Course Offerings

An overview of Good Documentation Practices, including the differences between documents and records, the typical ISO 9001 document hierarchy and each document level. Participants become familiar with record-keeping requirements, including the electronic signature and other regulations in 21 CFR Part 11. Additionally, the appropriateness and qualification of Excel spreadsheets for record-keeping is reviewed, along with how general good practices incorporate FDA compliance requirements outlined in the Guidance to Industry document Data Integrity and Compliance with cGMP.

Course Objectives

Define and distinguish pharmaceutical documents and records

Detail the regulatory requirements, functional purpose, and typical industrial uses of each document type.

Review 21 CFR 11 requirements and resultant impacts on electronic signatures and record keeping.

Recognize emerging regulatory expectations for data handling and data integrity assurance.

Outline of Instruction

GMP documents

GMP records

Document control

Good documentation practices

21 CFR Part 211

Electronic records

Qualifying Excel spreadsheets

Data integrity

Medicines and health care products regulatory agency

Contact Hours

8

CEUs

1

Industry Standard, State or National Certification

Certification

None

Website

None

Certification Learning Outcomes/Requirements

CE or CU Articulation

No

Prerequisites

N/A

Learning Supplies Needed

Instructor-provided supplies

Clinical Site/Special Facilities

N/A

Requirements for Successful Completion

100% attendance

Accreditation/Special Approval Requirements

N/A

Intended Audience

Pharmaceutical production associates, production managers, quality managers, management, any employee who writes, edits or compiles documents used in manufacturing FDA-regulated products

Specific Industry or Business Support Needs

Bioprocess cell technicians, pharmaceutical production associates, production managers, quality managers, management, any employee who writes, edits or compiles documents used in manufacturing FDA-regulated products

Wake County Need for Industry Positions

https://www.ncworks.gov/vosnet/JobBanks/JobSearchCriteriaQuick.aspx?pu=1

Industry or Job Titles Related to Training Outcomes for Employment

Bioprocess technician

Pharmaceutical production associates

Quality control manager

Quality assurance manager

Related Courses

BTC-3200A7

Course Contact Information

[email protected]