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NCTM1103 – cGMP Procedures and Documentation
August 31, 2020 @ 8:00 am - 5:00 pm
Online Course*
Description
This asynchronous online course explains the expectations of and reasoning behind proper documentation protocols mandated in current Good Manufacturing Practice (cGMP) environments, like pharmaceutical production facilities. Topics include principles of data and information entry, technical writing, recording guidelines, document control, and process documentation, including laboratory notebooks, logbooks, standard operating procedures (SOPs), and batch production records (BPRs). Participants will understand the entire documentation pathway from R&D to commercialization of product, including corporate, R&D, manufacturing and qualification/validation.
What you will learn
- Introduce regulations in pharmaceutical industry, FDA, cGMP, cGMP requirements, Title 21 CFR, federal documents, FDA enforcement, correspondence for nonconformance, importance of documentation, GMP records, “documentation pyramid ”, regulatory pathway of drug development, stages and measurable claims
- Understand document control, legal requirements for record maintenance, features of controlled documents, systems integrity, change control, recording guidelines for entering data/ making corrections/ signaling data/ reporting deviations/ corrective and preventive actions, reporting to FDA, identifiers and samples, internal auditing, risk levels, employee documentation and training
- Learn about R&D documents/ development protocol/records/reports/procedures, log, books, SOPs- SOP development, types, writing, flowchart use. Understand use of batch records, qualification documentation/ activities, validation documentation/plan.
- Illustrate the importance of fundamental technical writing, recording original data, data collection, making entries in lab notebook, recoding laboratory procedures/inventions. Ideas, attachments, referencing and blank space.
Section Description
Online Course – Further instruction will be sent after registration.