1 - Basic Training: Good Laboratory Practice
Sunday, 25 April 2010, 8:00 am to 5:00 pm
Member Rates: $380 before 26 March, $440 after 26 March
Nonmember Rates: $495 before 26 March, $555 after 26 March
Session Chair: Kimberly S Frazier, Pfizer, Inc
Speakers: TBD
Target Audience:
This course is directed towards new GLP auditors, study directors, monitors, coordinators, scientists, technical staff, supervisors and management involved with GLP studies. The course could also serve as a refresher for more experienced GLP auditors and study personnel.
Course Objectives:
The attendee will gain an understanding of the history behind the development of the Good Laboratory Practice regulations.
The attendee will gain a basic understanding of the principles of the Good Laboratory Practice regulations.
The attendee will gain an understanding of the effects of non-compliance with the Good Laboratory Practice regulations.
Course Description:
This full day basic training course offers a comprehensive and practical approach to the Good Laboratory Practice (GLP) FDA and EPA (FIFRA and TSCA) regulations and standards. The course includes examples and an exercise in the application of the regulations. The course is designed for individuals associated with toxicology, metabolism, residue, product chemistry and other studies conducted under the GLPs and will be presented by knowledgeable speakers.
Course Agenda:
Introduction
History and Overview of the GLPs
Scope of the GLPs - & - Definitions
Organization and Personnel
Test System Care
Standard Operating Procedures (SOPs)
Equipment and Logs - & - Test, Control and Reference Substances
Protocols
Study Conduct and Raw Data
Final Reports - & - Record Retention and Archives
Disqualification/Effects of Non-compliance - & - Inspections
Final Q&A and Closing
2 - Good Clinical Practice: Understanding the Basics (1.5-day course)
Sunday - Monday, 25 - 26 April 2010, 8:00 am to 5:00 pm Sunday and 8:00 am to 12:00 pm Monday
Member Rates: $550 before 26 March, $620 after 26 March
Nonmember Rates: $665 before 26 March, $735 after 26 March
Session Chairs: Michele P Weitz RQAP-GCP, GCP International, LLC; Jacqueline M Hevy RQAP-GCP, Amgen, Inc
Speakers: TBD
Target Audience:
Quality Assurance and Clinical Research professionals with less than 2 years of clinical research experience.
Course Objectives:
Upon course completion, the attendee shall have a solid foundational knowledge of Good Clinical Practices.
Course Description:
This is a basic course providing an overview of the fundamentals of Good Clinical Practices. Some applied knowledge is provided through exercises, but advanced concepts are not within the scope of the training.
Topics to be covered include: Principles of GCP, Adverse Events, Auditing, The Informed Consent Process, the IRB’s role, Essential Documents, Investigational Product Accountability and Source Data.
Course Agenda:
Day One:
- Principles of GCP: Why, Who and How
Essential Documents
Clinical Research Ethics: Informed Consent and Institutional Review Boards
Informed Consent Exercise
Investigational Product Management
Safety - Adverse Events: Identifying and Reporting
GCP Auditing: The Clinical Trial Site Perspective (interactive)
Day Two
3 - Basic Computer Validation (2-day course)
Sunday and Monday, 25 and 26 April 2010, 8:00 am to 5:00 on both days
Member Rates: $690 before 26 March, $770 after 26 March
Nonmember Rates: $815 before 26 March, $895 after 26 March
Session Chair: Joseph A Franchetti, JAF Consulting, Inc
Joseph A Franchetti,
Speakers: TBD
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.
Course Objectives:
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.
In addition, the course will address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process.
The attendee will become 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.
Course Description:
This is a newly designed course with new content and exercises.
The purpose of this two-day introductory workshop training session is to provide QA professionals with an overview of the validation process, regulatory expectations and auditing strategies based on industry standards and guidance. It also will provide course attendees the tools they need “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, and attendees will receive a copy of this document as part of their course fee. 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.
