September 2015 Quality College Course Descriptions




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

8:00 AM 28 September 2015 – 5:00 PM 29 September 2015

RQAP re-registration units: 4.00 GLP

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

Prices

  • Before 24 August 2015: Member Rate $745, Non-member Rate $895
  • After 24 August 2015: Member Rate $805, Non-member Rate $955

Description
This course is a comprehensive introduction to FDA Good Laboratory Practice regulations or refresher training for all personnel involved in a nonclinical laboratory study. The course also provides a review of GLP history, examination of the FDA Preambles, offers topical comparisons between FDA and EPA requirements and OECD principles, and is intended to equip the participant with a working knowledge of GLP impacts on study conduct. Opportunities for group interaction and breakout periods help widen the educational exchange while enhancing the learning process. 

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

 

  • Understand the regulatory requirements for nonclinical laboratory facilities, equipment, personnel, methods, practices, records and controls to assure Management of compliance or report the lack thereof
  • Identify compliance gaps in the overall quality system of a facility and suggest improvements based upon regulatory requirements
  • Effectively communicate the requirements of FDA GLPs and identify topical differences between FDA and EPA requirements and OECD Principles of GLP
  • Interpret and apply GLP requirements using a variety of resources
  • Use the knowledge obtained by completing the training exercises to increase effectiveness in current role


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


Agenda

 

Day 1 Agenda:

  • Training Overview - Logistics, Agenda, Approach, Class demographics, Question Development
  • History of the GLPs
  • Organization of GLPs
  • Scope
  • Definitions
  • Applicability to studies performed under grants and contracts
  • Inspection of a testing facility
  • Personnel
  • Testing Facility Management
  • Study Director
  • Practical Exercise
  • Quality Assurance Unit
  • General
  • Animal care facilities
  • Animal supply facilities
  • Facilities for handling test and control articles
  • Laboratory operation areas
  • Specimen and data storage facilities
  • Equipment design
  • Maintenance and calibration of equipment
  • Standard operating procedures

Day 2 Agenda:

  • Reagents and solutions
  • Animal care
  • Test and control article characterization
  • Test and control article handling
  • Mixture of articles with carriers
  • Protocol
  • Conduct of a nonclinical laboratory study
  • Reporting of nonclinical laboratory study results
  • Storage and retrieval of records and data
  • Retention of records
  • Reporting of nonclinical laboratory study results
  • Storage and retrieval of records and data
  • Retention of records
  • 21 CFR Part 11
  • Shall versus Should
  • OECD Differences
  • Final Q&A

* Practical Exercises will be interspersed in-between presentations


2 — Good Clinical Practice: The Basics (1 Day)

8:00 AM - 5:00 PM 28 September 2015

RQAP re-registration units: 2.00 GCP

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

Nursing CEUs: This provider (Society of Quality Assurance) is approved by the California Board of Registered Nursing, Provider Number 13498, for 7.5 contact hours for this course.

Prices

  • Before 24 August 2015: Member Rate $410, Non-member Rate $560
  • After 24 August 2015: Member Rate $470, Non-member Rate $620

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

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

 

  • Define Good Clinical Practices
  • Cite key events impacting the evolution of GCP
  • Find key regulations within 21 Code of Federal Regulations
  • Describe 3-4 activities- Define Good Clinical Practices
  • Cite key events impacting the evolution of GCP
  • Find key regulations within 21 Code of Federal Regulations
  • Describe 3-4 activities to be performed during an audit to be performed during an audit


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


Agenda
  • Welcome: housekeeping, agenda review, and introductions
  • History of GCP
  • Basic Principles and Standards
  • Clinical Trial Stakeholders – Roles/Responsibilities
  • Life Cycle of a Clinical Trial & Essential Documents
  • The Informed Consent Process
  • Investigational Product
  • Research Subject Safety
  • GCP & Clinical Investigator Audits
  • Wrap Up


3 — Data Quality/Data Integrity: Can You Trust the State of Your Data (1/2 Day)

8:00 AM - 12:00 PM 28 September 2015

RQAP re-registration units: TBD 

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

Prices

  • Before 24 August 2015: Member Rate $285, Non-member Rate $385
  • After 24 August 2015: Member Rate $345, Non-member Rate $445

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

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

 

  • Define the terms Data Quality vs. Data Integrity
  • Identify what can impact Data Quality/Data Integrity
  • Describe different methods for evaluating Data Quality/Data Integrity
  • Discuss the consequences of poor Data Quality/Data Integrity


Target Audience
GxP Professionals with an interest in broadening their perspective on Data Quality/Data Integrity concepts. 


