Course Duration
Participants can select up to 6 from the above topics. Each topic's duration is 4 contact hours.
Course Topics
1. Auditing Strategies
A well structured Audit System provides assurance that the overall quality systems are in compliance. This half day intensive course shows where and how to focus on systems that frequently show problems needing correction.
A well structured Audit System provides assurance that the overall quality systems are in compliance. This half day intensive course shows where and how to focus on systems that frequently show problems needing correction.
2. Batch Records.
Over the last 40 years batch records have grown more and more complicated. There is a wide spread trend of restructuring batch records to make them simpler, easier to prepare and review. This course discusses the purpose of batch records, what the EU and US regulations require and how to streamline batch record processes.
Over the last 40 years batch records have grown more and more complicated. There is a wide spread trend of restructuring batch records to make them simpler, easier to prepare and review. This course discusses the purpose of batch records, what the EU and US regulations require and how to streamline batch record processes.
3. Microbiology Trends in Non-Sterile Products. (Tablets, Capsules, Creams and Ointments)
The current practices for these products has been changing in recent years. These new practices and how to implement them will be discussed.
The current practices for these products has been changing in recent years. These new practices and how to implement them will be discussed.
4. cGMPs for the Maintenance and Engineering Functions
The utilities (Water, Compressed gasses, HVAC, Calibration and Building Maintenance Systems ) current changes and their challenges will be discussed.
The utilities (Water, Compressed gasses, HVAC, Calibration and Building Maintenance Systems ) current changes and their challenges will be discussed.
5. Data Integrity
This is a new area that is a frequent source of adverse audit findings. What defines data integrity issues and how to address them will be covered.
This is a new area that is a frequent source of adverse audit findings. What defines data integrity issues and how to address them will be covered.
6. Writing Procedures and setting Specifications
Generating procedures and test specifications that can and will be followed that can and will be followed will be covered.
Generating procedures and test specifications that can and will be followed that can and will be followed will be covered.
7. Quality Systems
What is a Quality System? What are the most important Quality Systems and what are the metrics used to determine if these systems are working?
What is a Quality System? What are the most important Quality Systems and what are the metrics used to determine if these systems are working?
8. The QC Laboratories
The critical issues including method validations, test failures (OOS), investigations and corrective actions will be addressed.
The critical issues including method validations, test failures (OOS), investigations and corrective actions will be addressed.
9 . Five Whys
The Five Whys approach to finding the root cause of a failure or deviation is currently one of the hottest topics being implemented in our industry. Mr. Marshall will first explain what "Five Whys", then using several case studies, participants will learn how to employ this powerful tool to get to the bottom of a problem's root cause.
The Five Whys approach to finding the root cause of a failure or deviation is currently one of the hottest topics being implemented in our industry. Mr. Marshall will first explain what "Five Whys", then using several case studies, participants will learn how to employ this powerful tool to get to the bottom of a problem's root cause.
