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Jerry Dalfors

Jerry Dalfors is Keynote Speaker at Compliance key Inc.He 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 an 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 as well as reducing costs to make companies more profitable.


 Webinar Id: LSHCJL004
 6 months unlimited
 Duration 60 mins

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. During the freezing phase, the goal is to freeze the mobile water of the product. Significant supercooling may be encountered, so th........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJB002
 6 months unlimited
 Duration 60 mins

Batch Production Record and Device History Record Review and Quality Assessment to ensure compliance with DMF and DMR specifications

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 BPRs, DHRs and laboratory control records for critical process steps a........

$167 Recorded (6 months unlimited access)
 Webinar Id: HCLS010
 6 months unlimited
 Duration 90 mins

CGMP Application for Design & Operation

GMP was established back in the 60's and 70's to help Drug and Medical Device companies set up systems and related employee activities to help minimize patient risks.cGMP (current Good Manufacturing Practices needed to minimize patient risk and increase the probability of profitability) regulations require a quality related operations system that establishes and maintains a manufacturing system and related monitoring and testing specifi........

$167 Recorded (6 months unlimited access)


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