Course Agenda:
Course topics will provide attendees with the information on:
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 - Selected Topics in Bioanalytical Auditing
Sunday, 25 April 2010, 8:00 am to 5:00 pm
Member Rates: $485 before 26 March, $545 after 26 March
Nonmember Rates: $595 before 26 March, $655 after 26 March
Session Chair: Stephen P Endres, Pfizer, Inc
Speakers: TBD
Target Audience:
This course is designed for those new to the area of Bioanalytical Auditing (0-3 yrs experience) either in a GLP or GCP setting.
Course Objectives:
The attendee shall gain a better understanding of the role of bioanalysis in pharmaceutical development.
The attendee shall be able to audit bioanalytical data and reports, focusing on those issues that could impact the quality and integrity of the data.
The attendee shall gain a historical perspective of agency expectations with regard to method validation and bioanalytical data generation.
Course Description:
This course will cover several basic bioanalytical concepts. These include the role of bioanalysis in pharmaceutical development, commonly used analytical techniques for small and large molecules and the data generated by these methods and how to focus on those areas most likely to impact the quality and integrity of the data generated when auditing bioanalytical data and reports. Hands on interactive activities are planned.
Course Agenda:
Intro to Pharmacokinetics
Bioanalytical Method Validation
Validation of Cutting Edge Technologies
Auditing in an Electronic Environment
Improving Audit Efficiency
Interactive Session on Bioanalytical Data Auditing
5 - Biotechnology: Methodology and Auditing
Sunday, 25 April 2010, 8:00 am to 5:00 pm
Member Rates: $485 before 26 March, $545 after 26 March
Nonmember Rates: $595 before 26 March, $655 after 26 March
Session Chair: Joan M Rejda-Heath PhD, RQAP-GLP, Monsanto Company
Speakers: TBD
Target Audience:
Quality Assurance auditors with at least one year of auditing experience and a basic understanding of the structure of DNA, RNA, protein and the Central Dogma of Biology.
Course Objectives:
The attendee shall be able to:
Describe the analytical methods used to characterize DNA, RNA, and protein
Identify critical steps in characterization methods to aid in inspections and audits
Describe how to review data produced during characterization of a genetically-modified organism
Course Description:
Recombinant DNA technology is being used daily to develop new products (e.g., pharmaceuticals, crops, animals). Biotechnology is the rapidly expanding area of science that allows these developments. Topics to be discussed include:
Basic overview of biotechnology
Analytical methods used to characterize the DNA, RNA, and protein from a transgenic organism
Course Agenda:
Overview of DNA, RNA, and Protein – the Central Dogma of Biology
Genes and Gene Expression
Methods used for
Special Topics
6 (morning) and 7 (afternoon) - Public Speaking Workout (two identical 0.5-day course sections, registration limited to 15 participants per section)
Sunday, 25 April 2010, 8:00 am to 12:00 pm and Sunday, 25 April 2010, 1:00 pm to 5:00 pm
Member Rates: $385 before 26 March, $445 after 26 March
Nonmember Rates: $495 before 26 March, $555 after 26 March
*morning section eligible for 2 half-day course discount if combined with course #8
Session Chair: Kimberly S Frazier, Pfizer, Inc
Speaker: Edward M Skurka Jr, DTM, professional public speaking coach
Target Audience:
Public Speaking Workout is for any QA professional wanting or needing to enhance his/her confidence in any/all public speaking situations from one-on-one settings to meetings to major presentations. No matter what your level of speaking experience, there is something in PSWO to benefit all participants. Challenge yourself!
Course Objectives:
The participant will increase his/her knowledge, experience, understanding and practice of public speaking/communication skills through four speaking opportunities.
The participant will receive professional coaching and peer feedback.
The participant will experience “turbocharged” confidence through an enjoyable, fun team-building workshop.
The participant will be able to use new and enhanced skills immediately (PSWO is a workout, not an academic lecture).
The participant will leave with a new attitude about his/her public speaking capabilities.
