SQA September 2022 Quality College

Online and in Raleigh, NC, USA

Course Descriptions

 

1 — CSV 103: What Do Data Integrity and the Organizational “Immune System” Have in Common? (Two-day, Virtual only)

Wednesday and Thursday, 14 and 15 September 2022, 10:00 AM-1:30 PM EDT each day

Registration Rates
  • By 29 August 2022:  Member $360,  Non-member $460,  University Members $265,  Student/Outreach Members $180
  • After 29 August 2022:  Member $385 , Non-member $495,  University Members $285,  Student/Outreach Members $180
        Register Online
 
RQAP re-registration units: 6.00 GCP, GLP*
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Galit Lisaey, Gal.IT Data Integrity Consulting

Description
The importance of maintaining the quality and reliability of the data (data integrity) submitted to the authorities, especially in the field of pharmaceuticals, has become a binding requirement. The past thirty years have witnessed a global transition to computerized, automated systems and software. To ensure that critical electronic data presented to the authorities as a basis for decision-making are accurate and reliable, some methodical official guideline documents have been written by the health authorities. A guideline document on behalf of the US Health Authority called FDA 21 CFR Part 11 was published in the early 1990s, and it was followed by other documents such as EU Annex 11 for the European authorities, as well as similar documents for the Canadian, Australian, and International Health Authorities, among others. Between the years 2013 and 2021, the guidelines have been updated and started to focus more on data integrity than ever before.

Data integrity (DI) training has become a mandatory requirement for any organization committed to this subject. This course is intended to suggest ways to implement DI principles fundamentally within an organization.

 
Objectives
At the end of this course, the participant shall be able to:
  1. Manage and implement DI requirements such as change controls and computer system validation projects
  2. Explain the rationale behind the required regulations
  3. Initiate and perform internal audits related to DI
  4. Manage external audits related to DI with vendors
  5. Maintain and oversee the overall data integrity process
     

Target Audience
GLP/GMP and or GxP QA auditors; GxP Business and Systems Owners; Technical Systems Owners (IT or Business); Quality Control professionals; Compliance team members and managers; and Data Scientists with 2 or more years of experience

Agenda
Day One: A historical overview of the development of the requirements dealing with maintaining the quality and reliability of data. It includes a comparison of the various regulations, as well as recommendations for the successful implementation of a shared organizational culture.
1. Data Integrity vs. the immune system - Quality Culture for Data Integrity
2. Regulatory Update - Diving into Data Integrity basic aspects
3. Implement Risk Management and residual risks methodology as the fundamental aspect

Day Two: Project management methodology overview, using case studies to analyze the challenges dealt with by managers. Working with recommended work plan templates to create a harmonious and effective workflow. Building a tailored and stable work plan including overall maintenance control tools. The goal is to become familiar with project management.
4. Managing CSV as a project
5. Practice templates
6. Validation as continuous improvement – effective tools for managing the day after validation, including investigation as a constructing activity.

2 — GLP 101: Basic Training (Two-day, In person only)

Monday and Tuesday, 19 and 20 September 2022, 8:00 AM-5:00 PM EDT each day

Registration Rates
  • By 29 August 2022:  Member $795,  Non-member $945,  University Members $585,  Student/Outreach Members $375
  • After 29 August 2022:  Member $855 , Non-member $1,005,  University Members $645,  Student/Outreach Members $375
        Register Online
 
RQAP re-registration units: 16.00 GLP or non-GCP*
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Barb Munch, Munch GLP Consulting; Gina Tucker RQAP-GLP, JAF Consulting; Lori Wright RQAP-GLP, StageBio; Greg Furrow, MustangBio; Beth Moulaison, Vertex; Sara Rybak RQAP-GLP, Charles River; Johanna Mazlo PhD, RQAP-GLP, IR-4 Project; Tim Valley, LabCorp Drug Development; Tom Purdue RQAP-GLP, Boehringer Ingelheim Pharmaceuticals; Theresa Donegan MS, Rubius Therapeutics; Karen Waetjen RQAP-GLP, Amgen; Eric Pittman, US FDA

Description
This course is a comprehensive review of the FDA GLPs and offers topical comparisons between FDA and EPA requirements. It also provides a brief overview of the OECD Principles of GLP.
 
