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.
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
By adhering to this FDA GMP inspection checklist, you can avoid the most common quality failures in your manufacturing unit. The 58-page document on cGMP has excellent updates which will be discussed in this cGMP training.
Course Content
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 with a single ICH Standard
- How regulators (from 3 regions) will assess/enforce compliance with Q7
Session 2:
APIs
- 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
Session 3:
Area GMP Inspections
- Differences on how GMP inspections are conducted
- Areas of GMP inspection focus by area
- Modifying your self-inspection systems to customized area concerns
Outsourcing Management Regional Perspective on:
- 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 to a US, EU and Japan compliance system.
Course Provider
Ms Kelly Thomas,
Vice President ,
Stallergenes GreerMs. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
Who Should Attend
- Manufacturing
- Quality Control
- Quality Assurance
- Senior Management
- Project Managers
- Qualified Persons (QPs)
- Regulatory Compliance
- CMC Personnel
- Packaging Experts
- Auditors and Staff
- IT Subject Matter Experts
