Records, Archiving, and Retention

5/5
76
record archiving gxp gcp gmp

Duration :

2

1 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course : 

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

Hardly can one say they have been educated on pharmaceutical manufacturing without having come across the saying “if it wasn’t documented, it never happened”. This emphasizes the importance of documentation in the manufacturing process. This is what this course is about.

Participants will learn about how documented information is managed based on relevance and age (archiving and retention). You will also learn about how such information can be leveraged for future changes to the production process.

 

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice

 

Curriculum

 

Introduction

 

Lesson 1: What Are Good Data and Record Management Practices?

 

  • Need for Good Data and Record Management Practices
  • What Comes Under Good Data and Record Management Practices
  • Who Is Responsible for Good Data and Record Management Practices?

 

Lesson 2: Implementation of Good Data and Record Management Practices in GXP

 

Lesson 3: Life Cycle of a Record

 

  • Data Collection and Recording
  • Data Processing
  • Data Review and Reporting
  • Data Retention and Retrieval

 

Lesson 4: Organization of Records System in A GXP Set-up

 

  • Hierarchical Document System
  • Level 1- Quality Manual
  • Level 2- Company Policies
  • Level 3- SOPs
  • Level 4- Batch Records, Tests Methods, Specifications, Validation Documents

 

Lesson 5: Master Document of a GXP Set-up: Site Master File

 

  • Components of a Site Master File

 

Lesson 6: List of Common Documents Maintained in GXP Set-up

 

  • Information Needed in Documents as Per GDRP
  • Document 1: Specifications
  • Document 2: Manufacturing Formula and Processing Instructions
  • Document 3: Packaging Instructions
  • Document 4: Batch Processing Records
  • Document 5: Batch Packaging Records
  • Document 6: Receipt

 

Lesson 7: Records, Archiving, and Retention Using GDRP Principles in a GXP Set-up

 

  • Key Points for Records
  • Electronic Record Validation
  • Record Maintenance, Retention, & Archiving

 

Glossary

 

Conclusion

 

Quiz

Author:

ciaran
Dr. Ciaran McEnister
Senior Pharmaceutical Executive with 25+ years of experience in Medical device development. Translational Research, Pharmaceutical development, Pharmacologic/Toxicologic and Preclinical research and Regulatory compliance of small and large molecule drug candidates. Dr. McEnister has an extended experience as senior quality manager at Merckx, BioDevices and IPSEN.

Reviews:

5/5
76
USD: United States (US) dollar ($) ^

$60

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This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

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$60.00

$60.00

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