Agenda
  • Data Quality/Data Integrity Lexicon
  • Data Quality/Data Integrity - Concepts to Consider
  • Importance of Quality of Source Data
  • Small Data vs. Big Data
  • Hypothesis vs. Data Mining
  • Using Trends
  • Hard Copy vs. Electronic Data
  • Standards
  • Impact of Cloud Computing Infrastructure
  • Use of Open Source Tools/Data
  • Use of COTS/Internally Developed Systems
  • Stakeholders
  • How to assess Data Quality/Data Integrity when performing an audit
  • Impact of Issues with DQ/DI


4 — GCP & Data Stewardship: Avoiding Extinction by Crossing the IT Boundary (1/2 Day)

1:00 - 5:00 PM 28 September 2015

RQAP re-registration units: 1.00 GCP

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

Prices

  • Before 24 August 2015: Member Rate $285, Non-member Rate $385
  • After 24 August 2015: Member Rate $345, Non-member Rate $445

Description
Even established GCP professionals can feel at a disadvantage when facing the regulatory challenges that arise with new digital technologies and electronic data. Data Stewardship is an approach that allows established GCP principles to be applied with confidence in the fast changing world of tablet devices, evolving EDC systems, and eSource. Master the application of GCP-ICH in the operational world of computerized systems used in the conduct of clinical trials--knowing what to do after the validation has been signed. 

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

 

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


Target Audience
QA professionals who oversee general GCP-ICH compliance for clinical trials; QA professionals who prepare and support clinical trial teams for health authority inspections; QA professionals in "eCompliance" roles. 


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


5 — GCP Hot Topics: Audit Management (1 Day)

8:00 AM - 5:00 PM 29 September 2015

RQAP re-registration units: 2.00 GCP 

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

Prices

  • Before 24 August 2015: Member Rate $510, Non-member Rate $660
  • After 24 August 2015: Member Rate $570, Non-member Rate $720

Description
TBD. 

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

 

  • TBD


Target Audience
GCP QA Professionals with an interest in Audit Management. 


Agenda
  • Welcome: housekeeping, agenda review, and introductions
  • Audit Basics
  • Preparing for a Clinical Investigator/Vendor Audit
  • Performing the Audit
  • Audit Reports
  • Mock Audit
  • Present your Findings!
  • Audit Q&A
  • Hosting an Audit/Inspection
  • Managing Audit Outcomes (CAPAs)
  • Wrap Up


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

8:00 AM - 5:00 PM 29 September 2015

RQAP re-registration units: 2.00 Non-GCP, Non-GLP 

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

Prices

  • Before 24 August 2015: Member Rate $510, Non-member Rate $660
  • After 24 August 2015: Member Rate $570, Non-member Rate $720

Description
Fundamental to an effective CAPA program is the practical application of Root Cause Analysis (RCA) and developing an understanding of the root cause(s), contributing cause(s), and possible cause(s) of the issue/problem. Defining the problem – setting boundaries – is integral to enabling an effective RCA. This course will provide tools, insight and best practice to support continuous process improvement and enable sustained results by emphasizing approaches to defining the problem and analyzing the causal factors. A common deficiency in many Industry CAPA programs is a myopic RCA identifying human error and solely prescribing training as the preventive mitigation. By going beyond human error and training, the effective CAPA program becomes a systematic assessment, focusing less on the individual and more on the process(es) in place (What about the process that allowed the issue to occur?) and the process quality control (What about the process that allowed the issue not to be detected?).  

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

 

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


Target Audience
Basic to intermediate. 