Course Description:
“I wish that I’d had some training like this in school, college or earlier on in my career,” is the consensus comment from over 2,000 professionals who have experienced Public Speaking Workout. This workshop is an all-in-one combination of a physical workout (do it), a bootcamp (immersive learning), a diagnostic test (evaluate your strengths and weaknesses) and a confidence course (like a ropes course). Participants will stretch their comfort zones and turbocharge their confidence with a new perspective and enhanced skill set usable immediately. It is fun, entertaining and team-building.
Course Agenda:
Introduction to PSWO. Create level playing field, explain the format, attitude of participation, and resulting takeaways. Presentation is interactive from the opening question.
Exercise #1. 1 to 1.5 minute speaking opportunity per participant. This exercise gives participants the opportunity to demonstrate existing skills, confidence level and
ability to think on their feet with a very easy subject. It also provides the coach and audience (other participants) the opportunity to observe and hear the speaker’s skills. At the same time, all participants are building a matrix of understanding of the basic skills. Coach evaluates strong and weak skills for each and suggests improvements and tips to be pondered for the next exercise. Minimum audience feedback due to learning and coaching mode.
Exercise #2. Same timing. Evaluation and coaching are intensified. Speaker verbally analyzes his / her own performance based on increased confidence and experience and previous coaching suggestions. Confidence, presence and command are stressed. “Bold, powerful confident voice” and “Take command of this audience” are mantras. More peer feedback is encouraged. The power of multiple opinions and input from one’s peers is very helpful, beneficial and confidence building. Ample "do-over" opportunities quickly build confidence.
Exercise #3. Same timing. This the STRETCHING exercise and a keystone of PSWO training. It is the most remembered and talked about. It is an opportunity to demonstrate and exaggerate (for reinforcement) all of the basic skills that have been practiced so far - without the pressure of worrying about, "What am I going to say?" It is the exercise that changes lives and attitudes. Comfort zones get stretched to the max. It is also the most entertaining and fun exercise. Intensive coaching and ample "do-over" opportunities.
Exercise #4. Same timing. Each participant’s opportunity to demonstrate enhanced skills, attitude and confidence developed in previous exercises.
Closing comments and standing ovation for all.
8 - From Lab to Market: Getting Regulatory Approval (0.5-day course)
Sunday, 25 April 2010, 8:00 am to 12:00 pm
Member Rates: $335 before 26 March, $395 after 26 March
Nonmember Rates: $445 before 26 March, $505 after 26 March
*eligible for 2 half-day course discount if combined with course #6
Session Chair: Martha Bennett, Bennett and Company
Speakers: TBD
Target Audience:
This course is an overview for the QA professional (GLP, GCP, and GMP) who would like a general understanding of the path for getting a product approved by FDA. What types of studies are required? What questions are being asked and answered? Which regulations apply at the different stages?
Course Objectives:
Participants shall be able to describe the steps for regulatory approval.
Participants shall be able to identify the appropriate regulations that apply to the steps in the process.
Participants shall be able to name similarities and differences in the process for various types of products.
Course Description:
This course will present an overview of the regulatory steps in getting a product approved by FDA. It will highlight the review process and applicable regulations.
Course Agenda:
9 - Introduction to SQA Leadership (0.5-day course, complimentary for SQA members)
Sunday, 25 April 2010, 1:00 pm to 5:00 pm
Member Rates: complimentary for all SQA members
Session Chair: Catherine Bens, Integrated Quality Management
Speakers: Members of the SQA Board of Directors and the SQA Executive Director
Course Description:
The SQA Board of Directors has created this course for SQA members. The objectives of the course are 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;
Provide SQA leadership with an overview of responsibilities and an understanding of how SQA is governed;
Provide SQA members who are considering running for election or volunteering on Committees or within Specialty Sections with an understanding of the requirements and responsibilities of the positions and the resources and assistance SQA offers to support those positions;
Provide an opportunity to meet and network with past, current and future SQA leaders; and
Provide opportunities to develop and discuss leadership concepts through fun group exercises.