Objectives
At the end of this course, the participant 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 EPA and FDA GLPs and identify topical differences between FDA and EPA requirements
  • 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
All levels of GLP experience
 
Agenda
  1. Basic GLP training introduction
  2. Landmark cases in the development of GLPs
  3. Organization of GLPs
  4. Scope and Definitions
  5. Shall or Should (Legal terminology[m1] [GT2])
  6. Contracts & Inspections
  7. Organization and Personnel
  8. Facilities
  9. Equipment
  10. SOPs, Reagents & Solutions, Animal Care
  11. Test and Control Articles
  12. Protocol
  13. Conduct of Nonclinical Laboratory Studies
  14. Reporting
  15. Storage, Retrieval, and Retention
  16. OECD Principles and Mutual Acceptance of Data
  17. Electronic Records
 

3 — GCP 102: An Introduction to Good Clinical Practice (One-day, In person only)

Monday, 19 September 2022, 8:00 AM-5:00 PM

Registration Rates
  • By 29 August 2022:  Member $495,  Non-member $615,  University Members $375,  Student/Outreach Members $255
  • After 29 August 2022:  Member $545 , Non-member $665,  University Members $425,  Student/Outreach Members $255
        Register Online
 
RQAP re-registration units: 8.00 GCP or non-GLP*
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters

Jenny O'Brien PhD, RQAP-GCP, O'Brien CQA; MaryEllen Lander RQAP-GCP, Elevar Therapeutics; Dani Eaton RQAP-GCP, Rubius Therapeutics; Dawn Niccum RN, MSN, CCRA, RQAP-GCP, InSeption Group, Chrissy Cochran, Phd, FDA

Description
This one-day course will review the evolution of GCP and applicable regulations and guidelines. It will introduce the participants to the applications of GCP to investigator and service provider audits.

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

  • Define Good Clinical Practice
  • Cite events impacting the evolution of GCP
  • Familiarity with 21 CFR Parts 11, 50, 54, 56, 312 and ICH E6

Target Audience
Individuals that are new to the GCP QA profession or transitioning to GCP from the GLP or GMP profession.

Agenda

1. Define Good Clinical Practice
2. Cite key events impacting the evolution of GCP
3. Familiarity with 21 CFR Parts 11, 50, 54, 56, 312, and ICH E6

 

4 — GEN 110: Better Presentation Skills: The Art of Persuasion (Half-day, In person)

Monday, 19 September 2022, 8:00 AM-12:00 PM

Registration Rates
  • By 29 August 2022:  Member $310,  Non-member $410,  University Members $225,  Student/Outreach Members $145
  • After 29 August 2022:  Member $370,  Non-member $470,  University Members $285,  Student/Outreach Members $145
        Register Online
 
RQAP re-registration units: 4.00 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.

Presenters
Steve Gompertz, QRx Partners
 
Description
Often, nothing strikes more terror into the hearts of otherwise competent professionals than being asked to present information to an audience. The challenge of effectively presenting information is about more than just being able to stand in front of a room and speak clearly. It begins like most endeavors with planning and preparation. Besides knowing the topic, good presenters know their audience so that they can anticipate not only what the audience will want to know, but also how they will want to hear it and what they might question. In this way, presenters will be able to build good presentation materials and be more confident once they are in front of the audience. Building good materials is also fraught with danger in that even good information presented in a poor format will result in losing the audience’s confidence in the presenter and missing important messaging. Presenters often forget that the most valuable part of the presentation is them, and as a result try to cram too much information into each slide, or choose distracting or ineffective ways to convey concepts. Once actually in front of the audience, speaking style becomes the key to success. We can all likely think of a presentation that was almost painful to watch as well as one that was so smooth that we wondered with admiration how someone got to be so good. This session is intended to address all of these fears, misconceptions, and bad experiences by presenting tips and tricks that, with practice, can help anyone become more persuasive and influential with audiences large and small.
 
Objectives
At the end of this course, the participant shall be able to:
  • Deliver competent presentations with confidence
  • Calculate the amount of preparation required to deliver a competent presentation
  • Prepare effective presentation materials
  • Develop a “game plan” for before, during, and after a presentation
  • Describe how the new “Zoom” world changes presentation techniques

Target Audience
Anyone who needs to get better at presentations to audiences large or small.

Agenda
  • What Not to Do
  • Getting Prepared to Present
    • Preparation
    • More Preparation
    • And More Preparation
    • Yup, More Preparation
    • Visualizing Your Message
    • Good Presentation Structure
    • Slide Content & Formatting
  • Delivering Your Message
    • Get Off to a Good Start
    • Make a Good Impression
    • Connect
    • Keeping the Audience Engaged
    • Wrapping It Up
  • Tips for Virtual Presentations
    • Equipment
    • Camera Positioning
    • Background Images
    • Audio Considerations

 

5 — GEN 209: Guerilla Tactics for Quality Leadership (Half-day, In person only)

Monday, 19 September 2022, 1:00 PM-5:00 PM

Registration Rates
  • By 29 August 2022:  Member $310,  Non-member $410,  University Members $225,  Student/Outreach Members $145
  • After 29 August 2022:  Member $370,  Non-member $470,  University Members $285,  Student/Outreach Members $145
        Register Online
 
RQAP re-registration units: 4.00 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.

