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Create a new spreadsheet and edit with others at the same time -- from your computer, phone or tablet. Get stuff done with or without an internet connection. Use Sheets to edit Excel files. Free from Google.

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in list Your Training Plan

Description:

Here's a selection of a few things that we recommend you continue with throughout your first month.

As always, feel free to add, edit and remove as you see fit. This is your board to use as you chose.

Actions:

- Check your monthly master board for any card updates: Copying cards on trello Archiving cards

- Check for any new Cornerstone training to complete

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in list Personalised Health Care

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in list Quality Briefs

Description:

Narrative: - A summary of the Quality of a Molecule, Product, Affiliate or Process using the Impact Factor framework substantiated by the evidence coming out of audits conducted to answer objective questions and providing a definitive conclusion on the Quality position of the entity described in the narrative. The purpose of a narrative is to provide assurance to HAs on the quality of Roche molecules / products / processes and affiliates to accelerate approvals for patients.

Please note Narratives have been rename to QBD (see QDB (narrative) card below)

Review the information and links on the cards in this list to learn more about QBDs for QAx.

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in list Data Mastery

Description:

Data mastery is key to enabling greater insight and achieving the PD 2030 vison of 2-3 times more at 50% less.

Analytics: - Analytics (in the context of Audit) is a tool (not an activity) to visualise data during audits to enable better / quicker decision-making and conclusions to be made when answering objective questions. (Analytics may also be used to support other PDQ work eg Risk Assessment / QMS etc or be conducted as part of 1st line of control used by embedded Quality groups)

Review the information and links on the cards in this list to learn more about Data Mastery for QAx.

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in list Audit (Evidence Generation)

An audit is any activity that sets out to answer an objective question for the purpose of generating evidence to support a quality position to include in a narrative. All audits are visible to Portfolio Planning and documented in QUEST & PSMF

Audit is no longer a tool deployed purely to reactively detect issues for fixing.

Review the information and links on the cards in this list to learn more about Audits for QAx.

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in list Connect

- The following people and forums are available when you need help:

Your Manager: Your manager helps foster connections with others and provides ongoing updates on the broader strategy to aide in your own development.

Communities of Practice and Forums: See cards below

PDQ Connect: Important announcements about PDQ are posted here

Trello questions: If you have any technical questions as you use this Trello board, please reach out to Maureen Prather (mcmurphy@gene.com)

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in list Risk Assessment

PDQ uses a risk-based approached based on a defined set of Impact Factors is used across internal processes, service providers, affiliates, license partners, and computerized systems, as well as product-specific and molecule specific strategies.

Applying risk assessment is key to how we work.

Review the information and links on the cards in this list to learn more about Risk Assessment for QAx.

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in list Key Training

A selection of Key Trainings and information has been provided below to onboarding you toy QAx. This is not intended to be exhaustive but give you a foundational start of key areas.

Review the information and links on the cards in this list to learn more about Key Trainings and Access for QAx.

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in list PDQ_QAx Systems & Tools

There are a number of systems and tools used regularly by the QAx Sub-functions. It is a good idea to familiarize yourself with the purpose of these tools by clicking on the links to learn more. You may use some more than others and many require training to access.

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- Trello Quick Overview
- Cornerstone Training on Trello
- Trello Youtube Channel
- How to use Trello like a pro
- Trello cheat sheet
- You can download the trello app for iOS
- Trello Help
- Our in-house training on the cSuite Academy

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in list PDQ_QAx Systems & Tools

This site provides information, tools, training, and resources for all QLs. It serves as the single point of reference.

- QAx Information hub

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in list Key Training

The Quality Management System (QMS) as it relates to GCP, GVP and Medical Devices and how it is applied across Roche, with various groups accountable for the QMS.

- GOV-0100040

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in list Your Training Plan

Description:

Meet with your manager to:
1) Formulate your objectives
2) Identify your training needs (using the Capability Assessment Tool)
3) Create your personal training plan using the template

- Capability Assessment Tool

- QAx Training Plan

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in list Quality Briefs

Description:

The Quality Briefs:
This articulates ownership & content (Quality), intent & purpose (Briefing)

- Review QD toolkits

- Attend the QB Capability Training series

- Review existing QBs to gain exposure

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If you have not done so already please be sure to review the PDA Onboarding Trello first. If you have not received the PDQ onboarding email (which including the Trelloboard), please contact Karl Sutphin sutphin.karl@gene.com

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in list Data Mastery

- PDQ Data Analytics Onboarding Short overview of Data Analytics and Resources

- PDQ Data Analytics. Information and resources relating to Data Analytics, Data Packages and training information.

