Cleaning Validation Principles (T17)

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Training

Level: Intermediate to Advanced
ISPE CEUs: 1.3
Type: Classroom Training Course

Date	Location	Country	Instructor(s)
9-10 September 2013	Burlingame (San Francisco area), California	USA	Rebecca Brewer
7-8 October 2013	Prague	Czech Republic	Rob Walker
9-10 December 2013	Tampa, Florida	USA	Rebecca Brewer

Description

As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation program. FDA's risk-based regulatory initiatives focus new attention on the risks of cross-contamination. The solution is to understand life cycle management techniques for an effective cleaning validation program.

This course will cover elements of a cleaning validation program from start to finish, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors. For mature cleaning validation programs, concepts such as understanding process control, capability, learning to effectively self-audit a cleaning validation program, and documentation will be essential takeaways.

Course Modules

Developing, Deploying and Maintaining
Regulatory Requirements
Fundamentals of Cleaning Validation
Master Plans
Equipment Characterization
SOP Development
Selecting Residues, Developing and Maintaining Limits
Methods Validation and Recovery Studies
Engineering Studies and Cycle Development
Creating Cleaning Validation Protocols
Collecting and Testing Validation Samples
Validation Reports

Take Back to Your Job

Identify and characterize potential residues including product, processing aids, cleaning agents, and adventitious agents
Apply appropriate analytical methodology for selected residues
Determine suitable sampling techniques and the selection of sampling locations that present a challenge for the cleaning process
Calculate residue limits that meet all necessary regulatory requirements
Create scientifically sound rationales, validation protocols, and reports
Manage the challenges of multi-product facilities in the establishment of limits, determination of validation strategies, and maintaining the validated state
Understand campaign-based production strategies for effective and scientifically sound validation
Differentiate the requirements for cleaning validation when using manual, semi-automatic, and automatic cleaning technologies
Determine scientific grouping or bracketing approaches
Comprehend the pitfalls inherent in cleaning after the production of biopharmaceutical and pharmaceutical products
Accomplish analytical method validation and recovery study requirements in cost-effective studies that provide the necessary assurance of an analytical system
Evaluate cleaning practices, limit calculations, scientific rationales, and validation documents through internal self-audits to ensure compliance with ever-changing regulatory needs
Practice hands-on exercises designed to reinforce core competencies and job-focused skills

Attendance Suggested For

Professionals responsible for all aspects of cleaning validation programs, including development, deployment, and maintenance
Quality assurance specialists, quality control technicians, regulatory affairs professionals, pharmacologists and toxicologists, validation scientists, and validation service personnel
Manufacturing supervisors, technical support personnel, and engineers responsible for evaluating cleaning systems, reviewing equipment, and supporting the cleaning validation program on the plant floor
All levels of management who need to understand the science of cleaning and cleaning validation including the aspects of residue selection, sampling method and analytical detection method validation, limits determination, and strategies for managing multi-product facilities

CPIP™ Technical Knowledge and Competency Elements

This course contains knowledge related to the CPIP™ technical knowledge competency elements Facilities and Equipment: Design and Construction / Installation and Production Systems: Production Control. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.

Continuing Education Units

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.

Last Update: 19 June 2013