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Determining best way to work with Microorganisms to ensure we have sterilization that verifies we have no patient risk or product stability issues due to survival of the microorganism or damage to the product due to sterilization. Since there is so much different interpretation of regulatory statements and because different agencies have different philosophies, those who do not have a deep comprehension of the sterilization design relative to the microbiological impact (why many sterilizers have been improperly designed), we will discuss the definition of “Sterile” and how to get there by describing different sterilization methods, various approaches to be used for the validation of a sterilization process using moist heat as template that can be used for other sterilization methods and what requirements for routine monitoring and control of sterilization are required.


Knowing how to most effectively establish your D-values, Z-values, F-values and Fbio-values along with Fo, FH and lethality based on your bioburdens and any biological indicator you select to use in your process based on the variables associated with so many different issues associated with different products that all need to be proven to be sterile prior to distribution.

Beginners, Intermediate and Advanced Development and Validation individuals attempting to demonstrate consistent validation to achieve a significant cost reduction and minimal patient risk

Workshop LEADER


Jerry Dalfors

BioPharmaceutical Technical and Compliance Consultant, Author and Life Coach, JD Technologies, LLC

Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company
representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US. He has worked with or assisted more than two dozen
companies with the establishment of controlled document/quality systems, FDA briefi ng and submittal documents, project management of several multimillion dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training. Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered and expert in most all aspects of the biopharmaceutical and medical device industry and has trained many FDA fi eld inspectors on a variety of topics. None of his work has ever received a 483 but has corrected and prevented many along with Warning Letter remediation.

JD Technologies, LLC


JD Technologies provides consulting, regulatory and documentation support to the pharmaceutical and
biopharmaceutical industries. JD Technologies prides itself on being able to successfully carry a project from concept to completion, and integrating with other company employees and contractors in a team effort.

Workshop programme

13:30 Registration & Coffee

14:00 PNSU – BIOBURDEN – Probability Function D values, Z values and Fo

Jerry Dalfors

Jerry Dalfors, BioPharmaceutical Technical and Compliance Consultant, Author and Life Coach, JD Technologies, LLC
View Bio

• How were those established?
• Where Did “Fo” start relative the microbial impact
• Microbiological D value variations
• Can’t typically use what the vendor provides for D values and Z values based on your product trying to be sterilized.
• Typical BI Death Curve and Fraction Negative
• D121 value, Z value and Determination of Fo
• Bioburden Monitoring and determination of potential sterilization risk compared to any biological indicator

15:30 Afternoon Tea

16:00 Recent FDA Sterilization Observations

Jerry Dalfors

Jerry Dalfors, BioPharmaceutical Technical and Compliance Consultant, Author and Life Coach, JD Technologies, LLC
View Bio

Recent FDA Sterilization Observations Resulting in Warning Letters – Providing what the FDA has written about a variety of different situations that
has caused signifi cant concerns based on many companies not having the correct perspective about Microbiological Sterilization.

17:00 Chairman’s Closing Remarks and Close of Day One

17:20 Closing remarks

Jerry Dalfors

Jerry Dalfors, BioPharmaceutical Technical and Compliance Consultant, Author and Life Coach, JD Technologies, LLC
View Bio

17:30 End of workshop


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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, SMI 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@smi-online.co.uk

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