Senior Compliance Scientist
Current Good Manufacturing Practices (CGMP) Training Package
Do you know what can happen to a manufacturing facility and its employees if it is out of compliance with CGMP? FDA issued more than 600 warning letters due to violations of CGMP in 2013.
Companies that engage in the manufacture of pharmaceuticals, biopharmaceuticals, medical devices, and combination products must follow CGMP not only in commercial factories, but also in manufacturing for clinical trials, for clinical trials themselves, and for anything else that impacts a product that goes into a patient.
CGMP extend to compounding pharmacies as well, where a licensed pharmacist combines, mixes, or alters ingredients in response to a prescription to create a medication tailored to the medical needs of an individual patient.
This training package will help you increase your awareness of CGMP and comply with 21 CFR Part 211.
This product includes the following universal documents and templates, all in editable format:
- CGMP Basics
- Regulations and Regulatory Agencies
- Consistency of Regulations Worldwide
- Major Elements of CGMP
- Good Documentation Practices (GDP)
- Linking CGMP and Compliance
- Impact of Non-Compliance
- Responsibility for CGMP
Kymanox estimates that it would take a qualified contractor 120 hours (80+40) to complete the work included in this package.
This estimate is based on our extensive experience creating these and other templates and procedures, as well as averages that we have observed across the industry.
Please use the calculator at right if you would like to see how your own calculations affect the dollars and time saved by purchasing our package. You can replace the numbers for "Effort Hours to Complete" as well as "Labor Rate" in order to see differences.
Labor Rate is defined as the overall cost of one employee per hour (including pay rate and benefits), or the overall cost of one qualified contractor per hour. Kymanox estimates this at $60/hour for a qualified contractor.
Available Hours Per Day refers to the number of hours a single resource has to work on the project per day. 8 hours assumes that the resource is fully dedicated to the project.