,) and GMP regulations. Knowledge learned is applied to enhance understanding of complex areas such as GLP efficacy studies (for Animal Rule,) laboratory assays conducted under Good Clinical Laboratory Practices, 21 CFR Part 11, Good Tissue Practices (GTP< and documentation standards for product development studies. Additional course topics include an overview of the regulatory process and how to work with regulatory Affairs departments. 

Objectives
At the end of the course, the participants shall be able to: 
  • Compare and contrast Title 21 regulations using Quality System elements.
  • Recognize differences in regulatory terminology.
  • Increase professional communication skills.
  • Apply Quality System processes to reduce compliance risk.


Target Audience
This course is suitable for all QA professionals. Novice Auditors will gain knowledge of the "big picture" of the entire regulatory process while also learning important terminology. Seasoned QA professionals who specialize in one area of Title 21 regulations will gain an understanding and appreciation of differences and commonalities that are shared with colleagues working in other specialty areas. 


Agenda
  • Welcome/Introduction
  • Overview of the Regulatory Pathway
  • GLP as a Quality System
  • Applying GLP as a Quality System in Product Development Studies
  • Human GCP as a Quality System
  • Veterinary GCP as a Quality System
  • GMP as a Quality System
  • Combining Quality Systems for Animal Efficacy Studies (Animal Rule Studies)
  • Applying Quality Systems for Good Clinical Laboratory Practices
  • The Role of Part 11 in Quality Systems
  • CAPA Systems and Root Cause Analysis Across Title 21 Regulations
  • Test Your knowledge: Good Tissue Practices
  • Q & A and Panel Discussion


18 — Sponsor GCP Mock Inspections: Why, How, When, Who (1 Day)

Friday, 31 March 2017, 8:00 a.m. - 5:00 p.m.

RQAP re-registration units: 2 GCP or non-GLP

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

Speakers

Marie Falvo, CCRP, Boston Scientific

Celeste Gonzalez, RQAP-GCP, CCRP, Clinical QA International


Prices

  • Before 27 February 2017: Student Member Rate $255, Member Rate $510, Non-member Rate $660
  • After 27 February 2017: Student Member Rate $285, Member Rate $570, Non-member Rate $720

Description
This workshop will prepare GCP auditors and compliance specialists to be a part of and/or conduct mock GCP sponsor inspections. Participants will learn how: sponsor clinical regulatory inspections are conducted, the logistics of an inspection, to prepare the materials to be used in the conduct of a mock audit, to develop mock inspection plans, communicate appropriate sponsor-role audit behavior, to develop daily and end of inspection closeout reports/debriefs. 

Objectives
At the end of the course, the participants shall be able to: 
  • Identify the roles that should be part of a mock inspection, e.g. SMEs, facilitators, strategists, scribes
  • Identify and begin to develop the preparatory materials needed and the logistics involved to effectively conduct and/or be part of a mock GCP inspection
  • Communicate appropriate audit behavior for sponsor-based inspection roles
  • Develop a mock inspection plan
  • Develop daily and end of inspection closeout reports/debriefs


Target Audience
GCP auditors and compliance specialists in the pharma, medical device and biologicals sectors who have, or may have, roles in a regulatory authority GCP or BiMO inspection of a sponsor. 


Agenda
  • Introduction, Objectives, etc.
  • Typical (not for-cause) BiMo inspection overview
  • Discussion of inspection roles
  • Inspection Behaviors - The Good, The Bad, The Ugly
  • Preparation of Subject Matter Experts
  • Selection and preparation of materials and the logistics for conduct of a ock inspection. Includes SME storyboards preparation instruction, templates, etc.
  • Development of daily and end of mock inspection reports/debriefs
  • Preparing a Lessons Learned storyboard


19 — GCP: Beyond the Basics (1 Day)

Friday, 31 March 2017, 8:00 a.m. - 5:00 p.m.

RQAP re-registration units: 2 GCP or non-GLP

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


Speakers

Christopher Both, RQAP-GCP, Life Science Compliance LLC

Jamie Colgin, CISA, CRISC, ASQ CQA, Colgin Consulting Inc

Glenda Guest, RQAP-GCP, Norwich Clinical Research Associates Ltd

Jean Mulinde, US Food and Drug Administration

Lee Truax-Bellows, RQAP-GCP, NCRA

Prices

  • Before 27 February 2017: Student Member Rate $255, Member Rate $510, Non-member Rate $660
  • After 27 February 2017: Student Member Rate $285, Member Rate $570, Non-member Rate $720

Description
This interactive session will provide experienced GCP QA professionals with additional 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. In addition to these topics, this session will also provide the regulatory perspective as it relates to the current status of GCPs as experienced in the global community. 

Objectives
At the end of the course, the participants shall be able to: 
  • The attendee shall be able to incorporate presented regulatory updates as part of their auditing activities
  • The attendee shall be able to define a quality management system
  • The attendee shall be able to differentiate between ICH and ISO GCP requirements


Target Audience
GCP professionals with 2 years experience from both the Sponsor and Site level within industry (pharma, biologics and device) and investigative sites. 


Agenda
  • Applying a Quality Management System (QMS) Approach to GCPs
  • Additional skills auditors will need to conduct auditing under a QMS approach
  • US & EU Regulatory Updates
  • ICH E6 R2 Update
  • Comparing ICH E6 R2 to ISO 14155
  • FDA’s Approach to Quality Management System in GCPs
  • Q&A


20 — Next Generation QA (1 Day)

Friday, 31 March 2017, 8:00 a.m. - 5:00 p.m.