Agenda
  • 8:30 – 9:30 Process Improvement Fundamentals
  • 9:30 – 10:00 Data Driven Decision Making
  • 10:00 - 10:15 Break
  • 10:15 - 11:00 Data Driven Decision Making
  • 11:00 – 12:00 Group practice and report out (data to trend)
  • 12:00 – 1:00 Lunch
  • 1:00 – 3:00 Root Cause Analysis
  • 3:00 – 3:15 Break
  • 3:15 – 4:15 Group practice and report out – scenario
  • 4:15 – 5:00 Additional Information – Q&A


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

8:00 AM - 12:00 PM 29 September 2015

RQAP re-registration units: 1.00 GLP

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

Prices

  • Before 24 August 2015: Member Rate $285, Non-member Rate $385
  • After 24 August 2015: Member Rate $345, Non-member Rate $445

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

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

 

  • Learn the history behind the FDA GLP regulations
  • Learn the correlation between the initial fraud, regulations, and CPGM
  • Learn how to apply the GLPs to situations at their local labs
  • Understand how to apply history learnings to write better findings


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


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


8 — SEND: Implementation and Validation (1/2 Day)

1:00 - 5:00 PM 29 September 2015

RQAP re-registration units: 1.00 Non-GCP, Non-GLP 

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

Prices

  • Before 24 August 2015: Member Rate $285, Non-member Rate $385
  • After 24 August 2015: Member Rate $345, Non-member Rate $445

Description
The deadline for implementation of the FDA SEND initiative is a little over a year away and many are feeling the pressure to implement and validate a SEND solution. This course will cover the process flow for harmonization, implementation and validation of a SEND solution, including the regulatory requirements covering a SEND compliant submission and potential pitfalls that may be encountered along the way. Emphasis will be placed on points to consider when meeting the expectations of SEND and workshops will allow for open discussion of issues brought forward by attendees. 

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

 

  • Define the regulatory requirements covering a SEND submission
  • List the elements of a compliant SEND submission
  • Identify potential pitfalls in the implementation of a SEND solution
  • Access the tools available for validation of a SEND solution


Target Audience
Any individual who is embarking on the process of implementing and validating a SEND solution. 


Agenda
  • Introduction: Data processing and data integrity
  • Current status: Study types included; Deadlines for implementation
  • Regulatory expectations
  • What is a SEND compliant submission?: Required data sets; Standard terminology; Define file
  • Harmonization: Activities required to prepare for implementation of SEND; Data systems (electronic, paper-based, etc.)
  • Validation: Responsibilities; Points to Consider
  • Potential pitfalls: Risk Management; Legacy Systems; Resource commitment
  • Summary


9 — GxP Inspection Readiness (1 Day)

8:00 AM - 5:00 PM 30 September 2015

RQAP re-registration units: 2.00 GCP or GLP 

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

Description
This session is devoted to general inspection readiness activities that would apply across GXP disciplines as well as specific topics relevant to the different GXP disciplines or varying regulatory agency expectations. Examples of regulatory inspection trends will be highlighted and corrective action and responses to regulatory agency inspectional findings will also be included. 

Prices

  • Before 24 August 2015: Member Rate $510, Non-member Rate $660
  • After 24 August 2015: Member Rate $570, Non-member Rate $720

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

 

  • Understand inspection readiness and the inspection process
  • Apply inspection readiness principles to their own organization
  • Identify gaps and better manage regulatory agency inspection


Target Audience
Personnel (auditors, subject matter experts) who participate in regulatory agency inspections- either in inspection readiness activities or inspection conduct. 


