April 2016 Quality College Course Descriptions




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

8:00 AM 3 April 2016 – 5:00 PM 4 April 2016

RQAP re-registration units: 4.00 GLP or non-GCP

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

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 is a basic GLP course that will provide the participant with a valuable learning experience. This course focuses on the GLP regulations, how to apply them, and who is responsible for ensuring the uniformity, consistency, reliability, reproducibility, quality, and integrity of nonclinical laboratory studies. This training will utilize real-life scenarios in practical exercises to assist in the learning process and will also provide valuable resources to reference in the future. This Basic Good Laboratory Practice training course is designed for anyone needing to learn about GLP regulations; including, but not limited to: QA Personnel (GLP Auditors), Study Directors, Principal Investigators, Management, Scientists, Technicians, Facilities Personnel, and Archivists, with 0-2 years or more of experience. 


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

* Practical Exercises will be interspersed in-between presentations


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

8:00 AM 3 April 2016 - 5:00 PM 4 April 2016

RQAP re-registration units: 4.00 GCP or non-GLP

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

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 done during a GCP 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
  • History and Principles of GCP
  • 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


3 — Basic Concepts in Computer Validation (2 Days)

8:00 AM 3 April 2016 - 5:00 PM 4 April 2016

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.

Description
The purpose of this 2-day introductory workshop training session is to provide the QA Professional with an overview of the validation process, regulatory expectations and auditing strategies base on Industry standards and guidance. It also will provide the Course attendees the “how to get it done” by participating in break-out sessions and exercises to enhance their level of understanding the concepts presented. The concepts presented will be based on the industry leading document from the Drug Information Association, Computerized Systems Used in NonClinical Safety Assessment: Current Concepts in Validation and Compliance. This guideline explores the current regulatory environment and new challenges in the development, validation, and use of computerized systems in nonclinical laboratories and describes the best practices to ensure their quality at that time. 

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

 

  • The course is designed to provide a thorough understanding of computer system validation by providing a framework on how to execute the System Life Cycle.
  • The course will address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process.
  • The attendee will 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 Deliverables.
  • Planning, Conducting and Documenting the Computer Validation Audit.


4 — CAPA Day One: Problem Definition - Beyond Human Error (1 Day)

8:00 AM - 5:00 PM 3 April 2016

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.

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)


Target Audience
Basic to intermediate. 


Agenda
  • Process Improvement Fundamentals
  • 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


5 — GLP Beyond the Basics (1 Day)

8:00 AM - 5:00 PM 3 April 2016

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.

Description
The GLP Beyond the Basics course is designed to take your application of the GLP regulations to the next level. Learn what types of data you and your management can review to ensure value added auditing and appropriate risk management. Spend the afternoon with us taking a deep dive into the GLP preambles to understand how and where it all began. 

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

 

  • Understand types of metrics that can be utilized in a GLP facility
  • Have a working knowledge of quality risk management and how to apply it to auditing practices
  • Utilize the preambles to understand the GLP regulations


Target Audience
GLP auditors with three or more years experience. 


Agenda
  • Quality Risk Management and Metrics
  • GLP Preambles


6 — CAPA Day Two: Creation and Effectiveness - Beyond Training (Across GxPs) (1 Day)

8:00 AM - 5:00 PM 4 April 2016

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.

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


7 — Next Generation QA (1 Day)

8:00 AM - 5:00 PM 4 April 2016

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.

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
  • Broadening the Perspective: Systems Thinking and More
  • Putting the New Tools and Ideas to Use
  • Engaging to Add Value


8 — Basic GCP for Veterinary Studies (1/2 Day)

8:00 AM - 12:00 PM 4 April 2016

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.

Description
The Animal Health Specialty Section (AHSS) of SQA is sponsoring a Basic Veterinary Good Clinical Practice (GCP) training course for all interested animal health professionals. As the title of the course implies, this session is designed as an introductory or refresher course that will cover the basic elements of 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. The course will be team-taught and will include representation from various companies and possibly one or more regulators. 

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

 

  • To review & discuss the roles of the clinical investigator, monitor, and sponsor
  • To provide an overview of documentation types and requirements
  • To engage participants with brief scenarios of key points
  • To discuss the implicit role of quality assurance


Target Audience
Animal Health Professionals (Clinical Investigators, Quality Assurance, Sponsors, Monitors) wanting an overview of the basics of veterinary Good Clinical Practice. 


