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Technical Writing and GMP Training

Independent Quality Consultants (IQC) offers a full range of consulting services including GMP training from basic to advance levels as well as Technical writing such as preparing Master Validation Plans and Quality Manuals at very competitive rate. Our consulting services ensures that projects are initially performed correctly and that FDA requirements are fully satisfied.

Technical Writing
* Developing Quality Manuals, Policies and Plans, Standard Operating Procedures (SOPs), Work Instructions, Test Methods, Specifications, and Change Controls.
* Developing Validation Manuals, Validation Master Plans, Protocols, and Reports
* Developing Reliability Manuals, Policies, Standard Operating Procedures (SOPs), and test Instructions
* Development of presentation materials and a lesson plan.
* Communicating complex information in clear and concise way to those who need it to accomplish organizational tasks or goals.
* Following development and product lifecycle for:
1. Identification of needs, audience(s), and scope
2. Planning
3. Research and content development
4. Testing, review and revision
5. Delivery / production
6. Evaluation and feedback
7. Disposition (revision, archiving, or destruction)

* cGMP (21 CFR 210 & 211, 820 & 11)
* ISO 13485
* Validation
* Auditing
* Records and Recordkeeping Practices
* Root Cause Analysis and CAPA
* Risk Analysis and Hazard Assessment
* Statistical Analysis
* Risk Management, System Safety Engineering, PHA, SHA, SSHA, HAZOP, FTA, ETA, ESD, MLD, D/P/U/SFMEA
* Reliability, Maintainability, Availability
* TQM, DOE, SPC, Capability Analysis
* DFSS, Six Sigma, and Lean Manufacturing