Agenda
  • General inspection readiness: pre-inspection preparation
  • Inspection readiness toolbox- tools and templates are being used
  • Inspection teams, roles and responsibilities
  • Conduct of the inspection, possibly role playing scenarios, dos and don’ts
  • Different regulatory agencies and their expectations
  • Specific inspections, lessons learned- depending on the audience, could break out by discipline: e.g.,GCP/GLP/GMP inspections; possibly BE and PV inspections
  • CAPA, responses to regulatory agencies
  • Recent inspection trends


10 — Business Continuity & Disaster Recovery (1/2 Day)

8:00 AM - 12:00 PM 30 September 2015

RQAP re-registration units: 1.00 GCP or GLP 

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

Prices

  • Before 24 August 2015: Member Rate $285, Non-member Rate $385
  • After 24 August 2015: Member Rate $345, Non-member Rate $445

Description
By the end of this training, you will have the essential and practical knowledge and tools for creating and effective, comprehensive, and reliable Business Continuity and Disaster Recovery Plans for your organization. The session will also discuss the auditing techniques for the quality professional to effectively audit the plans as well as suppliers to the process. The session teaches you how to develop Business Continuity and IT Disaster Recovery Plans which comply with the industry`s best practices and standards. Participants will have hands-on exercises performing table top scenarios that will help them leverage their learnings. 

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

 

  • Establish BC Program lifecycle processes within your organization
  • Assess business and technology requirements for a BC Plan
  • Evaluate Business Continuity risks to your organization
  • Identify and select cost-effective BC recovery strategies
  • Organize an effective BC team
  • Develop a BC Plan document
  • Coordinate a BC Plan with external entities
  • Develop an effective test plan for testing the BC Plan
  • Organize and conduct successful BC Plan tests
  • Establish a process for maintaining the BC Plan
  • Implement a BC Plan change management process
  • Avoid typical mistakes that lead to BC Program failures
  • Understand the main differences between a Disaster Recovery Plan, Emergency Response Plan, Crisis Management Plan, and Business Continuity Plan


Target Audience
This training is ideal for personnel that: Are new to the concept of disaster recovery (DR) and business continuity (BC)and need to develop a DR and/or BC Plan; Need to validate or improve an existing BC Plan for your organization; Have been assigned to lead or be a part of a Business Continuity Program team for your organization; Are responsible for preparing a DR Plan for your IT systems, network infrastructure and data centers; Plan to offer professional consulting services for BC and DR; Need to ensure your BC Plan meets the requirement for internal or external audits; Need to expand your current area of expertise to BC.
The training is especially useful for Business Continuity and Disaster Recovery Planners, Business Unit Managers, Project Managers, Quality Assurance, Senior Management, and staff from Information Technology, Security, Emergency Response and Crisis Management, Communications, Facilities, Operations Management and Human Resource Departments. 


Agenda
  • Define Business Continuity & Disaster Recovery
  • Define Phases of Business Continuity
  • Develop a governing process including Quality Assurance oversight
  • Provide Lessons Learned


11 — Electronic Archiving & Digital Decay (1/2 Day)

1:00 - 12:00 PM 30 September 2015

RQAP re-registration units: 1.00 GCP or GLP 

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

Prices

  • Before 24 August 2015: Member Rate $285, Non-member Rate $385
  • After 24 August 2015: Member Rate $345, Non-member Rate $445

Description
Archiving has gained attention recently as more diverse data types are being generated by scientists and more 483s are issued by the regulatory agencies. The course is of special value to personnel who already have the foundations of computer validation, 21 CFR Part 11 & GxP regulations and are seeking experience with advanced compliance concerns with the archiving of electronic data in a regulated environment. The course is especially designed for attendees seeking a deeper understanding of electronic data and ways to maintain the integrity of the data. This course answers the question of who, what, when, where, why, & how of electronic archiving and associated processes. 

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

 

  • Understand Electronic Data and the ways in which it is preserved and archived
  • More will be developed


Target Audience
This course is designed for Validation, Quality, IT, and Business personnel responsible for managing electronic archives in the Life Science and Medical Device industries with over 5 years of experience in data archiving or systems implementation. 


Agenda
  • The Problem
  • Regulation and Guidance
  • The Solution?
  • Current Approaches


12 — CAPA: Creation and Effectiveness: Beyond Training (Across GxPs) (1 Day)

8:00 AM - 12:00 PM 30 September 2015

RQAP re-registration units: 2.00 Non-GCP, Non-GLP 

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

Prices

  • Before 24 August 2015: Member Rate $510, Non-member Rate $660
  • After 24 August 2015: Member Rate $570, Non-member Rate $720

Description
An effective CAPA process begins with Root Cause Analysis and ends with CAPA Effectiveness. The process requires strategic direction, risk assessment, effective communication, accountability and responsibility agreed and clearly defined. This course will take a deep dive into the CAPA Process; the purpose, effective CAPA creation and how to use the information for fundamental organization change. 

