This Web Seminar will present a comprehensive overview of the cleaning process for equipment and facilities in the pharmaceutical industry. We will begin by advancing the concept of a cleaning and cleaning validation life cycle. This will define three distinct phases in the process, namely; development, execution, and implementation phases. We will discuss each phase and its role in developing the procedures and protocols and how they contribute to the continuous improvement of cleaning in the pharmaceutical industry.
The development phase will be based on defining the regulatory requirements for a cleaning SOP as documented in many examples of FDA 483 notices of adverse findings given to companies in the industry. Once the regulatory requirements are defined, we will outline the structure of a general cleaning SOP and provide examples of the information it should contain. We will then discuss preparing the cleaning validation protocol and many of the aspects associated with it, such as how to set acceptance criteria, analytical methods used in the validation, and how to measure cleanliness.
The execution phase discussion will address issues such as validating the cleaning process/procedure, what to do when cleaning validation fails, manual versus automated cleaning, and revalidation requirements. The role of Change Management in improving cleaning and defining revalidation will also be discussed.
The implementation phase discussion will focus on the idea of monitoring the effectiveness of the cleaning, identifying trends and what to do about them. In addition, we will discuss extending the knowledge gained from monitoring to addressing new cleaning challenges.
By attending this presentation you will learn:
- The life cycle approach to cleaning and cleaning validation
- What are the cleaning regulatory requirements
- How to prepare a cleaning procedure
- When to clean and how long it would remain clean
- The contents of a cleaning validation protocol
- How to define cleaning acceptance criteria
- What are he various sampling methods
- Where to sample for residual during the validation effort
- What are the appropriate analytical methods to use
- How to look for and identify potential problems
- How to address issues associated with executing a cleaning validation
- Setting a monitoring program and the concept of continuous improvement
FEE:
$700 for 2-5 people
$999 for 6-10 people
Instructor: Gamal Amer, Ph. D.
Dr. Amer is Principal at Premier Compliance Services, Inc.; Management Consultants for compliance and manufacturing operations performance in the life sciences industry. He holds a Ph. D. in Chemical Engineering and has over 30 years of experience in the Pharmaceutical and related industries. He has held positions of increased responsibility with leading pharmaceutical, consumer product and engineering consulting firms over the years. His experience includes comprehensive process design in bulk pharmaceutical manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations. Dr. Amer is a recognized expert in GMP compliance and validation. He has consulted for many of the leading pharmaceutical, biotechnology and medical device manufacturers. He has lectured extensively in the US, Europe, Asia and the Middle East, taught many courses, and authored many papers which were published in peer reviewed publication. He is a member of ISPE, PDA, ACS and AIChE.
