Cleaning Validation Principles

Milan, 8-9 October 2008

Intermediate Level
ISPE CEUs*: 1.3
Type: Classroom Training Course

Instructor: Robert Walker, Rob Walker GMP Consultancy Ltd (UK)

Description

As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation programme. 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 programme.

This course will cover elements of a cleaning validation programme 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 programmes, concepts such as understanding process control, capability, learning to effectively self-audit a cleaning validation programme, and documentation will be essential take-aways.

Classroom Objectives

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, or 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
Practice hands-on exercises designed to reinforce core competencies and job-focused skills

Take Back to Your Job

Identify and characterise 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
Evaluate cleaning practices, limit calculations, scientific rationales, and validation documents through internal self-audits to ensure compliance with ever-changing regulatory needs

Attendance Suggested For

Professionals responsible for all aspects of cleaning validation programmes, including development, deployment, and maintenance; quality assurance and control, regulatory affairs, validation; manufacturing, and engineering. Additionally 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 would benefit from attending this course
This Training Course is of particular interest to existing and future members of the ISPE Active Pharmaceutical Ingredients (API), Containment, Biotechnology (BIO), Commissioning and Qualification (C&Q), Process Analytical Technology (PAT), Investigational Products (IP), and Process/Product Development (PPD) Community of Practice (COP)

Important Course Notes

This course contains knowledge related to the CPIPSM technical knowledge competency element Production Systems. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.


Training Programme General Information Venue and Area Information Sponsorship Opportunities Registration Information Download Brochure Current as of 28 May	Cleaning Validation Principles Milan, 8-9 October 2008 Intermediate Level ISPE CEUs: 1.3 Type: Classroom Training Course Instructor:* Robert Walker, Rob Walker GMP Consultancy Ltd (UK) Description As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation programme. 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 programme. This course will cover elements of a cleaning validation programme 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 programmes, concepts such as understanding process control, capability, learning to effectively self-audit a cleaning validation programme, and documentation will be essential take-aways. Classroom Objectives 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, or 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 Practice hands-on exercises designed to reinforce core competencies and job-focused skills Take Back to Your Job Identify and characterise 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 Evaluate cleaning practices, limit calculations, scientific rationales, and validation documents through internal self-audits to ensure compliance with ever-changing regulatory needs Attendance Suggested For Professionals responsible for all aspects of cleaning validation programmes, including development, deployment, and maintenance; quality assurance and control, regulatory affairs, validation; manufacturing, and engineering. Additionally 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 would benefit from attending this course This Training Course is of particular interest to existing and future members of the ISPE Active Pharmaceutical Ingredients (API), Containment, Biotechnology (BIO), Commissioning and Qualification (C&Q), Process Analytical Technology (PAT), Investigational Products (IP), and Process/Product Development (PPD) Community of Practice (COP) Important Course Notes This course contains knowledge related to the CPIPSM technical knowledge competency element Production Systems. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.