21 CFR Part 820

21 CFR Part 820 Subpart M – Records

Records are what we create to provide the evidence that we are following our procedures; therefore, they are extremely critical. It is important to remember that the records we generate must be admissible in court and therefore good documentation practices (GDP) are also important. Record alterations are considered a deliberate misrepresentation of facts. When an alteration is discovered during litigation it seriously undermines the ability to defend the claim of regulation compliance.

CEU Credits: 0.1

Course Code: ELM-313

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Introduction

Overview

ISO, ICH and the FDA

Program organization

Program objectives

Definition of a medical device

Class I, II and III

Intended use

History of 21 CFR Part 820

21 CFR 820 Timeline

1906 – The Jungle

1937 – Massengil Company

1957 – Thalidomide

1971 – Dalcon Corporation

1990 – FDA device recall report

A regulatory evolution

Records -Subpart M

Course Introduction

Learning Objectives

General Requirements

Good Documentation Practices

Signatures and Initials – Legally Binding

Signatures and Initials – Verification

Signatures and Initials – Signature Cards

Signatures and Initials – Asian Countries

Date and Time

Date and Time – Backdating

Handling Errors

Handling Errors - Blank Spaces

Significant Figures and Rounding of Numbers

Pagination

Footnoting

Records

Record Retention

Record Retention – DMR & DHR

Quality System Record

Complaints – Uniform & Timely

Complaints – MDR

Complaints – Reporting

Complaint Process

Complaint Trending

Complaint Closing

Conclusion

Final Exam

Certification

Author

Don Rackham

Associate Director QA Asterias Biosciences

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