Legacy Cleaning Validation Concerns and The Solution
April 29, 2022
Legacy Cleaning Validation Concerns and The Solution

 SAE Media Group’s 5th Annual Conference
Pharmaceutical Microbiology East Coast
April 27-28 2022 | Boston, US
Microbiology remains an essential tool in reducing microbial growth in the manufacture of pharmaceuticals, to detect and eliminate microorganisms that would pose a risk to patients and jeopardise product batches.

Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors are also sustaining new growth and transformation in this field. The regulatory landscape is changing, firstly with the preparation of Annex I, in addition to increasing requirements pertaining to data integrity. Light is being shed on recent product recalls for mould contamination, and infection outbreaks serve as a reminder to pay more attention to these overlooked organisms, as well as considerations towards container closure integrity testing which is being increasingly deployed to block microbe movement.


Cleaning procedure and validation are essential components of the pharmaceutical manufacturing process that prevent cross contamination and issues with compliance – ultimately protecting the safety of patients. In this workshop we will walk through robust risk-based approaches to cleaning monitoring, and Continued Process Verification.

This workshop will address the following topics:

  • Quick review of regulatory guidelines for maintaining the validated state 
  • Legacy cleaning validation concerns and pitfalls
  • Explore the benefits for re-validating legacy cleaning processes 
  • Tour and examine the re-validation process



Fred Ohsiek

Fred Ohsiek

Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk

Fred Ohsiek

Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk
Fred Ohsiek

Fred Ohsiek is the Sr Cleaning Validation Specialist for Novo Nordisk in Clayton, NC. He earned his Bachelor in Chemistry from University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 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.
His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring cleaning processes for equipment used to manufacture small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional products. The scope of his work involved drug substance and drug product manufacturing start-up, remediation, legacy justification, and increasing manufacturing capability. He has created lean CV strategies for document structure/flow and execution in every aspect of the cleaning validation process.
He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.


Workshop agenda



Registration & Coffee



Opening Remarks

Fred Ohsiek, Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk



Session 1

Fred Ohsiek, Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk

  • Quick review of regulatory requirements and guidelines 
  • Initial cleaning validation risk assessment
  • Building the CV program using the risk assessment
  • clock


    Session 2

    Fred Ohsiek, Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk

  • Stage 1 cleaning validation documents
  • Stage 2 cleaning validation documents
  • Essential cleaning validation documents
  • Lean CV protocols and execution
  • clock


    Morning Coffee



    Session 3

    Fred Ohsiek, Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk

  • Quick review of FDA 2011 Continued Process Verification (CPV) regulatory guidelines
  • In-depth discussion on periodic review, CPV, and dated validation packages
  • Risk-Based approaches to Continued Process Verification
  • Reducing routine monitoring frequency
  • clock


    Session 4

    Fred Ohsiek, Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk

  • Case study for determining CPV frequency and testing and then reducing frequency
  • Case study for re-validating legacy cleaning processes
  • clock


    Closing remarks

    Fred Ohsiek, Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk

    Sr Validation Manager instead of Sr Global Technical Manager
    Novo Nordisk

    Sheraton Boston Hotel

    39 Dalton Street
    Boston 02199

    Sheraton Boston Hotel

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.



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    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.


    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.


    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.


    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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    Opening Hours: 9.00 - 17.30 (local time)
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