Showing 1-15 of 31 items.

If an employee has suffered a work-related injury that resulted in the loss of sight but the physical eye was still in the socket, would that require a call to OSHA informing the duty officer of the incident?

Irwin Dobrushin, a Certified Industrial Hygienist, answered: No, loss of sight without the physical removal of the eye is not a reportable event under the requirements in Section 1904.39. However, a case involving loss of sight that results in the in-patient hospitalization of th 

Does FDA permit the marketing and sale of an OTC Cough / Cold Drug Product containing a combination of the 3 following active ingredients: Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride and Pectin?

Food and drug regulatory attorney Karl M. Nobert answered: Yes. A Cough / Cold OTC Drug containing such a combination can be legally marketed and sold in the U.S. without  risk of FDA enforcement action, so long as it is done in compliance with FDA’s OTC drug regulations a 

How should railroads handle OSHA regulations since they fall under the FRA? Would they just show the FRA required forms and logs if/when an OSHA inspector shows up?

Environmental Health and Safety Consultant Kenneth S. Weinberg answered: OSHA regulations do not supersede the Injury and Illness Reporting Requirements under the Federal Railroad Administration (FRA). Therefore, the FRA rules apply here for reporting injuries and illnesses.

 

We have heard that approvals in Latin America are based on Tier I, reference country approvals elsewhere. Is this true?

Robert J. Russell, a specialist in global regulatory issues for the pharmaceutical industry, answered: Yes, however each country is different in their interpretation of who they consider to be a Tier I Healthcare Authority. They will almost always want to see an approval from the 

If the FMLA only gives job protection for a leave up to 12 weeks in a 12 month period, why can’t I terminate employees when they do not return from leave at the end of 12 weeks?

Labor & Employment Law expert Susan Fahey Desmond answered: The FMLA requires an employer to give up to 12 weeks in a 12 month period for a serious health condition – even if it is burdensome to do so. The ADA, however, does not have a “12 week” period written into it,  

Do you recommend performing software validation on processes in which the desired outcome is sufficiently verified, even if those processes do include software?

Quality Assurance consultant Dev Raheja answered: I recommend performing software validation on processes in which the desired outcome is sufficiently verified, even if those processes do include software. Validation requires objective evidence that it works correctly in actual c 

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