10 - Current Topics in Good Laboratory Practice
Monday, 26 April 2010, 8:00 am to 5:00 pm
Member Rates: $485 before 26 March, $545 after 26 March
Nonmember Rates: $595 before 26 March, $655 after 26 March
Session Chair: Matthew A Foster RQAP-GLP, MPI Research, Inc
Speakers: TBD
Target Audience:
Quality Assurance professionals with two or more years of auditing experience in the GLP environment.
Course Objectives:
The participant shall be able to expand on existing knowledge of the GLP regulations to improve auditing and interpretation skills.
The participant shall be able to expand auditing skills beyond basic study auditing to facility, qualification, and validation auditing.
The participant shall gain insight into the current topics of Medical Device and Bioanalytical auditing.
Course Description:
With a basic knowledge of the GLPs in your auditing toolbox, it is time to move to the next level. This one-day session will focus on a deeper understanding of the FDA, EPA, and OECD regulations as they pertain to evolving expectations and industry standards. The session will take an interactive approach to understanding the regulations including “hot topics” in auditing, bioanalytical auditing, and quality systems auditing, and medical devices. This session is intended for QA professionals with 2 years or more of GLP experience.
Course Agenda:
The Evolution of the GLPs: Preambles, Advisories and Q&A
Quality Systems Auditing: Facility, Qualification and Validation Auditing
Medical Device Current Events and Topics
Bioanalytical Current Events
Hot Topics in Auditing
11 (first section) and 12 (second section) - Preparing for and Hosting a Government Inspection (two identical 2-hour course sections, no lunch provided with either section)
Monday, 26 April 2010, 1:00 pm to 3:00 pm and Monday, 26 April 2010, 3:30 pm to 5:30 pm
Member Rates: $195 before 26 March, $255 after 26 March
Nonmember Rates: $305 before 26 March, $365 after 26 March
Session Chair: Nancy A Catricks MS, Charles River Laboratories
Speakers: Nancy A Catricks MS, Linda Palagi Lynn RQAP-GLP
Target Audience:
QA professionals who must prepare for a government inspection
Course Description:
Hosting a government authority inspection is a learned process. The SQA is offering a 2 hour training session on how to host an inspection. This training will also include how to prepare your site and staff for the inspections, gathering documents, preparing for interviews, and responding to inspection findings. Additionally, role play scenarios will be performed to allow participants the experience of participating in an inspection. This industry best practice training session will help you prepare for and host a government authority inspection.
Course Agenda:
Prepare for a Government Inspection
Host a Government Inspection
Learn Industry Current Best Practices and Techniques
Role Play
13 - Delivering High Quality GLP and vGCP Animal Studies (0.5-day course)
Monday, 26 April 2010, 8:00 am to 12:00 pm
Member Rates: $335 before 26 March, $395 after 26 March
Nonmember Rates: $445 before 26 March, $505 after 26 March
*eligible for 2 half-day course discount if combined with course #14
Session Chair: Marci Jae Murphy RQAP-GLP, Boehringer Ingelheim Vetmedica, Inc
Speakers: TBD
Target Audience:
Quality Assurance professionals with one or more years of experience who are familiar with vGCP and/or GLP regulations. Study Directors, Clinical Investigators, Monitors, Regulatory Affairs and contract facility personnel will also benefit from this session.
Course Objectives:
The participant shall be able to identify key requirements for GLP and vGCP protocols, reports and data packages/study files.
The participant shall be able to apply key elements of critical phase and facility audits.
The participant shall be able to clearly communicate findings and evaluate audit responses – identifying whether appropriate corrective action has been taken.
The participant shall be able to describe training requirements, documentation and how to audit to assure appropriate training was completed.
The participant shall be aware of resources available to answer questions.
Course Description:
This course will provide participants with a concrete foundation of the requirements necessary to audit protocols, reports and facilities for compliance to either GLP or vGCP requirements. It will also cover corrective actions focusing primarily on evaluating responses to internal audits. Though the course will be from an animal health study perspective, it will include universally applicable practices. This interactive course will discuss issues and provide best practices and auditing tips to help participants apply the objectives.
