About the course

Includes: - 20 pre-recorded webinars - PDF documents as additional resources - Google Doc Templates - A pop quiz for each lesson - An 80-question final exam - Training certificate

Curriculum

17 Chapters · 47 Lessons

    1. Intro to Auditing Free preview
    2. Quiz: Intro to Auditing Free preview

    1. ISO 13485 - Stage 1 Free preview
    2. Quiz: ISO 13485 - Stage 1 Free preview
    3. ISO 13485 - Stage 2 Free preview
    4. Quiz: ISO 13485 - Stage 2 Free preview

    1. Audit Roles & Responsibilities Free preview
    2. Quiz: Audit Roles & Responsibilities Free preview

    1. (Included in full purchase)

      ISO 14971

    2. (Included in full purchase)

      Quiz: ISO 14971

    1. (Included in full purchase)

      Auditing Logistics & Agenda

    2. (Included in full purchase)

      Quiz: Auditing Logistics & Agenda

    1. (Included in full purchase)

      Value Added Auditing

    2. (Included in full purchase)

      Quiz: Value Added Auditing

    1. (Included in full purchase)

      8.A: QMSR 21 CFR 820

    2. (Included in full purchase)

      8.A: Quiz: QMSR 21 CFR 820

    3. (Included in full purchase)

      8.B: FDA QMSR Inspection

    4. (Included in full purchase)

      8.B: Quiz: FDA QMSR Inspection

    5. (Included in full purchase)

      Inspection of Medical Device Manufacturers (Compliance Program Manual)

    1. (Included in full purchase)

      Checklists

    2. (Included in full purchase)

      Support Material: FRM-035 v0.1 ISO 13485-2016 Clause Traceability Matrix

    3. (Included in full purchase)

      Quiz: Checklists

    1. (Included in full purchase)

      Turtle Diagrams & The Process Approach

    2. (Included in full purchase)

      Quiz: Turtle Diagrams & The Process Approach

    1. (Included in full purchase)

      Interviewing Auditees

    2. (Included in full purchase)

      Quiz: Interviewing Auditees

    1. (Included in full purchase)

      Clause 6 Video

    2. (Included in full purchase)

      Clause 6

    3. (Included in full purchase)

      ISO 19011 - Part 1

    4. (Included in full purchase)

      ISO 19011 - Part 2

    5. (Included in full purchase)

      Quiz: ISO 19011

    1. (Included in full purchase)

      Sampling

    2. (Included in full purchase)

      Quiz: Sampling

    1. (Included in full purchase)

      Training & Qualification

    2. (Included in full purchase)

      Quiz: Training & Qualification

    1. (Included in full purchase)

      Auditor Notes

    2. (Included in full purchase)

      Other Note Taking Resources

    3. (Included in full purchase)

      Quiz: Auditor Notes

    1. (Included in full purchase)

      Writing Nonconformities

    2. (Included in full purchase)

      Quiz: Writing Nonconformities

    1. (Included in full purchase)

      Grading Findings

    2. (Included in full purchase)

      Support Material: GHTF Nonconformity Grading System for Regulatory Purposes and Information Exchange

    3. (Included in full purchase)

      Support Material: MDSAP AU P0037.001

    4. (Included in full purchase)

      Quiz: Grading Findings

    1. (Included in full purchase)

      Audit Report Writing

    2. (Included in full purchase)

      Support Material: Audit Agenda & Report Template

    3. (Included in full purchase)

      Quiz: Audit Report Writing

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