Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency | Guidance for Industry - FDA.gov

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According to the guidance document:

"FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to describe how we will request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, or held; facilities covered under FDA's bioresearch monitoring (BIMO) program; and outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for the duration of the COVID-19 public health emergency.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2))."

View the full source document: Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry - FDA.gov (PDF)

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Be Careful What You Wish For: Specialized FDA Inspectors Don’t Necessarily Mean Happier Inspections - FDA Law Blog

Read the entire article: FDA Law Blog: Be Careful What You Wish For: Specialized FDA Inspectors Don’t Necessarily Mean Happier Inspections:

"Such specialized investigators may be more adept and knowledgeable at identifying issues, making for undoubtedly “smoother inspections” instead of flailing around.  But just because an inspection may be smoother, it does not mean that there will be happier consequences for the affected facilities."

'via Blog this'

#FDA #cGMP #GMP #training #courses #classes

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CA HMDR Facilities Must Have Policies and Procedures

• California HMDR Exemptee Training Certification Course (accepted by the California Department of Public Health - Food and Drug Branch) - Buy Now!

Updated July 6, 2021

Pricing – Standard Operating Procedures Course

• $100 per student when co-purchased with our California Exemptee training course.
• Select our Writing Standard Operating Procedures (SOP) Couse as an optional “add-on” course when you purchase our California HMDR Exemptee license training certification course. In other words, buy this course, then add the optional SOP course during registration.

---  the original post follows below  ---

Policies & Procedures Required For CA HMDR Facilities

The CA Home Medical Device Retailer (HMDR) licensing program is governed by law sections found in the California Sherman Food, Drug and Cosmetic Law. The Sherman Law was amended in the 1999-2000 legislative session to establish the HMDR licensing program. The applicable sections can be found in an abstract of the Sherman Law.

Section 111656.3 starts out with:

"Each home medical device retail facility shall have written policies and procedures related to home medical device handling and, if authorized by the department pursuant to Section 111656.4, the dispensing of prescription devices. Those written policies and procedures shall be adequate to assure compliance with this article and shall include, but not be limited to . . . "

Notice the phrase, " . . . shall have written policies and procedures . . . "

Not quite sure how to begin, and start writing them?

Then you might be interested in:
Buy Now: Writing Procedures: Drug and Device Wholesalers and HMDR 
 - an online training course from SkillsPlus International Inc.

Learn to write procedures quickly and thoroughly. Allan shares his experiences and techniques for writing procedures. This class is based on 30 years of experience writing procedures and teaching others to write them. This class is only for drug and device wholesalers, DME's and home medical device retailers. Pharmacists and pharmacy technicians responsible for procedures in their firm may also benefit. 

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Training program for California Home Medical Device Retailer (HMDR) Exemptee license applicants

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