Agenda
  • Overview to VICH and GCPs
  • Clinical Investigator Responsibilities
  • Source Data and Documentation
  • The Role of the Monitor
  • Sponsor Responsibilities
  • Quality Assurance’s ‘Implied’ Role
  • Scenarios


9 — Archiving 101 (1/2 Day)

8:00 AM - 12:00 PM 4 April 2016

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.

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, & how of archiving and associated processes, including auditing 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 compliant archive
  • Get a basic understanding of archiving electronic records


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


Agenda
  • Welcome & Introductions
  • The Who, What, When, Where, Why, & How of GLP Archiving
  • The Archive – more than just a place to “store my stuff”
  • Auditing the Archive
  • The basics of archiving electronic records


10 — Data Quality/Data Integrity (1/2 Day)

8:00 AM - 12:00 PM 4 April 2016

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.

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

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 for evaluating Data Quality/Data Integrity
  • Discuss the consequences of poor Data Quality/Data Integrity


Target Audience
GxP professionals with an interesting in broadening their perspective on Data Quality/Data Integrity concepts.
The training is especially useful for Business Continuity and Disaster Recovery Planners, Business Unit Managers, Project Managers, Quality Assurance, Senior Management, and staff from Information Technology, Security, Emergency Response and Crisis Management, Communications, Facilities, Operations Management and Human Resource Departments. 


Agenda
  • Data Quality/Data Integrity Lexicon
  • Concepts to Consider: Stakeholders, Importance of Quality of Source Data, Hard Copy vs. Electronic Data, Using Trends, Impact of using Cloud Computing Infrastructure, COTS/Internally Developed Software, Open Source Tools/Data
  • How to assess Data Quality/Data Integrity during an audit
  • Cost of Poor Data Quality/Data Integrity


11 — SQA Leadership (1/2 Day)

1:00 - 5:00 PM 4 April 2016

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.

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. 



12 — Archiving 201 (1/2 Day)

1:00 PM - 5:00 PM 4 April 2016

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.

Description
This course is intended to complement the Archiving 101 training by providing in depth review of archiving requirements across multiple regulations, describing what records management means at a corporate level, detailing what to do in case archived records needs to be moved and addressing some of the issues created by acquisitions and divestitures. We will also cover some advanced concepts of archiving electronic records, such as scan and destroy, transferring from paper to electronic.... 

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 a transfer of archived materials
  • Understand the complexity of archiving electronic records


Target Audience
This course would be aimed at experienced GxP auditors or those responsible for establishing and/or operating a regulated archive or involved in records management. 


Agenda
  • Welcome & Introductions
  • Regulatory landscape for archiving across GXPs
  • Records Management - a corporate approach
  • My archive is moving - What should I do and expect
  • Advanced topics for Archiving electronic records


13 — GCP Data Stewardship (1/2 Day)

1:00 PM - 5:00 PM 4 April 2016

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.

Description
Even established GCP professionals can feel at a disadvantage when facing the regulatory challenges that arise with new digital technologies and electronic data. Data Stewardship is an approach that allows established GCP principles to be applied with confidence in the fast changing world of tablet devices, evolving EDC systems, and eSource. The course particularly highlights managing the challenges posed by the digital environment in dispersing data and responsibility across multiple entities, many of whom are not traditionally regulated. Master the application of GCP-ICH in the operational world of computerized systems used in the conduct of clinical trials--knowing what to do after the validation has been signed. While the course focuses heavily on application in the GCP environment, most elements can also be applicable to GLP and GMP environments. 

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

 

  • Identify and apply 5 key established GCP-ICH Good Documentation practices to address issues in the digital data environment.
  • Analyze the application of GCP-ICH "Predicate Rules" to key digital technologies and "eSource" data.
  • Create a comprehensive data integrity road map identifying "data steward" entities and their associated areas of stewardship across a Clinical Trial data flow.
  • Defend Good Documentation Practices for electronic data during health authority inspections.


Target Audience
QA professionals who oversee general GCP-ICH compliance for clinical trials; QA professionals who prepare and support clinical trial teams for health authority inspections; QA professionals in "eCompliance" roles. (e.g., computerized system validation, 21 CFR Part 11, etc.) 