RQAP re-registration units: 2 GCP or GLP

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


Speakers

Rita Hattemer-Apostel, Verdandi AG

Anthony Jones, inVentiv Health Clinical

Prices

  • Before 27 February 2017: Student Member Rate $255, Member Rate $510, Non-member Rate $660
  • After 27 February 2017: Student Member Rate $285, Member Rate $570, Non-member Rate $720

Description
The course provides an opportunity for the QA auditor to learn about systems thinking, system dynamics and related areas and how that knowledge may enrich quality management and lead to a deeper understanding of the nature of QA. 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. 

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 assurance
  • 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 QA, in particular systems thinking tools and techniques, enhance professional and personal growth and their contribution towards a quality organization. 


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


21 — Data Quality/Data Integrity: Can You Trust the State of Your Data? (1 Day)

Friday, 31 March 2017, 8:00 a.m. - 5:00 p.m.

RQAP re-registration units: 2 GCP or GLP

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


Speakers

Catherine Bens, Colorado State University

Joseph Franchetti, JAF Consulting Inc


Prices

  • Before 27 February 2017: Student Member Rate $255, Member Rate $510, Non-member Rate $660
  • After 27 February 2017: Student Member Rate $285, Member Rate $570, Non-member Rate $720

Description
Data Quality and Data Integrity are key components in measuring the reliability, accuracy and confidence in data. This introductory course will provide an overview of the terminology used to define Data Quality and Data Integrity concepts. Evaluation tools and techniques will be presented along with a discussion on the impact of poor Data Quality and Data Integrity and federal guidance. 

Objectives
At the end of the course, the participants shall be able to: 
  • Define the terms Data Quality/Data Integrity
  • Identify what can impact Data Quality/Data Integrity
  • Describe methods and tools for evaluating Data Quality/Data Integrity
  • Discuss the consequences of poor Data Quality/Data Integrity


Target Audience
Research and GXP professionals with an interest in broadening their perspective on Data Quality/Data Integrity concepts. 


Agenda
  • Data Quality/Data Integrity Lexicon Concepts to Consider: Stakeholders; Importance of Quality of Source Data; Federal guidance; Defining the audit trail and data governance in maintaining data integrity; Hard Copy vs. Electronic Data; Using Trends and Tools for assessing data quality and integrity; Impact of using Cloud Computing Infrastructure; COTS/Internally Developed Software; Open Source Tools/Data; Electronic data issues
  • How to assess Data Quality/Data Integrity during an audit Cost of Poor Data Quality/Data Integrity


22 — Archiving 101: What You Need to Know About a GLP-Compliant Archive (1/2 Day)

Friday, 31 March 2017, 8:00 a.m. - 12:00 p.m.

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

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

Speakers

Brooke Coblentz, Charles River Laboratories

Arif Demirel, BS, Charles River Laboratories

Renee Nussbaumer, Johnson & Johnson


Prices

 

  • Before 27 February 2017: Student Member Rate $145, Member Rate $285, Non-member Rate $345
  • After 27 February 2017: Student Member Rate $175, Member Rate $385, Non-member Rate $445

Description
Archiving has gained attention recently as more diverse data types are being generated by scientists and more 483's are issued by the agency. This course answers the who, what, when, where, why and how of archiving including auditing of an archive. 

Objectives
At the end of the course, the participants shall be able to: 
  • List the items that need to be archived for a study;
  • Audit an archive for GLP compliance;
  • Outline a plan for establishing a GLP archive;
  • Get a basic understanding of electronic archiving.


Target Audience
This course will be aimed at new GLP auditors or those responsible for establishing and / or maintaining a GLP archive. 


Agenda
  • Welcome and Introductions
  • The Who, What, When, Where, Why, and How of GLP Archiving
  • Auditing of the Archive
  • Introduction to Electronic Archiving


23 — Archiving 201: Beyond a GLP-Compliant Archive (1/2 Day)

Friday, 31 March 2017, 1:00 - 5:00 p.m.

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

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


Speakers

Eric Bovard, Janssen R&D

Arif Demirel, BS, Charles River Laboratories

Kathy Newland, Pfizer Inc

Thomas Purdue, RQAP-GLP, Boehringer Ingelheim Pharmaceuticals, Inc


Prices

 

  • Before 27 February 2017: Student Member Rate $145, Member Rate $285, Non-member Rate $385
  • After 27 February 2017: Student Member Rate $175, Member Rate $345, Non-member Rate $445

Description
This course is intended to complement the Archiving 101 training by providing in depth review of archiving requirements across multiple regulations, describing records management at a corporate level, detailing what to do in the event you need to transfer/move an archive and address some of the issues created by acquisitions and divestitures. We will also cover some advanced concepts of archiving electronic records. 

Objectives
At the end of the course, the participants shall be able to: 
  • Describe the regulatory landscape for archiving;
  • Identify the component needed to implement a records management program;
  • Plan and execute the transfer of archived materials;
  • Understand the complexity of archiving electronic records.


Target Audience
This course is aimed at experience GxP auditors or those responsible fro operating a regulated archive or involved in records management. 


Agenda
  • Welcome and Agenda
  • Regulatory Landscape for archiving across GxPs
  • Records Management - A Corporate Approach
  • My Archive is Moving - What Should I Do and What Should I Expect?
  • Advanced Topics for Electronic Archiving