https://www.rockwellautomation.com/en-us/company/events/in-person-events/automation-fair.html

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Everyone involved is scrambling to adjust to the new challenges that have come with the pandemic.

Below you’ll find some specific advice.

Post-COVID-19 Job Search: What’s Changing

Social Media Is More Important Than Ever

According to research by Jobvite, cited by Scott Steinberg in a CNBC article:

“84% of recruiters are currently adapting their hiring processes to facilitate remote exchanges. Of them, 58% are now using social media networks like LinkedIn, Facebook, and even Instagram to connect with potential hires, while nearly half are increasing the number of postings that they make on these services to advertise open positions.

A growing army of recruiters are likewise turning to videoconferencing solutions to screen and interview candidates as well, with as many as 8 in 10 now making it a key part of the hiring process. Digital communications tools such as artificially intelligent job outreach programs and text messaging are also increasingly being implemented as a means of connecting with candidates. But 55% of recruiters are also falling back on phone calls to source potential hires.”

Here are 4 LinkedIn things you should be doing to keep your personal brand top-of-mind:

• Posting updates regularly
• Uploading videos to your updates and adding videos to your profile
• Updating the content in your profile regularly
• Staying active with LinkedIn Groups

Video Conferencing and Video Interviewing are the THING!

Tech columnist for USA TODAY Jefferson Graham says that, just like in in-person meetings, “for video meetings, the eyes have it.”

People often are not aware of how poorly they come across:

“We think we’re making eye contact in a video meeting because we’re looking at the faces on our screens and responding accordingly. But the camera isn’t on the screen, it’s usually above it, and sometimes even below.

Neither is flattering, and the bottom approach, seen on some laptops, is about as unflattering as they come. Laptop magazine referred to the camera on some of these models as a “nose cam,” Horror film directors have used the technique in films like “Frankenstein” and “Dracula” to scare the “yell” out of you.”

To overcome this predicament, videographer Larry Becker notes in the article what he does to stay focused correctly:

“He makes a small sticky note with the topics he wants to cover from the call and pastes it right atop the webcam. He makes sure that it’s a small sticky note, ‘so I’m not breaking eye contact and obviously looking away. ‘The bigger the sticky note, the more obvious it is you’re looking away.’”

Job Interviewing Looks and Works Differently

As noted above, you’ll need to prepare for video interviewing and learn best practices.

Not only will you need to prepare to answer the traditional interview questions, and know what questions YOU should ask. You’ll also need good answers to the workplace challenges COVID 19 has brought.

Career coach Barbara Schultz suggests that you position yourself in interviews as someone who can help the employer solve some of the problems associated with the pandemic.

Here are some job interview questions she says you can expect to be asked now:

• Have you ever worked remotely? If so, what changes did you make to adapt to an at-home work environment?
• What aspects about working from home did you enjoy, and which did you find most challenging?
• When working remotely, how do you organize your day?
• What ways would you communicate with your manager and co-workers in a remote setting?
• What are your thoughts on how our teams can collaborate? And how can we interact with clients safely once we return to work?
• How have you handled the stress of Coronavirus?
• What would you personally do to maintain safety in the workplace?
• What life lessons have you learned during the pandemic?
• Will you be willing to work in an office again when/if working remotely is no longer required?

Interview Questions to Be Careful Answering

An article on Career Contessa warned that some interviewers may fish for personal information they’re not entitled to by asking questions that tiptoe on the line of legality, such as:

• How is home life during the pandemic?
• Where is your home office located?
• What does your home life look like right now?
• Do you have any childcare or caretaking needs?
• Are you overly concerned about your own health?

Post Corona Job Search Tips for 50 Somethings

In an article with tips for 50+ job seekers, career coach Dorothy Dalton put it plainly:

“One of the most vulnerable groups in this, or any other, recession is the 50 somethings . . . they are simply more expensive than junior employees. Severing a few senior execs or older employees can make an instant and positive impact on any organisation’s salary bill. Additionally, at this level employees are also costly in terms of perks and benefits, with company cars, phones, laptops, health and pension plans and longer holidays etc, all contributing to reducing a company’s overheads when they no longer work for the organisation.”