Presenters
Steve Gompertz, QRx Partners; Jackie Torfin, QRx Partners

Description
The term “guerilla tactics” likely conjures images of ragtag armed fighters skulking about the jungle to ambush a better outfitted target. A better definition in the context changing your organization’s culture around quality is that of a member of a small independent group taking part in activities performed in an impromptu way, often without authorization. In business we would more typically refer to such people as mavericks, leaders, change agents, or even loose cannons, heretics, or disrupters. Regardless of which of those labels you consider positive or negative, the common theme is that they are people with strong convictions who persist and succeed in driving change.

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

  • Implement new quality methods and concepts without conflict
  • Obtain the data needed to drive analysis and decision making efficiently and without bias
  • Create documentation that will ensure better comprehension and compliance
  • Apply the “7 habits of highly effective quality leaders

Target Audience
Anyone, whether in a formal leadership position or not, who wants to improve on making meaningful change happen and stick.

Agenda
  • What are “Guerilla” Tactics?
  • Common Quality Leadership Challenges
  • Hide the Vegetables
  • Teaching new concepts without anyone realizing it
  • Measurement Without Fear
  • Measuring Processes Rather Than People
  • Less is More Documentation
  • Applying Lean Thinking to Documentation
  • The 7 Habits of Highly Effective Quality Leaders
  • Stephen Covey’s Insights Applied to Quality Leadership
 

6 — GCP 201: Hot Topics & Industry Trends (One-day, In person)

Tuesday, 20 September 2022, 8:00 AM-5:00 PM 

Registration Rates
  • By 29 August 2022:  Member $495,  Non-member $615,  University Members $375,  Student/Outreach Members $255
  • After 29 August 2022:  Member $545,  Non-member $665,  University Members $425,  Student/Outreach Members $255
        Register Online
 
RQAP re-registration units: 8.00 GCP or non-GLP*
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters
Glenda Guest RQAP-GCP, Assured of Quality Consulting & Training; Lee Truax-Bellows RQAP-GCP, NCRA; Angela Bazigos, Touchstone Technologies Silicon Valley; Pam Dellea-Giltner RQAP-GCP, PDG Clinical Consulting; Chrissy Cochran PhD, US FDA
 
Description
This interactive workshop with expert industry and FDA speakers will focus on decentralized clinical trial pitfalls, FDA inspection preparation, KRIs, KPIs, and QTLs, remote auditing, and changes in ICH E6. Please join us for an informative, interactive and fun day with plenty of time for questions and interaction with the speakers and your QA colleagues.
 
Objectives
At the end of this course, the participant shall be able to:
  • Identify at least 2 things FDA Recommends in preparing for FDA Inspections
  • Discuss Key Rick indicators, Key Performance Indicators and Quality Tolerance Limits and their inter-relationships
  • List three tips for auditing Decentralized Trials
  • Describe challenges in conducting Sponsor audits of CROs
  • List at least two key concepts for remote auditing to ensure data integrity or Part 11 compliance
  • Explain at least 1 change I the ICH E6(R3) Good Clinical Practice DRAFT Guideline
Target Audience
GCP Auditors with 3 or more years of experience
 
Agenda
  • Dr. Chrissy Cochran, US FDA: FDA Inspection Preparation Tips
  • Pam Giltner: Decentralized Trials, Regulation and Auditing Tips
  • Lee Truax-Bellows: Key Risk Indicators (KRI), Key Performance Indicators (KPI) and Quality Tolerance Limits (QTL)
  • Angela Bazigos: covers the topics of Sponsor Audits of CROs and Remote Auditing for 21 CFR Part 11 / Data Integrity: The New Virtual World of Remote Audits and Inspections
  • Glenda Guest: will look back at key changes to ICH E6(R2) and take a look ahead at the pending ICH E6(R3) Draft
 

7 — GEN 210: Using Situational Leadership to Manage Yourself and Your Team (Half-day, In person)

Tuesday, 20 September 2022, 8:00 AM-12:00 PM

Registration Rates

  • By 29 August 2022:  Member $310,  Non-member $410,  University Members $225,  Student/Outreach Members $145
  • After 29 August 2022:  Member $370,  Non-member $470,  University Members $285,  Student/Outreach Members $145
        Register Online
 
 RQAP re-registration units: 4.00 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.

