1 — GCLP 101: An Introduction to GCLP

Wednesday, 23 September 2020, 9:00 AM - 6:00 PM

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

Registration Fees
SQA Member: $395     Student: $195     Non-member: $515

Description
An Introduction to Good Clinical Laboratory Practices (GCLPs) and navigating the complex landscape from a quality and business perspective. Topics will include the major guidance documents accreditations, regulations and other documents used within GCLP laboratories to guide the compliance, define elements of GCLP risk-based audit program, overview of the implementation and maintenance of GCLP guidelines from a laboratory management and operations perspective and the merits and demerits of current regulatory loophole and FDA’s effort at addressing the public health concern.
 

Clinical laboratories in the US, where assays are developed and used for research purposes only (RUO) do not always follow or subscribe to CLIA regulations and existing GCLP guidelines. The objective of this course is to help the learner understand the nature of such research where results from testing clinical samples often end up in regulatory submissions. This course should give the learner an idea of what exists in the current regulatory landscape to support such testing. The course will also touch upon special cases where these regulations do not apply, and, in such cases, how to ensure that the data from such laboratories are submission-ready.

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

• Review and discuss the major guidance documents accreditations, regulations and other documents used within GCLP laboratories to guide the compliance, including Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs,) Part 11, European Medicines Agency (EMA) GCLP, CLIA, Division of Aids (DAIDS), Research Quality Association RQA, CAP and World Health Organization (WHO).
• Define elements of a GCLP risk-based audit program from a sponsor's perspective, development of an annual audit plan, preparation of a GCLP Audit scope and agenda for internal/external audits and preparation and what to expect from an audit/certification/regulatory inspection.
• Describe the implementation and maintenance of GCLP guidelines from a laboratory management and operations perspective. From a practical application standpoint, an overview of what a GCLP laboratory looks and functions like and summarize key topics that must be mplemented in a GCLP laboratory.

Target Audience
Anyone interested in GCLPs

Agenda

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

RQAP Re-registration Units:  8 non-GCP, non-GLP
 

2 — GLP 104: Auditing Techniques

Wednesday, 23 September 2020, 9:00 AM - 6:00 PM

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

Registration Fees
SQA Member: $395     Student: $195     Non-member: $515

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

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

• Summarize the regulatory requirements for GLP QA
• Describe the regulatory inspection process for nonclinical laboratory facilities, including a review of the Bioresearch Monitoring Program (BIMO) Compliance Program Guidance Manual (CPGM)
• Effectively communicate FDA GLP requirements to management and study personnel
• Audit laboratory records, electronic data and final reports for compliance with regulations
• Identify compliance gaps and effectively communicate gaps and recommendations for correction via an audit report
• Use knowledge and skills obtained through collaborative group exercises to enhance technical proficiency 

Target Audience
This course is a comprehensive introduction or refresher training for all personnel working within an FDA Good Laboratory Practice facility.

Agenda

1. Course Overview
2. Quality Assurance Responsibilities
3. CPGM Overview
4. Protocol Audits
5. Process and Phase Inspections
6. Facility Records
7. Remote Auditing
8. Electronic Records
9. Study Data (including electronic data, and audit trails)
10. Report Audit
11. Writing and Resolving Audit Reports
12. Quality Assurance Statements
13. Conducting Internal Facility and External Vendor Audits
14. Hosting Sponsor/Regulatory Audits

RQAP Re-registration Units:  8 GLP, non-GCP
 

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

Wednesday, 23 September 2020, 9:00 AM - 1:00 PM
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Registration Fees
SQA Member: $225     Student: $105     Non-member: $305

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:

• Explain the history behind the FDA GLP regulations
• Describe the correlation between the initial fraud, regulations, and Guidance Manual
• Apply the GLPs to situations at their local labs
• Apply history learnings to write better findings

