cGMP or current good manufacturing practices are not limited to product development and monitoring of the SOPs. Everything plays an essential role, starting from the design of the facility, the strength of the unit, and the purity of the components.
Do you have the proficiency to update cGMP to its core? You will, after attending this cGMP training! The core purpose of this seminar is to establish a robust idea of how the quality of active pharmaceutical ingredients. Get to know more about this seminar in the following sections.
Since a basic cGMP course is not sufficient to ensure quality, the effort is to improve the overall conditions under which a pharmaceutical product is manufactured. As a result, you will see a dip in cGMP violations, and the operations will improve significantly.
Curious to know the agenda of this seminar? Here is the list for you!
Do you have the proficiency to update cGMP to its core? You will, after attending this cGMP training! The core purpose of this seminar is to establish a robust idea of how the quality of active pharmaceutical ingredients. Get to know more about this seminar in the following sections.
Course Overview
Do you think a consumer will be able to assess the quality of the drug? This is difficult by just smelling, touching, or looking at the final product. Hence, you need thorough pharmaceutical GMP training to ensure every consumer receives high-quality drugs.Since a basic cGMP course is not sufficient to ensure quality, the effort is to improve the overall conditions under which a pharmaceutical product is manufactured. As a result, you will see a dip in cGMP violations, and the operations will improve significantly.
As per FDA GMP inspection guidelines, here are some controls they focus on:
- Improving management systems
- Reliable testing of the samples, raw materials, and final products
- Developing strict operating procedures
- Consistent work on reducing the deviations
- Procuring quality raw materials
- Thorough investigations of the deviations
Curious to know the agenda of this seminar? Here is the list for you!
Course Content
Session 1: U.S., EU, and Japan GMPs - Status of Harmonization& Future Trends
Session 2: APIs
Session 3: Area GMP Inspections
Agenda
Session 1: U.S., EU, and Japan GMPs - Status of Harmonization & Future Trends- Current status of harmonization of GMP requirements
- Future Trends
- Where Inconsistencies Become a Problem: WHO, ICH, Countries
- Discrepancies in global expectations
- Alignment issues
- Key Chapter Reviews
- ICH GMP organization
- Category reviews
- Compliance with ICH Guidelines for GMPs
- Understanding and Insight into Healthcare Authority expectations
- How GMP requirements/inspections can differ from a single ICH Standard
- How regulators (from 3 regions) will assess/enforce compliance with Q7
- Auditing API facilities
- Typical audit agenda
- ICH Area differences
- Finished Products
- Auditing finished product facilities
- Typical audit agenda
- ICH Area differences
- Excipients
- Sterile products
- Biologics
- Clinical Packaging
- Differences in how GMP inspections are conducted.
- Areas of GMP inspection focus by area
- Modifying your self-inspection systems to customized area concerns.
- Contract Manufacturing
- Contract packaging.
- 3rd Party Contract testing
- Auditing Your Facilities for Global Considerations
- Importance of pre-audits to regional GMP focus.
- How to focus your internal audits on a US, EU, and Japan compliance system
Course Provider
Kelly Thomas,