Presenters
Jackie Torfin, QRx Partners

Description
Learn about the Situational Leadership Model, a model created by Paul Hersey and Ken Blanchard. The fundamental principle of the model is that there is no single "best" style of leadership. Effective leadership is task-relevant, and the most successful leaders are those who adapt their leadership style to the performance readiness (ability and willingness) of the individual or group they are attempting to lead or influence. Effective leadership varies, not only with the person or group that is being influenced, also depending on the task, job, or function that needs to be accomplished. Bring your most difficult examples and let's work on them! 

Objectives
At the end of this course, the participant shall be able to:
  • Apply the Situational Leadership model in how they manage people that they work with in either a functional management or project management role
  • Understand their go-to leadership style
  • Modify their leadership style to the best style for each circumstance or person
 

Target Audience
Any professional who is in a functional or persuasional leadership role.  

Agenda
  1. What is the Situational Leadership Model?
  2. What is your preferred leadership style?
  3. Case study examples on different applications of the model
  4. Application of the model to individual cases with feedback

     

     

8 — GLP 105: Introduction to FDA GLP Bioresearch Monitoring Compliance Program (One-day, In person only)

Wednesday, 21 September 2022, 8:00 AM-5:00 PM EDT

Registration Rates
  • By 29 August 2022:  Member $495,  Non-member $615,  University Members $375,  Student/Outreach Members $255
  • After 29 August 2022:  Member $545,  Non-member $665,  University Members $425,  Student/Outreach Members $255
        Register Online
 
RQAP re-registration units: 8.00 GLP or non-GCP*
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters
Eric Pittman, US FDA; Barb Munch, Munch GLP Consulting; Lori Wright RQAP-GLP, StageBio

Description
This class will review the FDA Compliance Program for Bioresearch Monitoring of the Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) regulations (7348.808). FDA implemented this program of regular inspections and data audits to monitor laboratory compliance with the GLP regulations. The Compliance Program directs the FDA Investigators how to conduct their GLP inspections of firms.

Objectives
At the end of this course, the participant shall be able to:
  • Describe how the FDA uses the Compliance Program to perform inspections
  • Apply the GLP Compliance Program information to build compliant processes
  • Manage an FDA Inspection and respond to a 483
  • Identify what records to provide FDA Investigators during an inspection
  • Interpret selected warning letter findings based on understanding the Compliance Program and GLP regulations

Target Audience
FDA GLP QA Auditors and Managers, from beginners to experienced, as well as Study Directors, Principal Investigators, and Testing Facility Management

Agenda
  • The FDA GLP Compliance Program
  • Compliance Program Content
  • Managing an Inspection and Responses
  • Remote Regulatory Assessments to On-site Inspections
  • Other Useful FDA Documents
  • Changes between Compliance Program versions
  • Inspection Real Life Examples & Lessons Learned and Discussion Topics

9 — GCP 301: Advanced Training (One-day, In person)

Wednesday, 21 September 2022, 8:00 AM-5:00 PM
 
Registration Rates
  • By 29 August 2022:  Member $495,  Non-member $615,  University Members $375,  Student/Outreach Members $255
  • After 29 August 2022:  Member $545,  Non-member $665,  University Members $425,  Student/Outreach Members $255
        Register Online
 
RQAP re-registration units: 8.00 GCP or non-GLP*
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters
Lee Truax-Bellows RQAP-GCP, NCRA; Glenda Guest RQAP-GCP, Assured of Quality Consulting & Training; Pam Dellea-Giltner RQAP-GCP, PDG Clinical Consulting; Chrissy Cochran PhD, US FDA

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 this course, the participant shall be able to:
  • Incorporate presented professional development and advanced audit and training techniques into their role
  • Incorporate current regulations and guidelines that impact GCP into their role
  • Implement a quality management system approach in their role

Target Audience
GCP Auditors with at least 3 years' experience

Agenda
  • GCP Quality Management Systems from a Regulator Perspective
  • GCP Quality Management System (QMS) CAPAs from a Sponsor Perspective
  • GCP QMS from an Auditing Perspective
  • Auditing a Trial Master File

 

10 — GMP 201: Effective GMPs (One-day, In person)