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

Agenda

1. History prior to 1970s
2. Searle Pharmaceutical, Searle Task Force
3. Industrial Bio-Test Lab
4. Monsanto
5. Hazleton Lab
6. Congressional hearing, Bressler Report
7. Regulatory action, IBT Trial
8. Practical exercises to write robust audit findings by applying history learnings to specific situations 

RQAP Re-registration Units:  4 GLP, non-GCP
 

4 — DEV 201: The Ventilator Diaries: Vendor Qualification and Management for Medical Device Imports during COVID-19

Wednesday, 23 September 2020, 2:00 PM - 6:00 PM

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

Registration Fees
SQA Member: $225     Student: $105     Non-member: $305

Description

This is the story of a ventilator that was used as proof of concept for supply chain discovery by a new US importer, Touchstone Technologies, Inc. The ventilator supplier is in Asia and was shipped to the US but ultimately rejected by US customs. The ventilator was then shipped to and accepted in Germany. Unfortunately, once in Germany, the customer seems to have absconded with the ventilator, and no payment was ever received. The matter is now being pursued by legal authorities in the appropriate countries.

In this session,  Dan Solis, FDA Assistant Commissioner for Division of West Coast Imports, Dr. Suzanne Schwartz, FDA Director, Office of Strategic Partnerships & Technology Innovation at CDRH will present their perspectives and guidance on medical device supply chain and Covid-19 medical device imports. Mr. Ken Behr, an international trade attorney and former CPB Officer  will discuss the customs requirements both domestically and internationally & US tariff requirements. Ms. Angela Bazigos CEO of Touchstone Technologies, Inc., will discuss the steps and missteps that may have led to the rejection of the ventilator at US, and risk assessment and mitigation measures that were set up to manage the vendor and carrier and to protect the company in this new venture.

Target Audience

Medical Device Importers / Exporters, Commercialization Personnel, Lawyers, and anyone dealing with US and International Customs or Law Enforcement, Quality Personnel, Regulatory Affairs Personnel, Regulators

Objectives

1. Practical guidance to navigate legal and regulatory hurdles for medical device imports for Covid-19 patients during the pandemic
2. Practical guidance on US Customs requirements and additional challenges e.g. Tariffs
3. How to protect your company from domestic and international criminals during Covid-19
4. Customer Qualification as well as Vendor Qualification
5. How to recover from criminal activity should anything happen
6. How to successfully import medical devices into the US or internationally during Covid-19
   
   

Agenda

1. Introduction
2. FDA’s ORA Office of Enforcement and Import Operations
3. FDA work with CBP and Criminal Investigations
4. FDA’s Office of Strategic Partnerships and Technology Innovation at CDRH, and their EUA activities
5. Importing medical devices e.g. PPE for Covid-19
6. Going beyond normal supplier audit to ensure legitimate partners and customers
7. Yes, the carrier matters!
8. Risk mitigation strategies including:
1. Supplier audit and vetting
2. Customer vetting!!!
3. Working with Law Enforcement Agencies Across the Globe!
9. FDA Critique on import and how to successfully import medical devices for Covid-19

RQAP Re-registration Units:  4 non-GCP, non-GLP

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

Thursday, 24 September 2020, 9:00 AM - 6:00 PM

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

Registration Fees
SQA Member: $395     Student: $195     Non-member: $515

Description
This course provides a history of the GMP regulations, what is the purpose, why were they created, how did they develop over time and an overview of the sections of the regulations.

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

• Explain the purpose of the GMP regulations
• Describe how the regulations developed over time
• Provide an overview of the regulations
  
   

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

Agenda

1. History and Introduction of the US FDA GMPs
2. Overview of 21 CFR Parts 210 and 211
3. Quality Systems Overview
4. SOPs
5. Out of Specification
6. Are You Ready
7. GLP QA vs. GMP QA 

RQAP Re-registration Units:  8 non-GCP, non-GLP
 

6 — CSV 102: Auditing Agile Methodology in the Real World

Thursday, 24 September 2020, 2:00 PM - 6:00 PM

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

Registration Fees
SQA Member: $225     Student: $105     Non-member: $305

Description
Agile Manifesto was published online in 2001 and many Quality Assurance Professionals may not be aware of the simplicity of the system development lifecycle. In this session you will learn the basics of the Agile Methodology and the 12 Principles. Next, we will fast forward you to today and how the Agile Methodology is adapted by software vendors to manage their development, release strategy, and client services. The second part of the training will be how to prepare for an audit the agile environment, what software tools vendors use, and end with the conduct and reporting of the audit.

