The pharmaceutical industry has been on the leading edge of anticounterfeiting and brand protection efforts for many years. “Anticounterfeit solutions are usually tailor-made according to the needs of the brand owner,” says Paavo Sillanpää, senior business manager, Pharma at UPM Raflatac.
A diverse strategy considering threat scenario and product is needed. “Most pharma companies have a multi-layered approach,” notes Farrell. The most common physical solutions are tamper-evident labels and packaging materials, designs that prevent the placement of a counterfeit product into the original packaging, serialization, and overt and covert authentication methods such as holograms, invisible markers, and taggants. “Ideally, multi-level security concepts should be used that are individually tailored to a specific use case, combining analog and digital features, which can be verified by different stakeholders within the supply chain,” says Dul.”
This online training certification course satisfies application requirements for anyone applying for an Exemptee License through the California Department of Public Health (Food and Drug Branch) and is responsible for overseeing prescription devices including business owners, chief executive officers, general managers and compliance officers. For the home medical device retail (HMDR) industry.
California HMDR Exemptee Training
If you are applying for a California Exemptee license, you’ll need to include proof of required training in your license application. Take this online course to earn a course completion certificate for your license application.
Accepted by the California Department of Public Health (CDPH) – Food and Drug Branch
Earns a CDPH-recognized course completion certificate
Online training classroom available 24 x 7
Nearly 7,000 students have taken our state license-related courses
The longest continuously offered class for HMDR Exemptee license applicants
California HMDR Exemptee Online Training Certification Class
“The Drug Quality and Security Act (DQSA) was signed into law almost seven years ago on Nov. 27, 2013. Title II of this Act, known as the Drug Supply Chain Security Act (DSCSA), …
… initial requirements of the DSCSA, introduced in a phased manner, were deliberately structured and timed to allow industry to thoughtfully design and implement the required capabilities in preparation for the pinnacle requirement, which goes into effect on Nov. 27, 2023: the implementation of Enhanced Drug Distribution Security (EDDS) capabilities. EDDS will be enabled by the establishment of standards for the interoperable exchange of data, combined with the inclusion of individual serial numbers in the product shipment transaction information transmitted for the NDCs/Lot #s sold and distributed. …
There is little doubt that the prescription drug product traceability and reporting requirements at the individual, serialized unit-level will require considerable planning, assessment, decision-making, change control, and execution. Manufacturers need to proceed quickly but thoughtfully and should approach this upcoming era of serialized product traceability holistically by expanding their objectives beyond achieving and maintaining compliance.”
Question: What kind of work experience is accepted for a California Designated Representative license?
The California Designated Representative Experience Affidavit specifies what kinds of work experience will be recognized and accepted. Pay close attention to some of the operative words and phrases that are used, such as:
paid work experience
minimum of one year experience
one year of paid work experience in the past three years
in a licensed facility
Some of the experience requirements are different, depending upon your selected personal license. Therefore, be sure to reference the personal license application you’re applying for (wholesaler; 3PL; reverse distributor) in the experience affidavit form/section.