Wednesday, 21 September 2022, 8:00 AM-5:00 PM 

Registration Rates
  • By 29 August 2022:  Member $495,  Non-member $615,  University Members $375,  Student/Outreach Members $255
  • After 29 August 2022:  Member $545,  Non-member $665,  University Members $425,  Student/Outreach Members $255
        Register Online
 
RQAP re-registration units: 8.00 non-GLP or non-GCP*
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters
Judy Carmody PhD, Carmody Quality Solutions; Ed Armstrong, Mustang Bio

Description
This 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 this course, the participant shall be able to:
  • Summarize the foundations of GMP quality and compliance
  • Identify what to establish for in-house operations
  • Identify what to look for when outsourcing
  • Describe how to maintain compliance
  • Explain how to host an inspection
  • Describe risk-based approaches to GMPs
  • Explain how to access knowledge 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 the industry.

Agenda
  • Rationale behind GMPs
  • Quality Systems: Complaints, QRM CAPA, Out-of-Specifications/Trend, Supplier Qualification, AQR
  • Manufacturing Technologies: Biologics Upstream/Downstream and Aseptic Fill, Aseptic Monitoring
  • Laboratory Techniques: HPLC, GC, MSD, UPLC, micro, stability
  • Quality Engineering: Facilities Utilities Equipment
  • Qualification, Preventive Maintenance and Metrology
  • Supplier Oversight
  • Part 11 - Electronic Records / ElectronicSignatures
  • Computer Software Validation
  • Data Integrity
  • Laboratory Instrumentation and Manufacturing Equipment Validation
  • Compendia Method Verification
  • Inspection Prep / Management
  • Hosting U.S Inspections
  • Responding to Observations
  • Specialty Topic: Combination Products
 

11 — GLP 104: Auditing Techniques (Virtual Only)

Monday and Tuesday, 26 and 27 September 2022, 10:00 AM-2:30 PM EDT each day
 
Registration Rates
  • By 29 August 2022:  Member $445,  Non-member $565,  University Members $325,  Student/Outreach Members $225
  • After 29 August 2022:  Member $475,  Non-member $605,  University Members $350,  Student/Outreach Members $225
        Register Online
 
RQAP re-registration units: 8.00 GLP or non-GCP*
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Presenters
Gina Tucker RQAP-GLP, JAF Consulting; Sara Rybak RQAP-GLP, Charles River
 
Description
This course is a comprehensive introduction to auditing GLP study data, final reports and facility records, utilizing data and examples from mock in-vitro and in-vivo studies. 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 this course, the participant shall be able to:
  • Summarize the regulatory requirements for FDA GLP QA, including high-level EPA/OCED GLP differences
  • Explain 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 protocols, 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
  • Apply 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
  • Quality Assurance Responsibilities
  • CPGM Overview
  • Protocol Audits
  • Process and Phase Inspections
  • Facility Records
  • Remote Auditing
  • Electronic Records
  • Study Data (including electronic data, and audit trails)
  • Report Audit
  • Writing and Resolving Audit Reports
  • Quality Assurance Statements
 

12 — DEV 202: ISO 17025 Standard on Testing and Calibration Laboratories and Its Application to Medical Device, Pharmaceutical, and GLP Testing (Virtual Only)

Wednesday, 28 September 2022, 10:00 AM-2:30 PM EDT
  
Registration Rates
  • By 29 August 2022:  Member $275,  Non-member $355,  University Members $205,  Student/Outreach Members $135
  • After 29 August 2022:  Member $295,  Non-member $380,  University Members $220,  Student/Outreach Members $135
        Register Online
 
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.

Presenters
Jackie Torfin, QRx Partners
 
Description
This course will provide attendees with a good understanding of the ISO 17025:2017 standard, its compliance framework, and its application and importance in testing and calibration. Through the use of case studies, we will interactively determine nonconformities to the standard and assess, using risk-based thinking, actions to be taken to resolve the issues. 

Objectives
At the end of this course participants will be able to:
  • Interpret the ISO 17025:2017 standard and its application in testing and calibration laboratories
  • Determine the nonconformities of case study situations
Target Audience
Anyone who works with calibration or testing laboratories - either medical device or pharmaceutical - and wants a better understanding of accreditation to ISO 17025.
 
Agenda
  1. ISO 17025 standard review, including risk-based QMS design
  2. The use of ISO 17025 in a GLP testing setting
  3. How ISO 17025 laboratory accreditation relates to the FDA Accreditation Scheme for Conformity Assessment (ASCA) program for medical devices
  4. Case Study review, nonconformance determinations and remedial actions