Jerry Dalfors
Principal, JD Technologies
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 briefing 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 field 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.
Upcoming Webinar
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Recorded Webinar
Preparing a US FDA Medical Device 510(k) Submission and Deciding When to Submit a 510(k) for a Change to an Existing Device
This webinar ensures your company gets a broader perspective of how and what to do to get a quick and non-debatable or questionable approval for your 510K product. All are different so this presentation will not just be specific for a specified Medical Device that is currently being marketed and your company wants the same opportunity to produce and sell that product.
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Using Microsoft Excel to Ensure Accurate Analysis, Monitoring and Training to be within required FDA Compliance - Profitability
This webinar will give attendees a broader perspective of how to use Microsoft Excel program and how this system has proven to be very successful in gaining FDA approval when the field inspectors come in to do their job. This ensures that the facility is operating in a way that is very reliable and consistent in doing what is needed to minimize patient risk. Microsoft Excel can be used in a multitude of ways for a vast majority of the operations within the facility to prevent data modifications. It is also a tool that provides the inspector to get the objective evidence that this facility maintains the high quality standards to avoid product and procedural errors.
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Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach
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), the webinar 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.
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CMC & CTD Considerations for INDs/ANDA's/NDA's for 505(b)(2) Drug Products: Know The Ins And Outs Of 505(b)(2) Regulation And Guidance From The FDA
In this 90 minute webinar, Jerry Dalfors will highlight the key elements of the CMC section of an IND and NDA application for a 505(b)(2) product using examples and case studies. He will discuss the practical strategies for compiling the CMC sections of 505(b)(2) applications and also some key strategic considerations using real-life case studies. Plus, he'll shed light on the role of Drug Master Files (DMFs), and cross reference authorizations.
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Format for Making Regulatory Submissions to Ensure a Quicker Approval
This discussion is intended to describe how to organize new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biological license applications (BLAs) based on the FDA expectations to approve the submission.
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Quality Agreements and Annual Inspections
This webinar will discuss how parties involved in purchasing critical raw materials can generate patient risk and when the contract manufacturing of drugs have to utilize quality agreements to assure drug quality, safety, and efficacy.
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Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach
Different microorganisms in different environments during sterilization have different resistance to the destructive principles that causes the organism or spore to die (lethality). Some extreme thermophile organisms have their optimal growth temperature at 110°C, whereas most vegetative cells are killed at 60°C.
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Lyophilization Technology
Lyophilization cycles consist of three phases: Freezing, primary drying, and secondary drying. Conditions in the dryer are varied through the cycle to ensure that the resulting product has the desired physical and chemical properties and that the required stability and sterility is achieved and maintained.
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Process Validation - Statistical Process Control
Process knowledge and understanding is the basis for establishing an approach to process control and related instruction sets in the Batch Record for each critical step of the process operation and process results. Strategies for process control and operator activities can be designed to reduce variation, adjust to variation during manufacturing and reduced possibility for operator error.
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Batch Production Record and Device History Record Review and Quality Assessment
Written procedures are to be established and followed for a time efficient and clear evidence of the quality related elements during the review and approval for release, including packaging and labeling, to determine compliance of the intermediates (FDA definition) and/or finished product with established specifications before a batch can be released for distribution.
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Medical Device Reporting (MDR)
Manufacturers of Medical Devices are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction was to be reoccur.
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Generation of Controlled Documents and Related Training
This presentation is intended to provide the needed documentation practices associated with documentation creation, document approval, handwritten entries, copies of documents, document maintenance and document modification.
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CAPA Training and Causes of Warning Letters due to Lack of Comprehension
A timely, well documented, Corrective / Preventive Action program validates a quality system that is not only capable of identifying potential problems but also effectively correcting problems when incidents do occur and as part of the Continuous Quality Improvement program, correcting potential problems prior to occurrence. Adequate incident tracking is the primary foundational element for an effective CAPA system.
Recorded Session Get life time access for one participant with download option!

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