She detailed a number of things 50+ job seekers should consider:

• Get emotional support
• Set up coping strategies
• Take stock
• Update your resume
• Identify your transferable skills
• Update/upgrade your professional skills
• Take interim assignments
• Tap into your network
• Get comfortable with social media
• Assess your physical image
• Stay fit and healthy
• Prepare for the new kind of interviews
• Be willing to relocate
• Do some volunteer work
• Become an expert
• Determine whether self-employment is right for you
• Be willing to change tactics

You Need to Become Relevant Again

We all know how much the pandemic has disrupted so many aspects of our personal lives. It’s also disrupted businesses and industries.

The better you position yourself as someone who is prepared to help your target companies thrive through disruption, the more valuable you’ll appear to them. Begin by identifying the particular disruption impacting them.

Marc Miller of Career Pivot put it this way:

At Automated Systems, we have a team of recruiters to guide you during the challenges of interviewing.   If a position on our Careers Page interests you, don’t hesitate to reach out and apply.  Our team of experts will work with you every step of the way through our job placement process.

References: Executive Career Brand, 2021, Meg Guiseppi, Accessed July 20, 2021, www.unsw.edu

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With the US, European, and Russian pharmaceutical serialization deadlines looming, the industry is busy implementing these new technologies to their production lines

Serialization, in effect, expands the digital dimension to production data. Instead of just master and batch data, there will be individual package-related data in cloud and ERP systems. Even the small-scale production sites that have been able to rely on paper-based reporting have to adopt digital reporting.

Of obvious importance is the need to reconcile data, not just materials, after the production run before the batch is released. The approved batch should not have serial numbers hanging loose, nor packages without serial numbers, nor serialized packages not accounted for. All the rejected packages with serial numbers must be accounted for.

Digital accounting makes the control of data integrity both easier and harder. On the other hand, the data systems can be made to provide an audit trail for every data read, write, and change, require digital identification of persons responsible and provide backups. On the other hand, people are prone to looking for shortcuts, especially during incidents. For example, if the person having the access rights to production line stop mitigation is not always close, the personnel may find a shortcut, e.g., having access keys are available at the production line to make quick changes and repairs. This results in obvious data integrity risks.

Data integrity might look like a simple issue with a modern computerized production control systems, but it is hardly so. There are interfaces between the systems: within the organization, between trading parties such as API manufacturers or CMOs and MAHs, and between the MAHs and cloud systems or government repositories, such as the European Hub in the EMVS, and MDLP in Russia.

Each data transfer contains the possibility of unintentional data changes. Guaranteeing the data integrity between ISA levels 2 (production line) and 3 (site/factory level) may well be troublesome if the software solutions on these levels are from different vendors. An example of an unintentional change of data was with HIV testing at a blood service years ago, where the transferred testing data was truncated and critical information lost — leading to people getting contaminated blood.

Compromising data integrity compromises also patient safety.

To meet regulatory expectations, data must be attributable, legible, contemporaneous, original, and accurate: “ALCOA,” a term already familiar to those involved with clinical trials (as well as those in the aluminum industry). Furthermore, data must meet the applicable requirements of GMP, GLP, GCP, QSRs, and ERES regulation such as 21 CFR Part 11.

Regulatory agencies have increased industry oversight regarding data integrity. The FDA, noting many Warning Letter and 483 observations, produced a draft guidance on the subject in 2016. FDA published the finalized guidance in December 2018. EMA, WHO, and PIC/S have also published recent guidances on data integrity.

Automated Systems, Inc. can provide your firm with experienced resources to help you learn your level of compliance with current regulations, and determine appropriate and efficient courses of action. We can provide you with:

A gap analysis, which identifies:

The regulations, guidance, and industry standards that apply to your products

Your present level of compliance

A prioritized, risk-based course of action for remediation and improvement

Training on data integrity topics

Policy and SOP development

System configuration advice

Computer System Validation

Automation

Responses to regulatory agency observations

For 30 years, Automated Systems, Inc. has provided our life science community with solutions to data integrity problems. Please contact us to learn more about how we can customize our services and expertise to assist you.

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Automated Systems Inc. is proud to sponsor the upcoming networking event hosted by the ISPE Great Lakes Chapter at Mickey Finn’s bar and restaurant on Thursday, September 16, 2021 from 5:00 to 7:00 pm.  To join the festivities, you can sign up here.  Hope to see you there!

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In this first part of this 3 part series, we will address how the FDA can respond to inspections.

