pharmaphorum

OCTOBER 27, 2022

Webinars – Webinars, whether live streamed or on-demand, can be used for communication with HCPs, HCOs, and POs. A company is responsible for the content of webinars and should take reasonable steps to ensure the audience is targeted and well defined.

Communication 98

Communication Packaging Documentation Pharmaceutical Companies 98

Omnicell

JANUARY 10, 2023

Hospitals are already using Fresenius Kabi Simplist® MicroVault® prefilled syringes to help nurses spend less time preparing doses and documenting waste. The new cassettes for the Omnicell CSD will accommodate MicroVault® packaging for a variety of low-dose narcotic medications, including morphine, hydromorphone, and fentanyl.

Controlled Substances 40

Controlled Substances Omnicell Hospitals Packaging 40

Pharmaceutical Technology

SEPTEMBER 26, 2022

Requirements on imports, packaging, storage and circulation of medical products and devices have been eased, while continuing to uphold product requirements for efficacy and patient safety. CROs and sponsors use remote source document verification, as approved by the regulator pre-war.

Packaging 52

Packaging Documentation 52

DiversifyRx

JULY 11, 2024

Join our next Awesome Webinar Series with guest legal guru JD from Real Value Rx to answer any questions you have about the DSCSA delay. To be authorized: Pharmacies should ensure they receive, maintain, and update these documents as necessary to continue ordering from their ATP and be ready to provide copies of them upon request.

Independent Pharmacies 52

Independent Pharmacies FDA Documentation CPhT 52

Pharmaceutical Technology

DECEMBER 13, 2022

Secondary drying removes adsorbed residual moisture until the target value is achieved, at which point the material is secured in a moisture-free package. Mass spectrometers enable complete documentation of the freeze drying process. Most of the moisture is removed during the primary drying stage. Process gas monitoring.

Packaging 52

Packaging Documentation 52

PQA

JUNE 27, 2024

Pilot participants were provided a technical package containing all resources needed to accurately calculate the SP-TAT-PH measure. This feedback was gathered via surveys and then further discussed by pilot participants during three collaborative webinars. Sufficient staffing enabled specialty pharmacies to take on new tasks (e.g.,

Specialty Pharmacies 40

Specialty Pharmacies Communication Packaging Documentation 40

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., 16 Health Canada.

Documentation 52

Documentation FDA Communication Packaging 52