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

• Summarize the Agile Manifesto
• Explain the12 Principles of Agile Methodology
• List some Agile Software Tools
• Audit Agile Software Vendors
  
   

Target Audience
Anyone wishing to learn more about Agile Methodology

Agenda

1. Introduction
2. Agile Manifesto and 12 Principles
3. Agile Today
4. Audit preparation, conduct, debrief

RQAP Re-registration Units:  4 GCP, GLP
 

7 — GEN 107: New Skills for Quality Assurance Professionals

Thursday, 24 September 2020, 9:00 AM - 1:00 PM

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

Registration Fees
SQA Member: $225     Student: $105     Non-member: $305

Description
The future is arriving faster than we think! Automation, AI and algorithms are here, and Quality Assurance should evolve and adapt to continue to add value in our ever-changing environment. This course is an interactive reflection on the skills that QA will need to thrive, both now and over the coming decades.

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

• Summarize material describing future scenarios for business in general, and for the role of quality professionals;
• Use this material to define a set of competencies and skills that will be increasingly sought after in the future;
• Describe, with examples, how these skills can add value to the QA role; and
• Identify some of the technology that is available to support evolving roles and competencies.
  
   

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

Agenda

1. The future: insights from recent surveys and articles. The future of quality and quality assurance, Quality 4.0.
2. A framework for development: which skills will add most value now and in the future?
   • Systems: systems thinking, QMS 3.0, new scientific paradigms
   • Data: transforming data into information, knowledge and insight.
   • Models/Tools: useful models and tools to develop and support new skills
3. Effectiveness and Efficiency: creating the space to change and develop.

RQAP Re-registration Units:  4 non-GCP, non-GLP
 

8 —GLP 103: Basic GLP Archiving - What you need to know about GLP-compliant archives

Friday, 25 September 2020, 9:00 AM - 1:00 PM

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

Registration Fees
SQA Member: $225     Student: $105     Non-member: $305

Description
This course answers the who, what, when, where, why, & how of archiving (both physical and electronic) and associated processes.

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

• Summarize the basics of GLP Archiving
• Describe electronic record archiving
  
   

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

RQAP Re-registration Units:  4 GLP, non-GCP
 

9 —GLP 203: Intermediate GLP Archiving- Beyond a GLP-compliant archiving function

Friday, 25 September 2020, 2:00 PM - 6:00 PM

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

Registration Fees
SQA Member: $225     Student: $105     Non-member: $305

Description
This course will dive more into the current and future state of electronic data archiving, records management and shipping/disposing regulated materials.  

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

• Demonstrate advanced understanding of electronic systems and e-data archiving
• Describe the current and anticipated future state of Archiving
• Explain Records Management and Archiving

Target Audience
Intermediate to advanced level individuals responsible for GLP archiving.

Agenda

1. Archiving electronic records
2. Moving an archive (shipment and disposal of regulated records);
3. Records management
4. Regulatory landscape

RQAP Re-registration Units:  4 GLP, non-GCP
 

 

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

Friday, 25 September 2020, 9:00 AM - 1:00 PM

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

Registration Fees
SQA Member: $225     Student: $105     Non-member: $305

Description
Electronic records in the GxP woods are “lovely, dark, and deep”, but impossible to navigate if you don’t have an audit trail. To assure data integrity, individuals involved in a process, as well as Quality Assurance Auditors, need to review audit trails. How are audit trails reviewed when filtering is difficult? Do study monitors routinely review audit trails? Does the QAU address their audit trail practices in an SOP (as per OECD guidance)? When is audit trail review useful or necessary? This training has been developed following a 2019 SQA Annual Meeting roundtable session. We will begin with an overview of the regulations covering audit trails and points made by regulators concerning audit trails and data integrity. This will be followed by more in-depth discussions covering many questions with which auditors struggle, including the difference between system logs and audit trails and how both are useful in study based audits and data integrity audits.