Course Agenda:
Key elements required and common problems encountered in protocols, reports, and data packages / study files (GLP and vGCP)
Key elements of critical phase and facility audits
Describing your audit findings and evaluating the responses
Training – requirements, documentation, auditing
GLP and vGCP resources available
Q&A
14 - Addressing Challenges to Achieve High Quality GLP and vGCP Animal Studies (0.5-day course)
Monday, 26 April 2010, 1:00 pm to 5:00 pm
Member Rates: $335 before 26 March, $395 after 26 March
Nonmember Rates: $445 before 26 March, $505 after 26 March
*eligible for 2 half-day course discount if combined with course #13
Session Chair: N Brent Conatser, Elanco Animal Health
Speakers: TBD
Target Audience:
Experienced Quality Assurance professionals, Study Directors, Monitors, Regulatory Affairs professionals, and contract facility personnel. Those who have participated in the morning half-day session, “Delivering High Quality GLP and vGCP Animal Studies” will also benefit from this more advanced session.
Course Objectives:
The participant shall be able to understand the regulatory perspective when evaluating protocols and reports, including:
The participant shall be able to audit statistical outputs and data sets.
The participant shall be able to apply hard and soft skills for third-party facility inspections (agency, sponsor, etc.), including hosting the inspection and identifying appropriate corrective actions.
The participant shall learn current trends in 483s and strategies for implementing corrective/preventative actions.
Course Description:
This course will be interactive and focus on regulatory agency expectations when reviewing and auditing protocols, reports and facilities for animal health studies. Corrective action topics will include how to prepare responses to third party (including regulatory agency) inspections. Though the course will be from an animal health study perspective, many of the topics/practices discussed will be universally applicable.
Course Agenda:
Regulatory agency expectations for protocols, data packages, reports and submissions
Auditing statistical outputs
Hosting and responding to third-party inspections (agency, sponsor, etc.)
Recent 483s and implementing corrective/preventative actions
Q&A
15 - Personal Development and Effectiveness for Quality Assurance Professionals
Monday, 26 April 2010, 8:00 am to 5:00 pm
Member Rates: $485 before 26 March, $545 after 26 March
Nonmember Rates: $595 before 26 March, $655 after 26 March
Session Chair: Anthony B Jones, Taylor Technology, Inc
Speakers: TBD
Target Audience:
This course is intended for all QA professionals.
Course Objectives:
After completion of this session the participant will have:
Enjoyed the day, participated and had fun.
A clearer vision and defined direction for their professional activities, incorporating new ideas on work/life balance.
Reflected on priorities and re-defined these as necessary.
Identified activities that will provide the key to future professional and personal development.
Identified activities that are impediments to development with a plan to reduce or discontinue these.
Course Description:
This training session takes a fresh look at how to be truly effective; getting the best results for the time and effort invested, a topic that has never been more pertinent. Effectiveness is a critical concept for Quality Assurance, we must fulfill our regulatory obligations to assure compliance and data quality in a resource-efficient manner without impeding drug development. This session takes a quality-based approach to meeting these challenges by defining the ‘root causes’ of effectiveness, demonstrating how these can be applied to improve performance. The concepts covered are simple and universal, applying to both professional and personal life, forming a foundation upon which other skills can be built.
Course Agenda:
Introduction, Course Objectives
Foundations, Balance
Direction and Goals
Effectiveness, Priority, Risk
Distractions and Limitations
Empowerment of QA
16 - Understanding the GxPs: Bridging the Communication Gap
Monday, 26 April 2010, 8:00 am to 5:00 pm
Member Rates: $485 before 26 March, $545 after 26 March
Nonmember Rates: $595 before 26 March, $655 after 26 March
Session Chair: Melissa M Eitzen MS, RQAP-GLP, University of Texas Medical Branch
Speakers: TBD
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 the GxPs will gain an understanding and appreciation of the differences and commonalities that are shared with colleagues who work in other specialty areas.