- Current set of dashboards available

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in list Personalised Health Care

Description:

The goal is that through these resources below, that you can build your foundational awareness of various topics including PHC, Next Molecular Sequencing, Digital Health, Artificial Intelligence, Real World Data and Regulations regarding Medical Devices.

- Fundamentals of Integrated Healthcare Solutions for PDQ - Cornerstone Playlist

- Integrated Healthcare gSite for Guidances and Podcasts

- Essentials to Clinical Quality for Next-Generation Sequencing- part 1

- Essentials to Clinical Quality for Next-Generation Sequencing- part 2

- Integrated Healthcare Solutions gSite

- PHC Quality Uncovered - Podcast Series

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Objectives for your PDQ Onboarding Experience

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Objectives for your PDQ Onboarding Experience

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Welcome to PDQ-QAx!

QAx covers:

Quality Assurance Affiliate

Quality Assurance Programs

Quality Assurance Process

Quality Analytics & Insight

Quality Platform & Proficiency

Below are our learning objectives for our Onboarding experience. We hope that as you move through your Trello board the objectives are achieved and this enables you to thrive & add value towards achieving your individual and our company ambitions.

Objective1: Increase your knowledge of QAx and how the sub-functions works so you understand how you add value

Objective 2: Increase and build your core knowledge and skills so you can focus of delivering outcomes.

Objective 3: Increase your networking to improve your opportunities to forge relationships

If at any point you want to discuss these objectives please reach out to your Manager, Team or other assigned resources (e.g. Mentor, coach, trainer etc). Ongoing check-in's across your onboarding experience will help you to see how you're progressing.

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As you begin your QAx onboarding experience, take a minute to watch the following video from Jonathan Taylor welcoming you to PDQ (if not already done as part of the PDQ onboarding) and read the welcomes from the QAx Heads

- Welcome video from Jonathan Taylor
- Welcome message from Michael Torok (Programs)
- Welcome message from Dan Dodwell (Process)
- Welcome message from Charles Li (Affiliate)
- Welcome message from Roshan D'Souza (Quality Analytics & Insights)
- Welcome message from Timothe Menard (Quality Data Science)
- Welcome message from Alison Knox (Platform & Proficiency)

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in list Risk Assessment

Description:
What are Impact Factors:
Impact Factors are focus areas of activities presenting greatest risk or opportunity. Each Impact Factor has a target Quality Position and may have sub-positions. Impact Factors from the foundation of the Quality Strategy and drive the narratives across Process, Programs and Affiliate

How are they used:
A risk-based approached based on a defined set of Impact Factors is used across internal processes, service providers, affiliates, license partners, and computerized systems, as well as product-specific and molecule specific strategies. There are 15 impact factors in total.

Each of the impact factors has a Quality Position, which is representative of an ideal state of quality. The quality position can be delineated by a series of sub-impact factors/positions, which further describe and contribute to the ideal state of quality for the impact factor.

Assessment of the impact factors includes a review of the quality assurance evidence, generated through audit activities, against the Quality Position/sub-positions.

Link to Review:

- Additional information is available in the following Guidance Documents: BI-0300049

- Impact Factors, Quality Positions, Sub-Impact Factors and Sub-Quality Positions listing can be found here. Also see the QPL card for QPL specific Impact Factor tools

- Report 126 shows Positive Evidence and Findings by Impact Factor

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Review the information via the links below to learn more about PDQ including, our mission, our leadership and how we're organized.

- PDQ Quality Narrative
- Meet the PDQ Leadership Team
- PDQ Departments
- Analytics & Insights
- Affiliate Assurance
- Quality Assurance Process
- Quality Assurance Programs
- Quality Assurance Platform & Proficiency

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- PDQ's Quality Narrative: Our transformation and vision guidance that will take us along our journey to reach our 2030 Pharma Vision.

- Quality Manual: This training should have been assigned to you in Cornerstone. This procedure outlines the importance of the Quality Management System (QMS) for GCP, GVP and Medical Device processes. PDQ oversees this process and ensures the system is applied throughout the organization.

- Outcomes: Outcomes are focusing our attention on impact and value outcomes-based planning. As QAx, our culture and language defines the system - to accelerate, the system needs to enable our strategy (based on the PD 2023 vision and defined in the PDQ Narrative) by aligning our QAx Strategy, Language, outcomes and how we operationalise and accelerate.