The CVIC Data Integrity and Governance group has compiled several audit trail examples to use during discussions of scenarios. The examples, both real and fictitious, come from a variety of systems used in GLP, GMP, and GCP regulated industries. Individuals attending the training will leave with a greater understanding of points to consider concerning audit trails and more confidence in how to find compliance and data integrity problems when viewing audit trails.


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

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

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

 Agenda

1. 10min - Introductions and Course Overview
2. 40min plus 5 min Q&A - Data Integrity and Regulatory Requirements Overview
3. 10min - Paper Records Compared to their Electronic Audit Trail Equivalent
4. 20min plus 5 min Q&A - Managing the Audit Trail Review Process (Topics covered include: who reviews them, where is this process defined, where do the audit trails go, how to manage extensive audit trails)
5. 20min plus 5 min Q&A - System Logs vs. Audit Trails
6. 20min - Group work • Review of example audit trails and discussion
7. 15min - BREAK
8. 25min - Group Work • Review of example audit trails and discussions (continued)
9. 30min plus 5 min Q&A - Audit Trails in Action (Topics include: audit trail use as a monitoring tool for data integrity and audit trails for analyzed data)
10. 20min - Individual Work • Mock inspection and report on examples provided using electronic audit trails
11. 30min - Discuss specific issues and questions submitted at the time of registration/Open Discussion

RQAP Re-registration Units:  4 GCP, GLP
 

11 — GMP 201: Foundations for GMP Quality and Compliance

Friday, 25 September 2020, 9:00 AM - 6:00 PM

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

Registration Fees
SQA Member: $395     Student: $195     Non-member: $515

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

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

• Describe the foundations of GMP Quality and Compliance
• Explain how to establish in-house operations, what to look for when outsourcing, how to maintain compliance, and how to host a inspection
• Summarize risk-based approaches to GMPs
• Describe how to access knowledge bases on various GMP topics

 Target Audience

• Quality Assurance staff who may audit or review GMP operations
• Industry Professionals who want GMP understanding
• Appropriate for individuals with 2+ years in industry
  
   

Agenda
Introducing cGMPsHistory behind GMPs
GMP Regulations: U.S., E.U., Canada and Rest of World
Enforcement in the GMPs
GMP Operations
GMP Quality Systems

Material and Manufacturing Systems
Clinical versus Commercial GMPs
GMP Laboratories: Analytical Development and Quality Control
Stability Testing Laboratories
Microbiology Laboratories and Sterility Testing
Outsourcing GMP Operations
GMP Quality Agreements
Common GMP Software
The link between GMPs and Pharmacovigilance
Auditing GMPs
Types of GMP audits
General audit technique
Assessing Compliance, Business and Regulatory Risk
Hot Topics: Emergency Use Authorization, relaxing of the DSCSA, Data Integrity
Validation
Equipment Qualification
Metrology
Facilities and Utilities
Process Validation
Cleaning Validation
Method Validation
Compendial Methods
Software Validation
Data Integrity
Understanding Data Integrity
ALCOA plus
Data Governance and Lifecycle
GMP Inspections
What to expect?
What are the boundaries?
Proper Preparation and Execution
The random factors
Writing a 483 Response

RQAP Re-registration Units:  8 non-GCP, non-GLP
 

12 — CSV 206: Implementing and Validating 21 CFR Part 11 Compliant e-Signatures

Monday, 28 September 2020, 9:00 AM - 1:00 PM

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

Registration Fees
SQA Member: $225     Student: $105     Non-member: $305

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 ofthese types of systems. 