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

 

  • Understand the value of an organization CAPA Process
  • Move from Root Cause identified to corrective and preventative action by
  • Developing a CAPA that addresses the Root Cause (case studies to be provided for hands-on)
  • Ensure CAPA is valid and validated
  • Effectiveness checking of CAPA via internal audit review
  • Systematically implement global CAPA process


Target Audience
Intermediate to advanced; attendees should complete the CAPA Day 1 course. 


Agenda
  • 8:00 - 10:00 AM: Review of Problem Definition and Root Cause Analysis; Group Refresher Root Cause Analysis
  • 10:00 – 10:15 AM: Break
  • 10:15 AM – 12:00 PM: The Purpose of a CAPA; How to Facilitate CAPA Effectiveness; Group Practice (CAPA Steps 5-6)
  • 12:00 – 1:00 PM: Lunch Break
  • 1:00 –3:00 PM: Group Practice and Report; Fundamental Change through Trend Analysis and Process Improvement
  • 3:00 – 3:15 PM: Break
  • 3:15 – 5:00 PM: CAPA Systems; Group Scenario – CAPA Systems and Communication; Q&A


13 — The Biologics Super Highway: An Auditor's On-Ramp (1/2 Day)

8:00 AM - 12:00 PM 30 September 2015

RQAP re-registration units: TBD 

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

Prices

  • Before 24 August 2015: Member Rate $285, Non-member Rate $385
  • After 24 August 2015: Member Rate $345, Non-member Rate $445

Description
This course is intended to provide an overview of the science that goes into the analysis of biologics for regulated studies. We will discuss traditional methods of bioanalysis, as well as where the technology is headed. There will be comparisons along the way with small molecule analysis, along with where the technologies are overlapping today. Finally, we will discuss the differences between bioequivalency, bio-comparability and biosimilars. 

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

 

  • Describe different technologies used in bioanalysis for biologics
  • Diagram an ELISA method
  • Identify key statistics within LIMS data which are critical during a data audit
  • Compare and contrast the terms bioequivalence, bio-comparability and biosimilar


Target Audience
Quality professionals, especially those responsible for auditing analytical and bioanalytical analyses, data and reports, interested in learning the basics of the science behind TK/PK sample analysis, particularly as it relates to biologics, regulated bioanalysis and biosimilars. 


Agenda
  • Assay Formats for Biologics
  • The Nuts & Bolts of an ELISA Assay
  • The Nuts & Bolts of an MSD Assay
  • Gyros
  • Multiplex
  • ADCs
  • Large Molecule Analysis by LC/MS
  • LB-LCMS (Hybrid Analysis)
  • Immunogenicity
  • Data Review for Small and Large Molecules
  • BE, Biocomp, Biosimilars
  • (TBD)


14 — Fraud & Misconduct in PV & GMP (1/2 Day)

1:00 - 12:00 PM 30 September 2015

RQAP re-registration units: 1.00 Non-GCP, Non-GLP

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

Prices

  • Before 24 August 2015: Member Rate $285, Non-member Rate $385
  • After 24 August 2015: Member Rate $345, Non-member Rate $445

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

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

 

  • Know what was Novartis Japan's PV incompliance
  • Know what was Rambaxy India's GMP Fraud
  • Recognize what is the cause for these misconduct and fraud
  • Understand the importance of (global) quality assurance audit


Target Audience
PV auditors and GMP auditors with 2 or more years of experience 


Agenda
  • What happened in Novartis Japan's PV Department?
  • What happened in Rambaxy India's Toansa Factory?
  • Analysis of PV incompliance in Novartis Japan's PV
  • Analysis of fraud in Rambaxy India's Toansa Factory
  • Regulatory action (MHLW & FDA)
  • Did QA perform good job?
  • What is the problem with corporate governance?
  • Corrective & preventive action