This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.
Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impact to product and patient health and safety.
This course will also review…Continue
Posted on February 20, 2019 at 6:33am
The aim of this webinar is to provide an introductory overview of the requirements demanded by the FDA and EMA (arguably the two most important regulatory authorities for drug developers) for EIM (the IND and IMPD) and to provide an brief review of where the agencies differ as well the commonalities of approach for their EIM dossiers.
Although each regulatory authority publishes guidelines and instructions regarding the requirements for the Entry Into Man (EIM) of a new…Continue
Posted on February 18, 2019 at 5:20am
Preliminary risk assessment (e.g., Likelihood X Impact) and the results of previous audits (e.g., number of NCs) are often used to help prioritize the audit schedule. While these are worthwhile to consider, they do not necessarily reflect the real-time performance of the processes that could be included in the audit plan. This means many audits are likely investing time and human resources in looking at processes that are performing adequately, while others that might be at greater risk are…Continue
Posted on February 13, 2019 at 6:13am
Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Tax Evasion and Tax Fraud. What it means to you when monitoring BSA and filing SARs”.
Doug Keipper, a Certified Anti-Money Laundering Specialist (CAMS) and a former Bank Secrecy Act officer and compliance officer, will be the speaker at this webinar. Please visit…Continue
Posted on February 6, 2019 at 6:33am