How the FDA Can Respond to Inspections

When the FDA begins an inspection, they may for a variety of reasons, such as Pre-approval Inspections, Post-Approval Inspections, Surveillance inspections and For-cause inspections. Form 482 “Notice of Inspection” will be presented upon arriving at your plant. The 482 explains the Agency’s inspectional authority and provides expectations for the Inspector and the firm.  It will also outline contact information in the event a 483 response is issued.

Inspections vary by type of product and the size and complexity of the facility.  For example, in a drug manufacturing facility inspection, the FDA will often examine six systems – Quality, production, facilities and equipment, laboratory controls, materials and packaging and labeling.  In a food inspection, FDA will determine whether a firm has compiled with the appropriate preventative controls described in the regulations.  In device inspections, FDA focuses largely on compliance with Quality Systems Regulation.  As with all of the above inspections, the investigators will examine relevant records and processes, such as Standard Operating Procedures, laboratory test results, training records and whether employees follow procedures, and whether a firm is appropriately sterile and clean.

At the conclusion of the inspection, the investigator will issue a form entitled “Inspectional Observations”, or Form 483.  It will list observations made by the FDA representative(s) during the inspection. These observations do not represent a final agency determination regarding compliance. The 483 formally notifies the organization’s top management of objectionable conditions or practices relating to violations of the Federal Food, Drug, and Cosmetic (FD&C) Act that were observed during the inspection.

If the inspection does not yield any objectionable conditions or practices, a 483 will not be issued. However, if the FDA representative(s) does observe objectionable conditions, one or more 483’s will be issued during the closing meeting. If the agency does issue one or more 483’s at the conclusion of the inspection, it is always better to select “promise to correct” in response to each 483 observation.

Depending on the nature of the violation(s), the FDA may give the firm an opportunity to take voluntary and prompt action to correct the violation(s) before the agency initiates an enforcement action. However, the FDA generally is under no legal obligation to warn individuals or firms about violations before taking additional enforcement actions, as further described below.

The FDA uses untitled letters for violations that are not as significant as those that prompt warning letters. Unlike a warning letter, an untitled letter does not include a statement warning that failure to promptly correct a violation may result in an enforcement action.

Warning letters, on the other hand, are issued to manufacturers or other organizations that have violated some rule in a federally regulated activity, i.e., violations of regulatory significance. A warning letter is one of the agency’s primary means of achieving prompt voluntary compliance with the FD&C Act.

Injunctions may also be ordered to halt the flow of violative products and to correct the conditions that caused a violation to occur. An injunction is a type of judicial action that is considered for any significant out-of-compliance circumstance, but particularly when a health hazard has been identified. When an injunction is granted by a court, the FDA has a duty to monitor the injunction and to advise the court if the firm fails to follow through on its obligations. The three most common types of injunctions are the temporary restraining order, the preliminary injunction, and the permanent injunction.

The FDA may recommend a temporary restraining order when it believes that a serious violation has occurred, and the situation must be controlled, or the flow of product stopped immediately. A motion for preliminary injunction is subject to a full hearing before a court. Once the motion is granted, the preliminary injunction is in effect and may stand indefinitely until the case is settled or a permanent injunction has been entered, after trial.

A decree of permanent injunction may be entered at any time after the complaint is filed, either after a hearing or as a result of a negotiated settlement between the government and the defendant. A consent decree is a court-ordered agreement between the FDA and a firm that outlines the steps the firm needs to take to resume normal operations. Although each situation is unique, consent decrees often indicate necessary changes within the organization — and may even require the firm to involve outside consultants to oversee the changes and ensure ongoing compliance.

A product seizure is a judicial (court-approved) action for removing violative products from the marketplace. Product seizures typically are initiated when the firm has not voluntarily recalled product that the regulatory agency believes is in violation of the law and where there is a perceived or known health risk to the public.

After the inspection, and dependent upon the firm’s response to any 483 findings that are issued, the agency classifies the inspection with one of three statuses in the establishment inspection report (EIR):

• No action indicated (NAI) means no objectionable conditions or practices were found during the inspection (or the objectionable conditions found do not justify further regulatory action).
• Voluntary action indicated (VAI) means objectionable conditions or practices were found, and the firm’s response was satisfactory, so the agency is not prepared to take or recommend any administrative or regulatory action.
• Official action indicated (OAI) means objectionable conditions or practices were found, and/or the firm’s response was not satisfactory, so regulatory and/or administrative actions will be recommended.

