Pharma / Biotech
This course provides practical guidance on cleaning validation regulatory compliance, in conjunction with process validation principles to facilitate reasonable and informed decision making and activity planning. Regulatory requirements and the latest industry practices will be included in the discussion to identify questionable practices that may be misdirected as well as the better practices that support and align with current process validation principles. The program will describe a risk-based approach for establishing an effective cleaning validation program, including the development of policies, master plans and the appropriate content for each study to be performed incorporating critical quality attributes and critical process parameters and process control. In addition, validation maintenance and life cycle aspects will be reviewed. Cleaning validation examples will be included from different sterile and non-sterile product types, and different types of dosage forms including oral, topical, and injections. Concepts will apply to any FDA regulated manufacturing including drugs, supplements, personal care, medical devices. Additional benefits of this class include interacting and learning from peers. Participants will have the opportunity to discuss their challenges and problems.
Additional benefits of this class include interacting and learning from peers. Participants will have the opportunity to discuss their challenges and problems.
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
Attendance at this two-day course will be beneficial to personnel directly involved or supporting the development of cleaning validation programs and plans, also those responsible for cleaning validation protocols and execution activities, as well as beginning or experienced personnel who may eventually participate in such efforts. This includes validation, engineering, operations, and laboratory personnel, also Analytical Method Development, Quality Control and Quality Assurance personnel.
Individuals in management who interact internally with these teams or externally with regulatory agencies will also benefit from attending this course. There are no prerequisites for attending, but a basic knowledge of general science and process validation is helpful.
Why Clean? Manage Risk of Batch to Batch Contamination
Review of Industry Practice
Better Practices to Implement a Robust Cleaning Validation Program
Evaluate Equipment and Residues- Risk Assessment
Cleaning Process Fundamentals
Define and Control Critical Process Parameters (CPPs)
Establish Scientifically Sound Contamination Limits
Better Practices to Implement a Robust Cleaning Validation Program (cont.)
Develop and Qualify Inspection and Control Methods
Select and Justify Acceptance Criteria and Qualification Test Plans
Install a Life Cycle Management Program for Cleaning Validation Maintenance
Discussion Topics and Forum
By the end of this course attendees will:
"I found the course to be useful in establishing a general outline of what will be required when moving to a matrix approach to our cleaning validation program. I found course materials and the instructor to be very knowledgeable and helpful." Dean R., Senior Technician, Teva Pharmaceuticals
"Good amount of material and well presented. Excellent job engaging attendees and tailoring discussion." TJ W., Lead Investigator, Adhesives Research
"Good presentation. I now have a better understanding of Cleaning Validation and I can start applying what I learned immediately to ensure that my firm is in full compliance." Jaime S., Director - Regulatory Compliance, MeriCal, Inc.
"The Course Director was very good at encompassing all I wanted. There were good examples and sample problems. I enjoyed the small group setting that allowed easy interaction with the instructor. We had good group discussions/debates and worked out problems well together. An excellent course for beginner CV personnel." Kristen H., Process Validation Engineer, Shire HGT
"This was an excellent seminar - the best Cleaning Validation training I have ever attended! The Course Director was an engaging presenter. This seminar is applicable to both new and seasoned professionals that are interested in learning about cleaning validation." Samuel L., Site General Manager, ISP
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*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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