Agenda
  • Challenges posed to "traditional" GCP QA by the rapidly evolving world of digital devices and eSource in clinical trials.
  • After the Validation Report is Signed: There's more to IT than IT
  • Beyond 21 CFR Part 11: Using Good Documentation Practices to Cross the IT Boundary--
  • How the "paper as Gold Standard" metaphor fails us and how we can move beyond it.
  • Defining and applying "Data Stewardship" in the GCP context.
  • Identifying & mapping "Data Stewards" and their stewardship domains across a clinical trial.
  • Defining and using stewardship domains across multiple entities to achieve clarity and consistent compliance.
  • Demystifying devices, data flows, and data integrity across multiple participating entities (e.g., vendors, IT support, infrastructure support, etc.).
  • Facing the inspectors--marshaling data stewards for proactive data integrity defense


14 — QA Consulting (1/2 Day)

1:00 - 5:00 PM 7 April 2016

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.

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 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 desire to pursue consulting as a career.


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


15 — Fraud and Misconduct in PV and GMP (1/2 Day)

1:00 - 5:00 PM 7 April 2016

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.

Description
This course will discuss the following: No reporting of the serious ADRs for more than 10,000 cases were found at Novartis Japan. Regulatory inspections now conducted by prefectural government did not help for preventing this misconduct. “Self Inspections” which has been required and encouraged by J-GVP law also did not work.; Rambaxy india's GMP quality test was of fraud and FDA inspection noticed eight serious misconducts. Ethical and cultural prejudice is underlying for this fraud.; For preventing the non-compliance, frauds and misconducts, global and powerful audits is the key for the preventive action and importance of quality assurance action is strongly proposed. 

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

 

  • Understand Novartis Japan's PV incompliance
  • Understand Rambaxy India's GMP Fraud
  • Recognize what caused for these examples of misconduct and fraud
  • Understand the importance of (global) quality assurance
  • Understand how the management can prevent fraud and misconduct within their company


Target Audience
PV auditors and GMP auditors with three or more years experience; Corporate top managers who want to prevent company fraud and misconduct


Agenda
  • Introduction
  • Incidents and Information
  • Analysis
  • Company's Immediate Action
  • Regulatory Action
  • Preventive Action and Solutions
  • What Should QA Do?


16 — History of the FDA GLPs (1/2 Day)

1:00 - 5:00 PM 7 April 2016

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.

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


17 — E2E Electronic Laboratory (1/2 Day)

1:00 - 5:00 PM 7 April 2016

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.

Description
Have you ever wondered what it takes to make your laboratory fully electronic? How can you develop and execute a compliant system for data capture and reporting that can be shared with external auditors and health authorities? This course will address all the steps necessary to design, test, and execute a fully electronic laboratory. 

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

 

  • List the criteria needed for effective, compliant electronic data capture.
  • Identify archival and retrieval strategies and storage.
  • Understand the single most important criteria for automated data transfer between systems.
  • Identify the 5 most important design elements of an E2E electronic laboratory.


Target Audience
Target audience will include all QA professionals with a role in executing or auditing data within the Bioanalytical arena including computerized system validation, instrument validation (IQ, OQ, PQ), data capture, data reporting, and inspection by health authorities.


Agenda
  • Intro to Part 11 compliance and data capture requirements of GLP and OECD
  • Taking stock of what you have
  • System Design
  • System Validation
  • System Rollout and Training
  • Data Archival and Retrieval
  • System Use for external Groups


18 — GCP Beyond the Basics (1 Day)

8:00 AM - 5:00 PM 8 April 2016

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.

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: 

 

  • Describe how GCP QA interacts with a Quality System Approach
  • Incorporate presented audit and training techniques into their roles
  • Incorporate current Regulations that impact GCP into their roles
  • Discuss how to set-up a GCP QA Program


Target Audience
GCP Professionals with two or more years of experience.


Agenda
  • Applying a Quality System Approach to GCPs
  • Setting up a GCP QA Program
  • Regulatory Updates


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

8:00 AM - 5:00 PM 8 April 2016

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.

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, and documentation standards for product development studies. Additional course topics include an overview of the regulatory pathway, the role of Regulatory Affairs, and the applicability of corrective and preventive actions (CAPA). Attendees will test their knowledge by participating in case study discussions. A Question and Answer Panel session is included to promote open discussions with attendees.