In the second part of this 3 part series, we will continue the discussion on How to Respond to the FDA.

Understand that a warning letter or FDA 483 does not signal the end of your product, your job, or your company.  There are clear procedures to follow to overcome this hurdle.  We’ve helped pharmaceutical, diagnostic and medical device companies of all sizes resolve serious regulatory compliance problems. If you’re in need of help, contact our team of experts today.

References:

Sihorwala, Zoher. “What an EIR Entails and What It Means for Drug Makers.” The Hindu.Co.in.Com, 9 Jan. 2018, www.thehindubusinessline.com/specials/pulse/what-an-eir-entails-and-what-it-means-for-drug-makers/article9802971.ece.

“Issuance of Untitled Letters.” Www.Fda.Gov, FDA, www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/issuance-untitled-letters. Accessed 27 July 2021.

“What Should I Expect During an Inspection?” FDA.GOV, FDA, www.fda.gov/industry/fda-basics-industry/what-should-i-expect-during-inspection. Accessed 27 July 2021.

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The challenge of providing visualization and remote control of production processes has been addressed by various means through the years as technology has evolved.  Some automation vendors developed solutions based on ActiveX or Adobe Flash rendering of Human-Machine Interface (HMI) screens, while others delivered Remote Desktop Services (RDS) based connections and visualization of the production process.  While these solutions do enable broader access to plant floor systems, they rely on proprietary and custom software solutions to be installed and supported on the clients’ computers.

Since the first public draft of HTML5 in 2008, developers and designers have been finding ways to create HTML5-based HMI applications. The October 2014 release of HTML5 standards, which included native support and handling of multimedia and graphical content, was a game changer for developers.   With the new <video>, <audio> and <canvas> elements added, as well as support for scalable vector graphic (SVG) content, developers are able to create rich animated HMI graphic applications that are on par with legacy HMI solutions.

Applications written in HTML5 are platform independent.  They natively support iOS, Android, Windows and other platforms, as opposed to traditional solutions developed for specific computer systems.  As a result, HTML5 provides a cross-platform approach for automation control and reporting solutions, offering industrial users the same flexibility and benefits they’ve come to expect from mainstream business applications.

Different approaches for delivering HTML5 content:

GE Proficy Webspace extends the iFIX or CIMPLICITY application’s viewing and control abilities into a Web browser

Some automation software providers, including Wonderware, InduSoft, GE and Rockwell introduced HTML5-based Web Clients to their legacy HMI applications, empowering users to access selected graphic screens from the traditionally developed HMI application via a web browser.  While the HMI application is created using the legacy HMI development platform, the graphic screens are also deliverable via web browser connection, expanding user choices to access these applications.

On the other hand, Open Automation Software, Backhoff and Inductive Automation were among the first to introduce HMI applications built from the ground up, based on HTML5 standards.  These visualization tools deliver ease of developing mobile and desktop display screens, using the power of HTML5, CSS, JavaScript, jQuery and JSON.  By utilizing these standard platform-independent technologies, developers can create innovative HMI content or integrate HMI functionality into existing web applications with minimal effort.

Benefits of HTML5-based HMI applications:

Ignition HMI software’s responsive layout automatically adjusts the screen’s content to the client device resolution.

HTML5- or web-based Human-Machine Interface applications offer the benefit of displaying and controlling production processes on less expensive hardware options, in comparison to traditional HMIs, which require high-end Windows workstations. From the same computing platform, users can access plant floor as well as business systems.  Since the application is hosted on a centralized server, the ongoing maintenance, support and deployment of new releases requires less effort. Changes are made on a centralized server, and users of the application automatically receive the newest updates.

Another benefit of HTML5-based HMI is the ability to develop more intuitive and responsive applications that properly render to all client devices.  These applications automatically adjust the graphic screen’s layout to match the client device resolution.  They deliver the same content whether on a smartphone, tablet or high-resolution computer monitor.

In conclusion:

Both traditional and HTML5-based HMIs provide specific value and benefits.  With everchanging technology, our role as System Integrators is to educate our clients regarding the latest technology offerings, and help them make informed decisions on the best HMI development platform for their application needs.