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

• Explain 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
• Describe 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. 

RQAP Re-registration Units:  4 GCP, GLP
 

13 — GEN 101: QA Consulting

Monday, 28 September 2020, 2:00 PM - 6:00 PM

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

Registration Fees
SQA Member: $225     Student: $105     Non-member: $305

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

Objectives
At the end of 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.
• Identify sponsor's (your client) expectations, needs and methods of interactions.
• Summarize what laboratories/CROs expect from you.
• Describe how to be a valuable consultant

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

Agenda

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

RQAP Re-registration Units:  4 non-GCP, non-GLP
 

14 — GCP 301: Advanced Training

Monday, 28 September 2020, 9:00 AM - 6:00 PM

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

Registration Fees
SQA Member: $395     Student: $195     Non-member: $515

Description
This interactive course will provide experienced GCP QA professionals with advanced GCP QA tools to incorporate into how they perform audits, training and GCP support within their roles. This course has been designed to provide best practices and audience participation activities that highlight the experience of the presenters and the attendees.

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

• Incorporate presented professional development and advanced audit and training techniques into their roles.
• Incorporate current regulations and guidelines that impact GCP into their roles.
• Explain what laboratories/CROs expect from them.
• Describe and implement a quality management system approach into their roles.

 Target Audience
GCP Professionals with minimum 2 years GCP experience. If beginners wish to attend, it’s HIGHLY recommended they attend the Basic GCP course prior.
 
Agenda

1. Quality Management Systems in GCPs
2. Quality Management System (QMS), GCP Risk Management (RM), Root Cause Analysis (RCA) & CAPA (includes exercise)
3. Data Obtained from Sources other than Traditional Clinical Trials from GCP Perspective
4. Additional Auditing Strategies
5. Interview Techniques
6. Collecting and Assessing QA Metrics
7. Q&A

RQAP Re-registration Units:  8 GCP, non-GLP
 

15 — GCP 202: Hot Topics & Industry Trends

Tuesday, 29 September 2020, 9:00 AM - 6:00 PM

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

Registration Fees
SQA Member: $395     Student: $195     Non-member: $515

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

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

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

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

Agenda

1. E6(R2) Vendor Management Expectations and Best Practices (Pam Dellea-Giltner)
2. FDA BIMO Case Study (Chrissy Cochran)
3. COVID-19-Related Guidance Documents (Chrissy Cochran)
4. Important Considerations for Emerging Technologies such as AI, Block Chain and Machine Learning in Clinical Research (David Vulcano)
5. Root Cause Analysis and CAPA presentation and exercise (Lee Truax-Bellows)

RQAP Re-registration Units:  8 GCP, non-GLP
 

16 — GEN 106: Auditor's Primer: Chromatography & Mass Spectrometry

Tuesday, 29 September 2020, 9:00 AM - 1:00 PM

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

Registration Fees
SQA Member: $225     Student: $105     Non-member: $305

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.

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

• Identify different chromatographic techniques, their basic theory, and applications in a bioanalytical laboratory
• Discuss mass spectrometry, its theory and applications
• Define key chromatographic and mass spectrometry terms
• Provide guidance on failure investigations
• Use their newly gained understanding to better audit small molecule bioanalytical data

Target Audience
This course is for any quality assurance professional interested in understanding the science and auditing skills of bioanalytical chromatography and mass spectrometry. It will also cover incurred sample reanalysis and conducting failure investigations. This course is intended for beginner to intermediate level quality assurance professionals.

Agenda

1. Background (history) and types of chromatography
2. Theory and practice of HPLC/UPLC/GC
3. Theory and practice of mass spectrometry
4. Incurred Sample Reanalysis (ISR)
5. Failure investigations
6. Lunch break
7. Auditing chromatographic data
8. Auditing mass spectrometry data
9. Problem Based Learning, Hands-On Exercise

RQAP Re-registration Units:  4 GLP, GCP