Generic placeholder image

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: LSHCJDM004
12:30PM PT | 03:30PM ET
 02/28/2018
 Duration 60 mins

Maintaining a Validated State - PV, PM and Statistics associated with Current Regulation

Statistical Applications - Use of a statistician or person with adequate statistical training (not just 6 Sigma) to develop the experimental design and the statistical methods /models needed to measure and evaluate process capability, uniformity and on-going stability. Generate A Sense of Control - Process design and development, when assessed by the statistician, should anticipate significant sources of variability and establish statis........


View Details

                $179
       Single Attendee
(Only for one Participant)
          $363
Multiple Attendee
( 2 - 5 Participants)
          $726
Corporate Attendee
( 6 - 10 Participants)
                   $237
         Recorded
(6 months unlimited access)
 Webinar Id: LSHCJL004
12:30PM PT | 03:30PM ET
 03/15/2018
 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........


View Details

                $179
       Single Attendee
(Only for one Participant)
          $363
Multiple Attendee
( 2 - 5 Participants)
          $726
Corporate Attendee
( 6 - 10 Participants)
                   $237
         Recorded
(6 months unlimited access)
 Webinar Id: LSHCJR003
12:30PM PT | 03:30PM ET
 03/30/2018
 Duration 60 mins

Regulatory Submissions all Part of 510K

Ensuring 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 lots different so this presentation will not just be specific for a specified Medical Device that is currently being marketed and your company want the same opportunity to produce and sell that product.


View Details

                $179
       Single Attendee
(Only for one Participant)
          $363
Multiple Attendee
( 2 - 5 Participants)
          $726
Corporate Attendee
( 6 - 10 Participants)
                   $237
         Recorded
(6 months unlimited access)
 Webinar Id: LSHCJD001
 View Anytime
 Duration 90 mins

Mathematics of Terminal Sterilization - Probability of Survival Approach vs Overkill Approach

Heat sterilization is a PROBABILTY function dependent on heat exposure, the number of microorganisms, and the heat resistance of the microorganisms. Current regulations expect the sterilization process to provide a level of assurance of at least 1 x 10-6 probability (fewer than one non-sterile unit per million units) of survival (non-sterility) for terminally sterilized parenterals and medical devices. Since Regulations require that we ........

$237 Recorded (6 months unlimited access)
 Webinar Id: LSHCJB002
 View Anytime
 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........

$237 Recorded (6 months unlimited access)
 Webinar Id: HCLS010
 View Anytime
 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........

$237 Recorded (6 months unlimited access)


    
Copyright © 2017 Compliance Key . All Rights Reserved. Back to Top