- Impact Factors: Focus areas (15) based on activities presenting greatest risk or opportunity. Each Impact Factor has a target Quality Position (QP) and may have sub-positions. Additional information is available in the following Guidance Document: BI-0300049.

Add an item

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For a full list of across PDQ System and tools please link to the PDQ Onboarding Trello Card (PDQ Systems and Tools)

- PDQ Systems and Tools

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in list Key Training

Auditors are not required to training on all SOPs before auditing the topic area (e.g. ICSR SOP, ICF SOP etc).

SOPs that are mandatory include the Audit and CSFM SOPs.

- Global: Clinical and Safety Finding Management (SOP-0105265) [Note: Included in QUEST Training]

- Global: Quality Assurance Audits (SOP-0105363) [Note: Included in QUEST Training]

- SOP-0107273, Global: Serious GCP Non-Compliance or Misconduct

- SOP-0120965: Global: Quality Assessment for Incoming Partnered Assets

- Phoenix Portal An in house developed system to enable migration from condor in waves (i.e., to mitigate the impact of migrating everything from condor at the same time) and to enable some features for the end user which are not native yet in QualityDocs (such as process navigation and glossary hover-over functionality).

- Quality Docs

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1RMC is a new model for Medical Compliance across Roche, designed to ensure we continue to bring our solutions to patients safely and compliantly.

- Medical Compliance Governance

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in list Risk Assessment

Please add your name to the sign-in sheet on the "Recording: Risk & QS" tab once you have watched the recording so your training can be credited in Cornerstone

- Risk Assessment - Quality Strategy training slides

- Video recording

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QMS Process Landscape and GPO Process Assignments

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QMS Process Landscape and GPO Process Assignments

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- GPO Hub

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in list PDQ_QAx Systems & Tools

The Audit Toolkit where you will find everything you need for your audit: Templates, GVP, GCP and GXP Modules with 'Focus Area Generators', useful Tools, links to training and much more.

- Audit Toolkit

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in list Key Training

Impact Factors are focus areas of activities presenting greatest risk or opportunity. Each Impact Factor has a target Quality Position and may have sub-positions. Impact Factors from the foundation of the Quality Strategy and drive the narratives across Process, Programs and Affiliate. See the Impact Factor Card in Risk assessment for the full details

Links to Review

- Additional information is available in the following Business Instruction Document: BI-0300049

- Quality Positions & Impact Factors

- Development Molecule QPL List

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in list Risk Assessment

- Product Risk Assessment Guidance and Risk Tracker Tool

- Molecule Risk and Issue Tracker Tool and Impact Factor Execution Strategy Template

- AL and PL risk documentation and tool - being developed please reach out to your manager or buddy in the meantime

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in list PDQ_QAx Systems & Tools

This site provides information, tools, training, and resources related to Clinical and Safety Finding Management (CSFM) from self-identified deviation, audit, or inspection.

- QUEST Hub gSite

- OneQMS Hub Will replace QUEST in 2023

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in list Key Training

Business Instruction (BI-0300049, PDQ: Quality Assurance sub-functions (QAx) Strategic Planning) for the end to end QAx strategic planning.

- QAx Hub - QAx Strategic Planning

- BI-0300049

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in list PDQ_QAx Systems & Tools

In addition to the systems and tools already covered, review the following spreadsheet for a full list of systems, including descriptions, which Impact Factors and how to gain access.

- Direct link Useful Systems, Tools and Links

- Link to gSite where the Useful Systems, Tools and Links is housed

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in list Key Training

QUEST Hub
Your one-stop shop for information, tools, training, and resources related to Clinical and Safety Finding Management. If you are involved with a Finding that resulted from a self-identified deviation, audit, or inspection, you are in the right place

QUEST System
The QUEST system is the new system for managing Findings against Roche GCP and GVP processes that result from all three types of Quality Events (audits, inspections, and self-identified deviations). The QUEST system sits on the cloud-based Veeva Vault platform and replaces the legacy QPP and pDeviation systems.
Confirm with your manger if access to QUEST is needed and what type of access. Once confirm you manager must submit a ticket to initiate the training process for you. Please see the QUEST Hub Onboarding page

Please note: if you have access to both QUEST and QualityDocs, the system will automatically take you where you were logged in last time. You can switch between the two instances by clicking the arrow next to "Quality Production" section in the top right corner.
Quality Pharma = QualityDocs
Quality Production = QUEST

- Audit and Inspection Lead - System Access Training

- Reviewer Pool - System and Process Training

- CAPA Effectiveness Verification Audit Manual

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in list PDQ_QAx Systems & Tools

QART, is the QA Resourcing Tool designed using the Quickbase solution and used by QAx. (Quickbase is a cloud database software platform for creating custom business solutions that anyone with a little training can build to solve everyday business challenges. It’s a powerful workspace, used across PDQ, that helps teams be more efficient by empowering the people closest to the work to quickly build business applications that match their exact processes.)

