Jerry Dalfors speaker of compliance global

15
Thursday
October, 2015

Speaker: Jerry Dalfors
Duration: 60 Minutes
Product ID: 700176

Purchase

CAPA Training and Causes of Warning Letters due to Lack of Comprehension

CAPA (Corrective and Preventative Actions) did not originate in the Pharmaceutical and Medical Device industry or the Automobile Industry as most folks post on the Internet.  The program to make effective corrections and ensure that preventative applications were incorporated was in use way back in the 60s by NASA and the FAA to enhance safety but was not labeled CAPA even though the intent was the same.

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 FDA.

“Proper” completion of the required forms in the “proper” order as described in the corporate directives and site procedures is what is required to remediate and prevent future observations by auditors and inspectors who have found numerous implementation issues  and execution as result of variances in overall comprehension (failure to establish and maintain an adequate CAPA program).  Examples are presented during the presentation.

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Jerry Dalfors speaker of compliance global

24
Monday
August, 2015

Speaker: Jerry Dalfors
Duration: 90 Minutes
Product ID: 700166

Purchase

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. The Medical Device Reporting (MDR) regulation (21 CRF 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.
Importers: Importers are required to report to the FDA and the manufacturer when they learn that one of their components that are used to produce or assemble the final device may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to reoccur.

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Jerry Dalfors speaker of compliance global

14
Thursday
May, 2015

Speaker: Jerry Dalfors
Duration: 90 Minutes
Product ID: 700072

Purchase

Mathematics of Terminal Sterilization - Survival 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. Some species (not necessarily spore formers) are highly radiation resistant.
The chemical environment causes significant variance in the death rate of a microorganism. Very dense cell walls, spore coats, or slime layers outside the cell can severely limit the ingress of what is being used to sterilize the product.

General principals used to kill microorganisms such as Steam and Dry Heat which causes denaturization of macromolecules, dissociation of tertiary and secondary structures, and protein agglutination along with destruction of molecular arrangements in the cells caused by radiation.  The generation of free radicals causes destruction and re-arrangement of chemical bonds in macromolecules.  Chemical disinfection or sterilization causes modifications of macromolecules depending on the agent used.

General Sterilization Terms
D value calculator – all types of sterilization
Z value calcuator – thermal sterilization processes
F-value – thermal sterilization processes that originated from 250oF
FBIO - thermal sterilization for specific organisms
Fo(F sub zero) – moist heat sterilization
FH(F sub H) – dry heat sterilization &depyrogenation
L – Lethality (aka F value) used in various processes

How do we calculate and monitor these different variables in order to generate the required SAL and PNSU based on the bio burden that may be contaminating the product from an API or the process?

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Jerry Dalfors speaker of compliance global

28
Tuesday
April, 2015

Speaker: Jerry Dalfors
Duration: 90 Minutes
Product ID: 700057

Purchase

PRINCIPLES, AND PRACTICAL ASPECTS OF LYOPHILIZATION TECHNOLOGY

Lyophilization, commonly referred to as freeze drying equipment, is the process of removing water from a product by sublimation and desorbtion.  This process is performed in lyophilization equipment which consists of a drying chamber with temperature controlled shelves, a condenser to trap water removed from the product, a cooling system to supply refrigerant to the shelves and condenser, and a vacuum system to reduce the pressure in the chamber and condenser to facilitate the drying process. Lyophilizers can be supplied in a wide variety of sizes and configurations and can be equipped with options that allow system controls to range from fully manual to completely automated.

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Jerry Dalfors speaker of compliance global

16
Thursday
April, 2015

Speaker: Jerry Dalfors
Duration: 90 Minutes
Product ID: 700048

Purchase

Process Validation in Statistical Process Control

The ultimate goal of FDA Process Validation is to ensure continual assurance that the process once initially validated (PQ now PPQ) and submitted for FDA/EU approval remains in a state of control by detecting unplanned departures from the initially proven acceptable process to meet Current Good Manufacturing Practice requirements using the collection and evaluation of data about the consistency of the process.  By conducting a specifically designed monitoring system and then as required by regulatory requirements that a statistician or person with adequate training in statistical process control to monitory, sample and analyze the quality attributes of each critical step of a process and also compare batch to batch consistency using the statistical analysis using the appropriate model.

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Jerry Dalfors speaker of compliance global

26
Thursday
March, 2015

Speaker: Jerry Dalfors
Duration: 90 Minutes
Product ID: 700029

Purchase

Generation of Controlled Documents and Related Training

The purpose of this webinar is to provide the topics and basic instructions needed to establish the good documentation practices training needed to meet or exceed compliance expectations expected by regulatory agencies (FDA/EPA and ISO) to generate and ensure objective and technically accurate data entry for quality related systems and production operations. Good Documentation Practice (GDP) is a term in the pharmaceutical industry to describe standards by which data entry and related documents are created and maintained. While not law, authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if compliance with GDP is not part of the company’s quality systems performance.

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Jerry Dalfors speaker of compliance global

05
Thursday
March, 2015

Speaker: Jerry Dalfors
Duration: 60 Minutes
Product ID: 700006

Purchase

CAPA Training and Causes of Warning Letters due to Lack of Comprehension

CAPA (Corrective and Preventative Actions) did not originate in the Pharmaceutical and Medical Device industry or the Automobile Industry as most folks post on the Internet.  The program to make effective corrections and ensure that preventative applications were incorporated was in use way back in the 60s by NASA and the FAA to enhance safety but was not labeled CAPA even though the intent was the same.

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 FDA.

“Proper” completion of the required forms in the “proper” order as described in the corporate directives and site procedures is what is required to remediate and prevent future observations by auditors and inspectors who have found numerous implementation issues  and execution as result of variances in overall comprehension (failure to establish and maintain an adequate CAPA program).  Examples are presented during the presentation

read more
Moving from an Operational Manager to a Strategic Leader

Speaker: Chris DeVany

Time: 01:00 PM EDT | 10:00 AM PDT
Location: New York

Logistics Channel Incoterms Standards

Speaker: Dr. Rossano V. Gerald

Time: 01:00 PM EDT | 10:00 AM PDT
Location: New York

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