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The current public focus on personal hygiene and cleanliness can present a significant revenue opportunity for businesses that have the flexibility to manufacture hand sanitizer. Conceptually, the Big Message from FDA is simple; assist in COVID-19 prevention by making hand sanitizer, and FDA will not pursue enforcement actions.

In the guidance document released by FDA on April 15, 2020, Temporary Policy for Preparation for Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry, FDA has officially announced relaxed enforcement (“enforcement discretion”) of the Adulterated Drugs and Devices (21 USC 351) chapter of the Federal Food, Drugs and Cosmetic Act.

The purpose of this article is to provide background information on the scope of federal emergency action, to identify relevant sections of public acts and laws which provide immunity from liability, and finally to discuss the requirements in the FDA’s guidance document on emergency manufacture of hand sanitizer.

Background on Scope of Federal Emergency Action

There are several bureaucratic layers to peel back in order to understand a company’s responsibilities and risks from taking part in the emergency manufacture of hand sanitizer. The following is relevant background information to clarify the authority of the FDA versus HHS in this health crisis.

There are states of emergency and there are public health emergencies (PHE). The two are not the same. While they can occur simultaneously, one does not necessitate the other and each opens its own set of bureaucratic doors. Different governmental bodies are responsible for activating these states.

A public health emergency is declared by Health and Human Services (HHS). It is a tool with statutory and regulatory weight and reference. It is also specifically identified in the Federal Food Drug and Cosmetic Act and recognized by the FDA. This statutory condition paves the way for emergency use of medical products, emergency development and review of medical products, and priority review to encourage treatments for agents that present national security threats. (These are all sections under 21 USC Chapter 9 Subchapter V, parts A and E.)

The guidance document states clearly the relaxed oversight will last for, “…the duration of the public health emergency as declared by the Secretary of Health and Human Services (HHS) on January 31, 2020,” (Food and Drug Administration, 2020). The PHE for the COVID-19 outbreak was declared January 31, 2020, and was retroactive to January 27, 2020. Per 42 USC 247d, the Secretary may extend the public health emergency for up to 90 days[1]. On April 26, 2020, Secretary Azar of HHS made the first extension of the public health emergency. It is likely the PHE will be extended again on or around July 26, 2020. A comparable example of the duration of a public health emergency is the H1N1 flu outbreak in 2009.

HHS declared a public health emergency related to H1N1 which lasted from March 22, 2009, through June 22, 2010. If this is the case with COVID-19, companies new to the world of FDA regulated manufacturing may have over a year to learn, implement and optimize this stream of revenue before becoming concerned about enforcement activities from FDA.

HHS Public Act and Declaration Providing Immunity from Liability

Another important detail of the PHE and the supporting bureaucracy is that the PREP Act (aka Public Law 109-148) has been declared applicable to this crisis. The PREP Act was written and signed into law in 2005. Division C of the Act provides immunity to manufacturers acting in good faith to address public health emergencies. The Secretary of HHS may (and has for the COVID-19 outbreak) issue a declaration to provide:

“…liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP[2] Act,” (Health and Human Services Department, 2020).

An advisory opinion issued by HHS on April 14, 2020[3] cites the PREP Act and specifies covered countermeasures include, “…any other drug…used to treat, diagnose, cure, prevent, or mitigate COVID-19….” (Department of Health & Human Services, 2020). As FDA classifies hand sanitizer as an Over-The-Counter (OTC) drug product, it falls within the definition of a covered countermeasure and as such immunity from liability is applicable. It is important to reiterate immunity does not apply in the face of willful misconduct which is clearly defined in the PREP Act (Public Law 109-148 section 319F-3(c), Definition of Willful Misconduct).

During the declared PHE, companies still have a responsibility to manufacture products ethically and honestly. Once this relaxed oversight ends, companies will be expected to strictly adhere to FDA regulations for manufacturing OTC drug products.

Emergency Provisions to Manufacture Hand Sanitizer in the FDA Guidance Document

As mentioned, hand sanitizer is classified as an Over-the-Counter (OTC) drug product. Production is normally regulated by 21 CFR 330. As a drug product, it is also normally subject to the regulations commonly referred to as current Good Manufacturing Practices (cGMP) captured within 21 CFR 210 and 211.

