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Cleaning Validation Roadmap

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May 21

San Diego, United States

COURSE DESCRIPTION:

An effective cleaning validation program is essential for a successful regulatory inspection. Over the years, it is a challenge for the industry to develop effective cleaning validation program that meets regulatory expectations. A cleaning validation program includes strategies for procedure development, product families, contact equipment, analytical methods, sampling and acceptance criteria. This seminar provides a roadmap to apply FDA’s Process Validation Life Cycle guidance and ICH Q9 Quality Risk core principles for cleaning validation program. This seminar also shows you how to develop safer, compliant and efficient cleaning validation program.

 

Top 10 Reasons to Attend:

  1. Know FDA 483s statistics specific and the top 5 observations
  2. Select analytical test method and understand validation methodology
  3. Apply ICHQ9 Quality Risk Management core principles for cleaning validation
  4. Master FDA’s Process Validation Guidance and a 3-stage approach
  5. Design cleaning process design and develop requirements – Stage 1
  6. Perform a cleaning Process Performance Qualification (PPQ) – Stage 2
  7. Set effective risk-based Continued Process Verification (CPV) program – Stage 3
  8. Understand documentation requirements for validation
  9. Set health-based limit and safety of margin
  10. Know global cleaning validation regulatory requirements (EU, FDA, Health Canada)

 

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Engineering
  • Regulatory Affairs
  • Compliance
  • Manufacturing
  • Laboratory

 

***Attend this event along with Advanced Cleaning Validation & Critical Cleaning Processes and save $200.00!  Select the dual event ticket type for $1790.00 to register for both seminars and save!***

Agenda

  • I.
    Global Regulatory Insight for Cleaning Validation Requirements
  • II.
    Risk-Based Analytical Science
  • III.
    Risk-Based Cleaning Validation Life Cycle Approach
  • IV.
    Cleaning Process Validation Documentation Requirements

Faculty

  • Brandy Koslop, Senior Regulatory Affairs Manager, Ecolab Life Sciences

    Brandy Koslop has over 15 years’ experience in regulatory affairs and quality within the pharmaceutical and antimicrobial chemical industries. She started her career in Microbiologist with Celltech Pharmaceuticals in environmental microbiology and validation. Brandy joined Ecolab in March 2005 in as a Quality Assurance Auditor, and has since held various positions such as Quality Assurance Manager, Lean Six Sigma Black Belt and Global Biocide Registration Manager. In her current role, Brandy works directly with government agencies on regulatory initiatives and provides regulatory and technical support to Ecolab customers, advising on cleaning and disinfection, and manages third party laboratories that perform disinfectant efficacy studies.
  • Grant Lindh, Senior Chemist, Ecolab Life Sciences

    Grant is a Senior Chemist at Ecolab for Global Life Sciences RD&E, supporting new product development and product portfolio management for offerings that serve Pharmaceutical, API, Biotechnology and Personal Care customers. As a formulation chemist, he brings technical expertise in building detergents for multiple industries and soil types. He works closely with Ecolab’s analytical team to develop corresponding test methods for detergent residues and works with customers to implement them during cleaning validations. He also provides testing advice and direction for Ecolab’s adjoining technical service group, helping to create and develop cleaning recommendations. Grant has worked at Ecolab for seven years in various product development roles.
  • Sunil Patel, Senior Global Technical Leader, Ecolab Life Sciences

    Sunil has over 13 years of experience working in the engineering and validation fields of cGMP/FDA/EU/ ISO regulated industry sectors. Sunil has a strong background in cleaning validation (CIP, COP, manual), process validation, process design, clean utilities (WFI, PW, clean steam, clean air, clean gases), HVAC, project management, sterilization and processing equipment validation. Further expertise includes process optimization/improvement, regulatory compliance and risk management methodologies for the pharmaceutical and biologics industry
  • Fred Ohsiek, Senior Cleaning Validation Specialist and Cleaning Validation Work Package Owner, Novo Nordisk

    Fred Ohsiek is the Senior Cleaning Validation Specialist and Cleaning Validation Work Package Owner for Novo Nordisk in Clayton, NC. He earned his Bachelor in Chemistry from University of South Florida. His professional work experience includes 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk. He was considered the cleaning validation subject matter expert in most positions held. His expertise includes developing, validating, and monitoring cleaning processes for equipment used to manufacture small molecule, peptide hormone encased, and large molecule pharmaceutical, OTC, and nutritional products. He has authored analytical and recovery methods to cleaning validation documents and has successfully defended legacy cleaning validation documents (i.e., created and legacy).

Sponsors

  • Ecolab is the global leader in water, hygiene and energy technologies and services. Every day, we help make the world cleaner, safer and healthier – protecting people and vital resources.
    Website: https://www.ecolab.com/

Partners

Venue

Details

Date:
May 21
Event Category:

Venue

The Dana on Mission Bay
1710 W Mission Bay Dr
San Diego, CA 92109 United States
+ Google Map
Phone:
(619) 222-6440
Website:
https://www.thedana.com/‎

Pricing & Registration

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