- QART If you have access issues, please contact Sandrine Alvado-Stroehmann.

- QAT (QPL Assignment Tool), is an app in Quickbase that manages the Molecule/Post Approval Portfolio Decisions. QAT automatically pulls critical information from various source systems, flag changes from one LSP report cycle to the next, and has a real-time connection with QART. For more details on QAT, please click here.

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in list Key Training

The Quality Program Lead (QPL) is responsible for developing the molecule-specific Quality Strategy, an associated program of audits and production of the molecule QBD.

- QPL toolkit The QPL provides all the processes and tools for the QPL activities. The links below are all accessible via the toolkit, but call out again for ease of reference

- QPL Molecule Manual. QPL Product Manual.The QPL Manuals (Product and Molecule) describe the ‘When’ and ‘How’ PDQ-Quality Assurance Programs (PDQ-QAP) QPL deliver the Development Molecule or Post Approval Product work.

- Review and understand the Impact Factors and Impact Factor Tools Impact Factors are focus area presenting the greatest risk or opportunity defined for (1) patient protection and (2) reliability of clinical results and PV system. Each Impact Factor has a target Quality Position and may also have Quality Sub-positions.

- Quality Strategy & Reporting Out Templates. The Quality Strategy is the plan that lays out the audits needed to write a conclusion against each Impact Factor and it’s quality position. QSRC enables visibility of the strategy and the likely/evolving narrative.

- Useful Systems & Links: A list of useful product and molecule related systems and links (detailing training, access and Impact Factor alignment).

- Risk Tracker under Molecule and Product toolkit

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in list PDQ_QAx Systems & Tools

Clinical Trial Management System (CTMS), a central repository for study information on all Roche sponsored and supported trials.

Accessing this page requires Roche network or VPN/Pulse Secure connection.

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in list Key Training

The purpose of GCP inspections is to examine clinical trials at the premises of Roche, contract research organizations (CROs), research organizations or units and clinical trial centers. These inspections may focus both on the way trial centers are conducting a trial and how Roche or contracted companies are managing the trial.

GVP inspections examine the pharmacovigilance system and processes in place at Roche and service providers contracted by marketing authorization holders (Roche) to carry out pharmacovigilance activities on their behalf. GVP inspections examine whether the processes followed comply with the applicable national laws, international pharmacovigilance directives and requirements of the Health Authority.

- PDQ Inspection Management Framework

- Inspection Management gSite

- QPL Inspection Resoucres

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in list Key Training

- In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746

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in list Key Training

- Introduction to the EU MDR

- Introduction to Medical Devices and Associated Regulations

- Module 1: Document Controls Overview for Medical Devices

- Module II: Document Controls Overview for Medical Devices

- Module 1: Design Controls Overview for Medical Devices

- Module II: Design Controls Overview for Medical Devices

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in list Key Training

Links to other important procedural documents

- GD-0300330 Global: Manage gSite Requirements

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in list Key Training

This exercise will develop your awareness of our business continuity planning, why business continuity is important and who is involved in the Business Continuity Team across PDQ.

- Familiarise yourself with the content in this Business Continuity module.

- Read the PD and PDQ Business Continuity Plan (BCP) Overview Site. See the actual PDQ BCP

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in list Audit (Evidence Generation)

- Complete Audit SOP training if not already done (See SOPs/QA focus card)

- Review audit toolkit

- Review existing audit reports and audit plans. Note: once RADA groups are updated you will receive all audit report. Self-subscription to audit type distributions lists is also available please click on this link for additional information. Accessing this site requires Roche network or VPN/Pulse Secure connection.

- Attend the report writing training (this is being planned - look out for invites and see the refresher video as a supplement/JIT))

- Review Report Writing Refresher Training Video

- eArchive: Electronic archive to access archived records (e.g. deviations, audit and inspeciton reports generated prior to QUEST)

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in list Connect

Description

Communities of Practice are intended as a place where you can go to share, learn and expand your knowledge and ideally consist of experts and people who are still developing expertise. They are not intended to replace the existing means by which we make decisions on day-to-day work.