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 regulation 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 regulated 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 to 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 & Root Cause Analysis Across title 21 Regulations
  • Q & A and Panel Discussion


20 — Auditing Software and Data Providers with a Focus on Cloud Services (1 Day)

8:00 AM - 5:00 PM 8 April 2016

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.

Description
By the end of this training, you will have the essential and practical knowledge and tools for auditing software and data providers. This session will focus on computerized systems that not only reside locally, but also in the cloud. The session teaches you how to develop audit plans, and focus on the goals of the audit to guide you and your team in the execution of the audit strategy. Additionally, with the advent and increased use of hosted services (e.g., Cloud Computing), this training will explain the overuse of the term “Cloud Computing” and the similarities and differences in auditing Contract Data Center/Host Service sites.

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

 

  • Establish Vendor Audit strategy for Computing Technology Providers.
  • Develop the purpose and goals of a Software or Data Supplier Audit.
  • Organize an Audit team for a Software or Data Provider Audit.
  • Assess business and technology capability for a Supplier.
  • Evaluate business and technology risks to your organization.
  • Organize and execute an effective Audit for a computerized system, software or data or cloud provider.
  • Examine suggested approaches for conducting and reporting vendor audits.


Target Audience
This training is ideal for personnel who are new to auditing Software and Data providers but are experienced in auditing. The training is especially useful for Computer Systems Business Process Owners, Project Managers, Quality Assurance, Internal Audit Groups, Supplier Management, Senior Management, and staff from Information Technology and Security.


Agenda
  • Audit Preparation
  • Audit Execution
  • Audit in absence of Standards and Procedures
  • Audit Report & Follow-up


21 — Study Director Training (1 Day)

8:00 AM - 5:00 PM 8 April 2016

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.

Description
This course provides a thorough overview of the regulatory requirements for study oversight and direction and the roles and responsibilities of GLP Study Directors and Principal Investigators. 

Objectives
At the end of the course, the participants shall be able to: 
  • Provide background on why GLPs exist
  • Be familiar with regulations/standards
  • Understand GLP requirements
  • Have respect for importance of GLP principles
  • Provide sources of information/resources
  • Have knowledge applicable to job function
     

Target Audience
Individuals who are new to, or in training for, the role of Study Director or Principal Investigator or those who are seeking a comprehensive refresher of what it means to be the single point of GLP study control and study/study phase direction. 

Agenda
  • BRIEF HISTORY OF GLP REGULATIONS 
  • GLP REGS & STANDARDS (SIMILARITIES AND DIFFERENCES)
    FDA/EPA/OCED 
    Key Terms and Definitions
  • STUDY DIRECTOR AND PRINCIPAL INVESTIGATOR ROLES & GLP RESPONSIBILITIES
    GLP Personnel responsibilities
    Study Director/PI
    Single Point of Control/Delegation 
    TFM/TSM responsibilities delegated to SD
    SD/PI and QA interaction
    Study preparation, SD/PI involvement, Study close out
  • MULTI-SITE STUDIES
    Sponsors, SD, PI, QA
    Test Facility/Test Sites
    SD oversight and responsibilities
    Communication and reports
  • TYPES OF STUDIES, FACILITIES AND ANIMAL/TEST SYSTEM CARE
    GLP Requirements
    Study Director Responsibilities
    Study types
  • EQUIPMENT
    GLP Equipment (includes computerized systems)
    GLP Requirements
    Study Director Responsibilities
  • TEST MATERIALS
    FDA/EPA/OECD terminology and definitions
    Bulk and Mixtures
    Characterization & Stability
    Dose Formulation/Dose Analysis
  • STUDY PROTOCOL/ PLAN, CONDUCT AND STUDY REPORTS 
    GLPs requirements 
    Study Phase Reports (PI/Contributing scientist reports)
    Study results interpretation
    Archival and Record Retention
  • DATA & DOCUMENTATION
    Recordkeeping requirements
    Good Documentation practices
    Manually-recorded and computer-generated records
  • AUDITS & INSPECTIONS
    Study Director responsibilities
    Study Audits
    Agency Audits/483s
  • COMPLIANCE & QUALITY
    Reconstructibility
    Compliance Statement
    Noncompliance
    Risk to public health & safety