Even though a PHE has been declared, and FDA has specifically stated it does not intend to take action against firms for the duration of the emergency, 21 CFR 210, 211, and 330 still do apply. Companies should adhere as best as possible to these regulations when starting emergency manufacturing for hand sanitizer. As enforcement is presently relaxed, this is a prime opportunity to begin ethical manufacturing while simultaneously developing processes and procedures to ensure strict FDA compliance for when the PHE is lifted.

Nine circumstances are needed to be able to manufacture hand-sanitizer for public use:

• Permission/Firm registration

Firms need to register with FDA. An electronic registration system exists. Instructions to register can be found here: https://www.fda.gov/drugs/drug-registration-and-listing-system-drls-and-edrls/electronic-drug-registration-and-listing-instructions

This link will direct businesses wishing to register to a webinar created by FDA that guides a company through the registration process.

Bear in mind, hand sanitizer is considered a drug/drug product. It may be confusing to see this language in relation to hand sanitizer, however, it is industry ‘lingo.’

• Formulation

The recipe/formulation is limited to 4 ingredients in proportions following the World Health Organization (WHO) guidelines. The FDA guidance document linked at the beginning of this article provides the formulation details. This means scents/flavors must be excluded from the formulation.

The finished product concentration cannot be below 80% for ethanol-based and 75% for isopropyl alcohol (IPA) based sanitizers. Specific grades of ingredients required and identified in the guidance document.

Ethanol and IPA are the only two alcohols identified by WHO and acceptable per the guidance document. Be cautious to avoid using any ingredients listed under 21 CFR Sec. 310.545 as anything listed there requires approval for use via a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and are outside the scope of FDA’s enforcement discretion for emergency hand sanitizer production. The attachment at the end of this article identifies the section of 310.545 specific to hand washes and provides a link to yet another FDA guidance document on hand cleansing products.

• The alcohol used must be denatured. The guidance document identified several acceptable denaturants. Additionally, the CARES Act (H.R. 748 Section 2308) declared a temporary exemption from excise tax for alcohol used to produce hand sanitizer[4].
• Batches need to be tracked.

Even though FDA has indicated it does not intend to take enforcement action, batch records, and by inference, Good Documentation Practices (GDP) still apply. Simple forms are acceptable to track batches. Each batch should have a traceable lot number.

• The hand sanitizer should be manufactured under sanitary conditions using appropriate equipment. If manufacturing lines are being converted from another product, care should be taken to avoid cross-contamination with that other product. Per the guidance document, insanitary conditions must be prevented.
• Businesses must test and verify the final alcohol concentration. The guidance document identifies a few means considered acceptable to accomplish this.
• Relaxed guidance is limited to one formulation.

Foams, aerosols, etc., cannot be manufactured under this emergency guidance document. This is because other formulations may contain more than the 4 ingredients identified by WHO.

• Adverse event reporting mechanism

Firms must have an adverse event reporting mechanism in place. At this point it does not need to be complex. However, it is recommended to concurrently author/issue an SOP that will identify the business approach to address reporting adverse events. When the public health emergency ends, this requirement will need to be part of routine manufacturing.

Any adverse event reported to the business will also have to be submitted to the FDA per the MedWatch Adverse Event Reporting program.

• Labeling/Packing

Specific labels identified and templates are included in the temporary guidance document. Additionally, specific packaging requirements that prevent alcohol evaporation are called out. The guidance document defers to the Department of Transportation (DOT) guidelines for transportation, stating DOT hazmat transport includes separate requirements for, “…classification, packaging, marking, labeling and other requirements relevant to transportation,” (Food and Drug Administration, 2020).

As stated at the beginning of this article, the Big Message from FDA is make hand sanitizer ethically and in good faith, and enforcement actions will not be taken against a firm. It appears this public health emergency is changing and shaping mindsets for the future. Routine production of hand sanitizer is likely going to become a significant revenue stream for enterprising companies willing to learn to navigate FDA regulations. Once the public health emergency ends, strict FDA compliance will be required. Automated Systems, Inc. has the experience and resources available to assist with a seamless transition into OTC manufacturing.

References

Department of Health & Human Services. (2020, April 14). Advisory Opinion on the Public Readiness and Emergency Preparedness Act and the March 10, 2020 Declaration Under the Act. Washington, District of Columbia. Retrieved from https://www.hhs.gov/sites/default/files/prep-act-advisory-opinion-april-14-2020.pdf

Food and Drug Administration. (2020). Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19). Silver Spring, MD: FDA.