Links to Review

- Data Analytics CoP

- CS CoP Community of Practice

- GCP CoP Community of Practice

- CS CoP Community of Practice

- CSFM PDQ SMEs

- CoP CS Slack channel: # cop-cs

- CoP GCP Slack channel: # cop-gcp

- CoP GVP Slack channel: # cop-gvp

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in list Data Mastery

Description:
Industry collaboration to engage with Health Authorities on the use of analytics to generate evidence and Quality Briefs (QDs).

- IMPALA website

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in list Quality Briefs

Description:

The intent of the Quality Briefs (QB) is to proactively provide parties external to PDQ (primary audience is the Health Authority) a meaningful and relevant summary of Roche’s confidence in the data collected and the processes followed for a particular entity in order to influence and effect positive outcomes. Entities may include molecules in development, post-approval products, affiliates or processes.

- QB Toolkit Includes the QB Manual and QB template, as well as the Writing and Reviewing Checklist. In addition, the QB Briefing Package Template and QB Talking Points are also availed to support QPLs in socializing (internally and with HA) the QB.

- There is work ongoing to further enhance the QB template and tools to increase reuse and the accessibility of the conclusions. Additionally the Chapter Lead for Quality Policy will be working on a strategy for engaging industry and regulators around the approval and maintenance of health care solutions, including how QBs supports the strategy.

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in list Your Training Plan

Description:

The training oversight includes the QAx mandatory training as well as the recommended training for all colleagues in QAx.

Links to review:

- QAx Capability & Training oversight

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in list Audit (Evidence Generation)

Description:
Impact Factors are focus areas of activities presenting greatest risk or opportunity. Each Impact Factor has a target Quality Position and may have sub-positions. Impact Factors from the foundation of the Quality Strategy and drive the narratives across Process, Programs and Affiliate. See Impact Factors Card in Risk Assessment for the full details

- https://trello.com/c/UoLlNTAi

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in list Connect

Description

QPL forums for Product and Molecule QPLs

Links to Review

- QPL Community QPL virtual community is a space to share ideas, blogs, interesting topics, news, and QPL agenda topics in order to increase our explicit and tacit knowledge sharing, and develop new ways of working.

- DARWIN - https://trello.com/c/q5QmTUX4

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in list Data Mastery

Description:

QUEST Analytics is a solution that brings the data utilization and transparency to all users globally enabling them to gain insights, have oversight and take timely action on all aspects of the QUEST processes.

- QUEST Analytics Self-Service

- QUEST Analytics Self-Service Training

- QUEST Analytics Self Service Resources

- QUEST Analytics Self-Service Graduate Certificate

- QUEST Analytics Dashboards and Reprots

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DAVE - The Fearless Quality Professional Competency Model

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DAVE - The Fearless Quality Professional Competency Model

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in list Your Training Plan

Description

DAVE - The Fearless Quality Professional Competency Model

The PDQ Talent Team is excited to be able to shape our evolution in PDQ from Gatekeepers of Quality to Accelerators of Healthcare Solutions. We call this evolution "The Fearless Quality Professional", complimented by DAVE, our PDQ competency model. This year, we will work on enhancing our PDQ Talent Strategy by building the DAVE sub-competency model process, including self assessments, opportunities for connectivity, and embedding the DAVE model into our culture and talent processes.

Links to Review

- To subscribe to DAVE's channel, click here

- Review the DAVE gSite

- Subscribe to "Let's Fika"

- DAVE Capability Assessment

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in list Audit (Evidence Generation)
Description:
The objective questions drive the evidence gathered in an audit. Specific objective questions suitable for tailoring are available for each Impact Factor within the Tool. However, these questions are just the starting point for the audit plan and scope.

The audit Proposal Owner should define the audit’s objective questions to be holistically measurable to support the Quality Narrative/Position & Strategy that meaningfully informs/contributes to the positive affirmation and current risk status of a program/product.

- Developing Objective Questions for Audits Guidance

- QPL Objective Questions Tool

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in list Data Mastery

Description:

Roche PD Quality launched the Data Analytics University, an internal center of excellence offering training to enhance the data competencies of its employees, in September 2018. The aim of the Data Analytics University is to demystify data terminology through a mix of theoretical knowledge and practical examples and help it’s staff to become data enthusiasts, applying their new skills to solve GxP quality problems and moving towards adopting a data-driven mindset fit for the 21st century.

