Biotechnology

Wake Tech offers a variety of non-degree, short classes and certificate training programs in the biotechnology field, including hands-on training in biomanufacturing and biopharmaceutical operations in a simulated industrial, current good manufacturing practices (cGMP) environment.


Course Details & Registration Information

Course
Elements of Good Documentation Practices (GDP) and Data Integrity
Name
SEF-3001KJ1
Available Classes
    Section Location Begin Date End Date Instructor Price Seats Available/Total Seats
235750 Face-to-Face Online Instruction 10/16/2020 10/16/2020 G. Smith $70.00 25/25
Description Course Outline Requirements Intended Audience More Details
Intended Audience
Pharmaceutical Production Associates, Production Managers, Quality Managers, Management, any employee who writes, edits, or compiles documents used in manufacturing FDA regulated products.
Description
An overview of Good Documentation Practices, including the differences between documents and records, the typical ISO 9001 document hierarchy, and each document level. Participants will 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 will be 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
  1. Define and distinguish pharmaceutical documents and records.
  2. Detail the regulatory requirements, functional purpose, and typical industrial uses of each document type.
  3. Review 21 CFR 11 requirements and resultant impacts on electronic signatures and record keeping.
  4. Recognize emerging regulatory expectations for data handling and data integrity assurance.
Outline of Instruction
  1. GMP documents
  2. GMP records
  3. Document control
  4. Good documentation practices
  5. 21 CFR Part 211
  6. Electronic records
  7. Qualifying Excel spreadsheets
  8. Data integrity
  9. Medicines & healthcare products regulatory agency
Contact Hours
4
CEU's
0.4
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
Text and Supplies Needed
Provided by BioNetwork
Clinical Site/Special Facilities
Requirements for Successful Completion of this Course
  1. Attendance 100%
  2. Participation
Accreditation/Special Approval Requirements
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
Industry or Job Titles Related to training Outcomes for Employment
  • Pharmaceutical Production Associates
  • Production Managers
  • Quality Managers
  • Management
Related Courses
  • Medical Devices, CGMPs and ISO Overview - SEF-414CL
  • Elements of Current Good Manufacturing Practices in Biomanufacturing Processes - SEF-79524
Course Contact Information
Bionetwork Manager