Course Objectives:
The attendee shall be able to:
Appreciate regulatory specialty areas outside their scope of expertise
Understand differences in terminology used within specialty areas
Recognize commonalities and regulation overlaps between specialty areas
Understand the regulatory framework
Identify industry trends within specialty areas
Course Description:
The course is designed to broaden/promote a better understanding of the various GxP regulations among QA professionals in order to improve communication among SQA members, sponsors, regulatory agencies, and CROs. The course includes an overview of the regulatory framework followed by presentations on the GLP (focus on FDA-GLP), GLP Efficacy studies (Animal Rule), human GCP, veterinary GCP, GMP, GCLP, Medical Device, and Good Tissue Practice (GTP) regulations. Course presentations are designed with a common matrix so that all speakers address regulation and auditing commonalities, differences, overlaps, and industry trends. Question and Answer sessions promote open discussions with attendees, and course materials include a glossary of terms.
Course Agenda:
Welcome and Overview
GLP
GLP: Animal Rule
Human GCP
Veterinary GCP
GCLP
GMP
Medical Device
GTP
Q&A/Discussion
17 - Advanced Topics in GCP: A Global GCP QA Workshop and Seminar
Friday, 30 April 2010, 8:00 am to 5:00 pm
Member Rates: $485 before 26 March, $545 after 26 March
Nonmember Rates: $595 before 26 March, $655 after 26 March
Session Chairs: Cheryl M McCarthy CQA, Eliassen Group; Lee Truax-Bellows RQAP-GCP, Norwich Clinical Research Associates Ltd
Speakers: TBD
Target Audience:
GCP Professionals with 2 or more years of experience
Course Objectives:
The attendee shall be able to understand the impact of Global requirements for QA Professionals
The attendee shall be able to incorporate presented professional development , audit and training techniques into their roles
The attendee shall be able to understand the current status of Regulations that impact GCP (FDA/Regulatory Rep to present)
Course 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.
Course Agenda:
Topics to be covered include:
Regulatory Updates
Audits – Advanced tools and techniques in the auditors toolbox
Risk Management
Quality Systems Approach to Product Development
Corrective Action/Preventative Action Management
Vendor Management
18 - Auditing Software and Data Providers (0.5-day course)
Friday, 30 April 2010, 8:00 am to 12:00 pm
Member Rates: $335 before 26 March, $395 after 26 March
Nonmember Rates: $445 before 26 March, $505 after 26 March
*eligible for 2 half-day course discount if combined with course #19 or #23
Session Chair: Joseph A Franchetti, JAF Consulting, Inc
Speakers: TBD
Target Audience:
This course is designed for validation, quality, IT, and business personnel responsible for auditing regulated computer systems in the pharmaceutical, biotech and medical device industries. The course is more advanced in nature and would be beneficial if basic auditing techniques are understood. The course is especially designed for attendees seeking a thorough understanding of quality systems and its implementation in the software development process.
Course Objectives:
After this course, the attendee will be able to describe:
the purpose and goals of a vendor audit;
how to prepare for a vendor audit;
suggested approaches for conducting vendor audits with regard to evaluating SOPs, system development deliverables, maintenance and support in relation to industry standards;
how to develop an audit checklist; and
how to develop an audit report and corrective action plan.
Course Description:
This half-day session focuses on the activities associated with planning and completing audits of computerized system providers both internally and externally. In this session, the participants will gain an understanding on what to look for in the evaluation of the software development deliverables and quality systems.
19 - Process Mapping (0.5-day course)
Friday, 30 April 2010, 1:00 pm to 5:00 pm
Member Rates: $335 before 26 March, $395 after 26 March
Nonmember Rates: $445 before 26 March, $505 after 26 March
*eligible for 2 half-day course discount if combined with course #18 or #22
Session Chair: Beth A Galt, MPI Research, Inc
Speakers: Beth A Galt, Jack Balsinger, Lisa A Morrison RQAP-GLP, Klaus Goodwin-Pfister, Becki C Nowatzke
Target Audience:
This course is designed for those new to Process Mapping in a GxP environment. This course can benefit anyone from authors, reviewers, or those who simply follow Standard Operating Procedures; to individuals responsible for process planning and quality improvements.
