Rethinking Cleaning Validation Of Pharmaceutical Manufacturing Equipment

Regulators are increasingly expecting to see a risk-based approach to cleaning validation, and manufacturers are continuously looking for ways to respond to these expectations in efficient and effective ways.

Rethinking Cleaning Validation of Pharmaceutical Manufacturing Equipment Seminar

Tuesday, May 9th – 11 am – 5 pm

North Carolina Biotechnology Center Dogwood Room
15 T.W. Alexander Drive, Research Triangle Park, NC

Register your attendance

In this free seminar, we will focus on bringing together the main pillars of an effective cleaning validation program: cleaning cycle, cleaning chemistry, test limits, equipment grouping, periodic monitoring and look into the future of what cleaning validation could look like.

Attendees will also put their learnings from the seminar towards solving a real-world, interactive situation and apply the discussed principles to improve the efficiency of the validation process.


Pharma/biopharma QA/QC, validation specialists, process engineers, and functions in manufacturing operations.

Title Description
11:00 - 12:00
Registration and Lunch
Networking lunch
CIP Overview & Optimization
Pete Barie, Sani-Matic
  • TACT (Time, Action, Chemical, Temperature)
  • CIP System Design considerations
  • CIP Supply & Return Distribution & Design
  • Automation & CIP Systems
  • Planning and avoiding pitfalls
  • ASME BPE Overview
Evaluating cleaning agent selection
Fred Ohsiek, Ecolab
  • Regulatory expectations on cleaning agents
  • Formulated vs Commodity cleaning agents – determining the best approach for your situation
  • Evaluation of cleaning agents based on soils
Equipment grouping considerations
Fred Ohsiek, Ecolab
  • Regulatory guidelines on grouping
  • Common mistakes when grouping equipment
  • Science and risk-based justifications for grouping
Managing Cleaning validation limits in a complex environment
Rizwan Sharnez, Ph.D.,
Cleaning Validation Solutions
  • Regulatory view on cleaning limits
  • Common pitfalls when setting limits for biologics
  • Science and risk-based cleaning limits options
How to design a science risk-based Routine Monitoring program
Vivek Gera, CEO, Leucine
  • Analyze product risk using FDA recommended framework
  • Analyze cleaning performance using the analytical (TOC/conductivity) data
  • Design a control strategy that optimizes the sampling requirements
  • Monitor the effectiveness of routine monitoring to maintain the state of control
Real-case example discussion Networking discussion in work groups.
5 pm
Prize draw and Happy hour

Our speakers are specialists in pharmaceutical cleaning validation with decades of industry experience.



Fred Ohsiek has performed cleaning validation for 22 years for small and large molecule API and finished-product manufacturing for 7 major pharmaceutical companies. This experience gave Fred a good perspective on industry best practices and practical solutions. read more …

His experience covers every stage of the CV life cycle – from cleaning optimization to cleaning validation to continued process verification.

His experience includes legacy and startup facilities. Therefore, he is experienced in defending, remediating, or optimizing legacy facilities or building a CV program from the ground up. Fred was one of the authors of the ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the CV acceptance criteria chapter lead.

In his current role with Ecolab Life Sciences, Fred conducts site surveys, and technical visits; solves cleaning problems; assists in optimizing cleaning processes; and coaches and conducts onsite CV training for the pharmaceutical and biopharma industry.



Dr. Rizwan Sharnez is a biotech, pharmaceutical and medical device consultant, and co-founder of BioSeparations Inc. and Cleaning Validation Solutions. He has over 30 years of technical and leadership experience in the development, validation, monitoring and life-cycle management of biopharmaceutical processes. read more …

His prominent clients include Alexion, Amgen, Agilent Technologies, AGC Biologics, Bristol-Myers Squibb, The Gates Foundation, Genentech, Genzyme, Merck, Patheon, Samsung Biologics, Seattle Genetics, Regeneron, Roche, Sanofi, Teva and ThermoFisher. Formerly, he was with Merck, Bristol-Myers Squibb and Amgen, where he served as Sc. Director until 2017.

Dr. Sharnez has authored over 100 scientific publications, patents and presentations and has led the development of several peer-reviewed industry whitepapers, guidelines, monographs and books on Cleaning Validation.



Vivek Gera is the CEO of Leucine, No-Code platform for compliant & audit-ready drug manufacturing. He brings a fresh data-driven outside-in perspective leveraging his 10+ years’ experience working on multiple high-value manufacturing automation products across regulated industries (Pharma, Medical Devices, and Mining). read more …

Vivek is a published author in multiple peer-reviewed journals and holds a master’s degree in chemical engineering.



Pete oversees all product direction for the food, beverage, personal care, nutraceutical, and bio-pharm industries. He received a Bachelor of Science degree in Chemical and Biological Engineering from the University of Wisconsin-Madison, leading him to engineering roles in product development, technical writing, and project management. read more …

More recently, Pete has moved into Product Management roles where he now manages the marketing, product development, and product management teams and activities for Sani-Matic systems, components, and services.

Pete continuously develops his hygienic design and process technical knowledge through participation in ASME Bioprocessing Equipment (BPE) Committee Meetings as a Systems Design (SD) committee member and task group leader, and 3-A Work Group Member Meetings. Pete is also a Preventive Controls Qualified Individual (PCQI) and is Hazard Analysis and Critical Control Points (HAACP) certified.

Rethinking Cleaning Validation Of Pharmaceutical Manufacturing Equipment Seminar. Register your attendance today

Register your attendance