Modern Cleaning Process Validation

Compliance with current regulatory expectations concerning cleaning is in flux. Regulation changes in the past few years have resulted in companies being cited for poor compliance with their cleaning approach. As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation program. Cleaning validation is a procedure for gathering & documenting evidence that cleaning processes (for pharmaceutical manufacturing equipment) will prevent product contamination/cross-contamination. Compliance with GMP Cleaning Validation requirements means collecting documented evidence that an approved cleaning procedure will reproducibly remove the previous product or cleaning agents used in the equipment below the scientifically set maximum allowable carryover level.

Why should you attend

This training course covers the risk-based approach to cleaning process design and development; cleaning process performance qualification; continued cleaning verification; risk analysis; procedures and evaluation tools, including  FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review, and communication. Clean-in-place design integration and cleaning chemical selection are vital components of every pharmaceutical manufacturing process; indeed, all pharmaceutical companies employ some cleaning application every day.  This training course will provide, in addition, an overview of clean-in-place (CIP) systems, including design, integration, and selection of cleaning chemicals. Participants will discuss engineering concepts, principles, and integration of CIP systems, clean-out-of-place (COP) systems, or immersion parts washers.

Learning Objectives

• Learn how Specific Regulations could be applied to cleaning validation processes
• Understand contamination control strategies and how they impact biopharmaceutical cleaning systems
• Apply a risk-based approach to cleaning process validation
• Identify and characterize potential residues, including products, 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

Who Should Attend

• Cleaning personnel and contractors, including independent suppliers of cleaning services for medical manufacturing industries, pharmaceutical product warehouses, and more
• Engineers designing cleanrooms
• Equipment purchasers and qualification/validation personnel
• Quality Assurance personnel
• Quality Control personnel
• Operations and Manufacturing personnel
• Qualification & Validation personnel
• Engineering and Automation personnel
• Anyone within the GMP industry interested in learning about or improving their knowledge of GMP and Validation requirements
• Job seekers seeking employment in the Pharmaceutical industry
• Life Science Graduates and Laboratory Personnel

Education Approach

• This training is based on theory and best practices used in the industry (FDA, ISPE, PDA, Health Canada, etc.).
• Lecture sessions are illustrated with examples based on case studies
• Practical exercises are based on a case study, which includes role-playing and discussions

Speaker

Kossi Molley, PMP, LSSBB, Chemist, Certified Trainer