Course Objectives:
The attendee shall gain a better understanding of the benefits and uses of process maps.
The attendee shall be able to create both workflow maps and SIPOC maps.
The attendee shall gain knowledge of how to analyze, evaluate, and validate processes.
Course Description:
This course will cover the steps to identify and map processes. Included will be training on "how" and "why" to map processes for work flows and for understanding the purpose and scope of a process through SIPOC mapping. Additional discussion of analysis, evaluation, and validation of processes using process maps will be provided. Five hands-on interactive activities/exercises are planned.
Course Agenda:
Defining processes
Benefits of process mapping
Steps to map a process
Understanding types of process maps
Create a workflow map
Create a SIPOC map
Use the process map to analyze, evaluate, and validate a process
20 - Continual Quality Improvement: Expanding the QA Toolbox
Friday, 30 April 2010, 8:00 am to 5:00 pm
Member Rates: $485 before 26 March, $545 after 26 March
Nonmember Rates: $595 before 26 March, $655 after 26 March
Session Chair: Jo Ann Boyd, Southwest Research Institute
Speakers: Richard M Siconolfi, Catherine Bens, Jo Ann Boyd
Target Audience:
QA managers, auditors, test facility managers, regulatory affair managers
Course Objectives:
Introduce the concept of Continuous Improvement and the benefits of such a program for GxP facilities, activities, studies, etc.
Review some key tools that have been highly successful in quality improvement.
Present these tools in enough detail including actual applications and engaging in interactive exercises that will participants to use these tools in their own work environment.
Course Description:
This course will provide an overview of recognized quality management tools that have been successfully deployed in business management today. The Research QA profession as a whole has not historically utilized these tools and QA professionals may have little to no formal training in continuous improvement methods to be aware of their value in assessing and improving the impact and value of the QAU to any organization. This course will review basic problem solving and statistical tools used in systematic approaches to continuous improvement programs. Emphasis will be on value-added assessments and in learning quality concepts, principles and practices of the fundamental tools. Participants will learn how to determine which tool to use for which situation and participate in problem solving exercises using the tools. In-depth presentations on a number of fundamental tools will be provided including:
Each tool will be presented as an interactive module which will include a detailed description of the tool, its history in the business world, its strengths and weaknesses and appropriate application, and examples of its use in the quality system. Extended opportunity to work with each tool and discuss its applications will be provided through small group activities and exercises.
21 - Non-Clinical Medical Device Compliance in a Changing Climate
Friday, 30 April 2010, 8:00 am to 5:00 pm
Member Rates: $485 before 26 March, $545 after 26 March
Nonmember Rates: $595 before 26 March, $655 after 26 March
Session Chair: Cynthia R Ivey MS, RQAP-GLP, Surpass, Inc
Speakers: TBD
Target Audience:
GLP medical device professionals of all experience levels
Course Objectives:
Participants in this training session will:
Gain a better understanding of the current GLP medical device regulatory climate
Receive insight into navigating the compliance challenges facing the GLP medical device industry
Learn new methods to approach spreadsheet validation and tracking
Expand understanding of international GLP device regulations and requirements
Course Description:
Confused about GLP in medical devices? The GLP medical device industry is encountering many challenges – old and new. This one-day session is devoted to addressing the current compliance climate and providing tools relevant to the circumstances facing non-clinical medical device professionals.
Course Agenda:
Topics may include:
FDA requests relating to protocol development, animal health, raw data, and study reports
Equipment hot topics:
International device regulations (tentative)
GLP medical device case studies
22 - Creeping GMPs (0.5-day course)
Friday, 30 April 2010, 8:00 am to 12:00 pm
Member Rates: $335 before 26 March, $395 after 26 March
Nonmember Rates: $445 before 26 March, $505 after 26 March
*eligible for 2 half-day course discount if combined with course #19 or #23
Session Chair: Allan Klein PhD, West Chester University
Speakers: TBD
Target Audience:
GLP and GCP auditors or study directors with 2 or more years of experience
Course Objectives:
The participant shall be able to understand how the GMP regulations could apply to and impact GLP or GCP studies.
