Why is it required to follow these regulations? This seminar will provide a review of cGMP regulations with explanations that will demonstrate the benefits of complying with these simple rules. This is the best time to learn Good Compliance Practices from a former FDA Investigator and CDER Compliance Officer.
If you receive a Warning Letter pertaining to Data Integrity or your firm is placed on the Import Alert List, you may have to stop manufacturing, recall your products, train all of your employees, validate your manufacturing processes, validate your data, testing methods and re-qualify your equipment. You will also be required to hire consultants.
This will cost you millions of dollars and could take several years to re-start your production. You will not obtain any new NDA or ANDA approvals and you will not be able to submit any changes to your already approved applications. Your stock price will go down. You may lose your customers and you may have to close your facilities.
This Webinar will help your firm to remain in good compliance with the US FDA. Discussion will include methods for maintaining a continuous quality improvement program thereby keeping your site ready for regulatory inspections all of the time.
- Learn Good Compliance Practices from a former FDA Investigator and CDER Compliance Officer
- Understanding Latest cGMP Regulations
- Production and Process Controls, Validation and Laboratory Controls
- Data Integrity
- Potential negative consequences of non-compliance
- Methods for avoiding FDA-483 observations
- Recent Warning Letters and Import Alerts issues
- Learning from competitors’ mistakes that could prevent you from making these same mistakes
- Regulatory Affairs Departments
- Quality Departments
- Compliance Departments
- Research and Development Departments
- Engineering Departments
- Manufacturing Departments
- Production Departments
- Validation Departments