Links to Review

- Certificate In Data Basics: This elearn module is recommend for all, but not a pre-requistie for the Data Analytic University (DAU) - Graduate Excel only course Objective The aim of this course is to provide a foundational level understanding in analytical capabilities so that the learner is capable of using and applying analytics tools to solve real-life GxP problems. Course Overview This interactive e-learning course is divided into 9 bite size chapters covering: Demystifying Analytics; Naked Statistics for Data Analysis; How Data Might Fool You. Sign-up via Cornerstone

- DAU Study Analytic Graduate Certification. The aim of this course is to build upon the existing capabilities acquired in the Certificate in Data Basics course and for learners to become confident in performing data analysis independently - whether that’s to answer a question using data, visualize the data or tell a story to key stakeholders using data.

- Data Analytic University (DAU) - Graduate Excel only. The (DAU) - Graduate Excel only course is an extract of the DAU Study Analytic Graduate Certification that focuses only on the Graduate excel module. The aim of this course is to build upon the existing capabilities acquired in the Certificate in Data Basics course and for learners to become confident in performing data analysis independently using advanced excel skills. This course is a 2 days ILT course (4 hours each day). Email notifications of the next offerings are send out for sign-up

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in list Audit (Evidence Generation)

Description:
Positive Affirmation evidence is a ‘’finding’’ of compliance to applicable regulatory, business and / or procedural requirements, based upon objective evidence.

- How to write Positive Affirmation Evidence - section 4.6

- Report 126 show Positive Evidence and Findings by Impact Factor

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in list Data Mastery

Description:

Statistics - training session.

Statistics boost training sessions aim to upskill the organization (PD and all departments across Roche) on relevant statistics topics and how to apply them effectively in drug development.

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in list Audit (Evidence Generation)

Description:
The QPL has a key role to play in the audit certificate process. They are responsible to reviewing and approving the AC for their program(s).

- Audit Certificate Toolkit Review the manual detailing the process and the role of the QPL

- Watch the Audit Certificate Process Awareness Session 12 Aug 2021

- Complete the DocuSign Training: To gain access to do eSignature, the following training must be completed via Cornerstone: - DocuSign User Training - DocuSign for GxP User Training

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Managing and Hosting Global Business Partner Audits

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Managing and Hosting Global Business Partner Audits

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in list Audit (Evidence Generation)

- BI-0300152 v 1.0 PDQ: Managing and Hosting Global Business Partner Audits

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in list Audit (Evidence Generation)

Description:
Dave unleashes the power of data by developing insights that propel the organizational strategy forward. The 'D' In Dave speak to the Data Drive Decision Maker covering:

Strategic Insights Analysis

Quality data storytelling

Critical Thinking

Please see the 'Your Learning Plan' card for all aspects of DAVE (not just Data)

- https://trello.com/c/lLRAGJj8

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in list Audit (Evidence Generation)

Description:
DARWIN stands for Delivering Quality AssuRance Where It’s Needed and represents the evolution of the QPL operating model. This re-imagined model is based on a squad structure which is composed of both Molecule and Post Approval Product QPLs, Quality Leads (QL) and a QPL Leader who all work on molecules or products with similar indications.

- DARWIN: A New QAP QPL Operating Model - PDQ Post

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in list Audit (Evidence Generation)

Description:

(The Research Quality Associate (RQA)]offer a range of (https://www.therqa.com/learn-develop-connect/courses-and-events/events/). Below of some of the key ones that may be helpful depending on your training needs. Please be sure to review with your manager before booking (note there is often benefit in group bookings as well).

-The Auditing Course Consider in value add or if the ACP and on-the-job training is sufficient)

- Practical PV Auditing.

- Good Clinical Practice Auditing - Principles and Practice

- Auditing Computerised Systems

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in list Audit (Evidence Generation)

Description:

The target audience is employees in an auditing role, with no or with little prior auditing experience, or technical Subject Matter Experts (SMEs) who will be joining an audit as co-auditors. The Auditor Certification Program shares the key elements in each audit step and builds the important skills (e.g. critical thinking, interviewing skill) to be an effective auditor.

The ACP training is optional! Please note: after completion of the in-class part of the program, you are required to lead 3 audits within the next 12 months in order to receive your certification.

- Auditor Certification Program gSite