The participant shall acquire knowledge of what an auditor should look for in regards to GMP compliance to support such studies.
The participant shall obtain practical instruction on potential GMP requirements through participation in a practical case study.
Course Description:
The regulatory expectations for study compliance continue to broaden and knowledge of all potential inspectional requirements is now necessary. Current GLP and GCP project compliance most often now requires some degree of GMP documentation as well. This course shall provide an overview of the GMP requirements that could impact compliance for GLP and GCP projects. Practical exercises are included to enable the participants to understand some of the GMP regulatory ramifications.
Course Agenda:
Introduction and Icebreaker
Compliance: Assumptions & Definitions
GMPs for GLP & GCP Studies: When do they apply?
What We Do in Practice : What Should an Auditor Look For?
EU versus FDA GMP Requirements
Mock Study Case Exercises
Wrap-Up: Q & A
23 - GLP in the Bioanalytical Lab: An Intended Purpose Approach from Good Science towards Compliance (0.5-day course)
Friday, 30 April 2010, 1:00 pm to 5:00 pm
Member Rates: $335 before 26 March, $395 after 26 March
Nonmember Rates: $445 before 26 March, $505 after 26 March
*eligible for 2 half-day course discount if combined with course #18 or #22
Session Chair: Christopher R Tudan PhD, BioAccurate Enterprises, Inc
Speakers: TBD
Target Audience:
This course targets both QA professionals and scientists who are associated with the bioanalytical laboratory. The audience is from both sponsor sites and the CRO, and is applicable to staff who validate and audit bioanalytical methods including LC-MS/MS. LBA and flow cytometry.
Course Objectives:
The objective of this course is to provide in-depth training on the “Intended Purpose” approach to Bioanalytical Method Development and Validation as supported by the recent Crystal City meetings and pertinent white papers. I will lead (and support) discussions on the currently accepted concepts and criteria for the development and validation (or qualification) of bioanalytical methods that are GLP/GCP compliant. Specific case studies and raw data examples are used to illustrate method development strategies and successful implementation of validation efforts towards rapid and compliant validation processes that are conducive to robust and efficient sample analysis. Finally, effective approaches to the technical review of raw data, including the acceptance and rejection of data, will be utilized towards the end of the course to cement the points considered earlier in the day.
Course Description:
1. FDA Guidance Recommendations for Method Validation
2. Validating a Bioanalytical Method:
a. Method Validation performance characteristics
b. Validation experiments
c. Validation criteria – Today’s standards (current expectations)
d. BA Validation parameter requirements – Addressing test requirements and criteria of each Validation experiment
e. Reference Standards
f. System Suitability
3. LBAs - Recommendations for Fitting Non-linear Calibration Curves, Selectivity, Pre-study Validation versus In-study Validation, Specific Nonselectivity versus Nonspecific Nonselectivity (i.e., Assessing Parallelism)
4. Incurred Sample Reanalysis and Sample Reanalysis/Repeats
5. Partial versus Cross Validations – Changes in Validation Parameters versus Respective Minimal Experimental Requirements and Criteria
6. Method Development – Recommendations/Strategies to Facilitate a Rapid and Compliant Validation Process
7. What Should You Be Looking for in the LC-MS/MS Raw Data? - Interpreting Chromatography, Scans, Spectra, Response Measures and Method Parameters that Impact the Data
8. Technical Review of Raw Data
9. Bioanalytical Study Plans
10. Validation Report Components
Course Agenda:
FDA Guidance’s in Method Validation
Method Development and Validations in the LBA Lab
Method Validation Experiments and Parameters and Acceptance Criteria
How is LC-MS/MS Data Derived? What should I be looking for in the raw data?
Partial Validations
ISR and Sample Repeats
Bioanalytical Study Plans/Validation Reports