Health and Human Services Department. (2020, April 15). Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19. Public Readiness and Emergency Preparedness Act, Public Law 109-148. Washington, District of Columbia. Retrieved from https://www.federalregister.gov/documents/2020/04/15/2020-08040/amendment-to-declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical#pri

 ATTACHMENT

• FDA final rule on ingredients considered generally recognized as safe (GRAS):

Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use, A Rule by the Food and Drug Administration on 04/12/2019

https://www.federalregister.gov/documents/2019/04/12/2019-06791/safety-and-effectiveness-of-consumer-antiseptic-rubs-topical-antimicrobial-drug-products-for.

Some ineligible active ingredients (listed below) require approval under NDA or ANDA

(e.g.: In today’s final regulation we finalized the FDA’s previous determination that 28 active ingredients, including triclosan and benzethonium chloride, are not eligible for evaluation under the FDA’s OTC Drug Review for use in consumer antiseptic rubs*)

• From the regulations:

(27)Topical antimicrobial drug products –(iii) Consumer antiseptic hand wash drug products. Approved as of September 6, 2017.

Cloflucarban

Fluorosalan

Hexachlorophene

Hexylresorcinol

Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)

Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)

Methylbenzethonium chloride

Nonylphenoxypoly (ethyleneoxy) ethanoliodine

Phenol (greater than 1.5 percent)

Phenol (less than 1.5 percent)

Poloxamer iodine complex

Povidone-iodine (5 to 10 percent)

Secondary amyltricresols

Sodium oxychlorosene

Tribromsalan

Triclocarban

Triclosan

Triple Dye

Undecoylium chloride iodine complex

(b) Any OTC drug product that is labeled, represented, or promoted for the uses specified and containing any active ingredient(s) as specified in paragraph (a) of this section is regarded as a new drug within the meaning of section 210(p) of the Federal Food, Drug, and Cosmetic Act (the Act), for which an approved new drug application under section 505 of the Act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application, such product is also misbranded under section 502 of the Act.

(c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for the OTC uses and containing any active ingredient(s) as specified in paragraph (a) of this section is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter.

(d) Any OTC drug product that is not in FDA compliance with this section is subject to regulatory action if initially introduced or initially delivered for introduction into interstate commerce after the dates specified in paragraphs (d)(1) through (d)(42) of this section.

• FDA News Release (04/11/2019) FDA issues final rule on safety and effectiveness of consumer hand sanitizers:

“At this time, three active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are being deferred from further rulemaking to allow for the ongoing study and submission of additional safety and effectiveness data necessary to make a determination regarding whether these active ingredients are generally recognized as safe and effective for use in OTC consumer antiseptic rub products. Their status will be addressed either after completion and analysis of the studies or at another time, if these studies are not completed. At this time, the FDA does not intend to take action to remove hand sanitizers containing these three active ingredients from the market.”

*https://www.fda.gov/news-events/press-announcements/fda-issues-final-rule-safety-and-effectiveness-consumer-hand-sanitizers

[1] 42 USC 247d.(a) “…Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first.”

[2] PREP Act (aka Public Law 109-148) can be found in Division C of the full document at this link, https://uscode.house.gov/statutes/pl/109/148.pdf and defines the scope of claims for loss.

[3] It is strongly recommended to read this publication by HHS to further understand liability and immunity as outlined in the PREP Act: https://www.hhs.gov/sites/default/files/prep-act-advisory-opinion-april-14-2020.pdf

[4] Link to CARES Act: https://www.congress.gov/bill/116th-congress/house-bill/748/text#toc-HA6F4D541DFE148BC860C0C3130ADE5A4

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The first step is to work with a company like ours. Automated Systems (ASI) has been providing staffing solutions to our clients for over 30 years and have strong relationships that cut through the red tape of the hiring process. At ASI, we still do things the old fashioned way; we read each resume that comes to us. Unlike some of our competitors, there are no “robots” prescreening for keywords or previous job titles. However, resumes must still be easily readable and well-formatted. A resume is your first and sometimes only contact with a company, it must tell your story accurately, truthfully and concisely.

Although it varies by job and company, an average job opening attracts 250 applicants. Because of this, on average a recruiter spends a mere 6 seconds scanning a resume. They scan for things like your career highlights, qualifications, and specific skills. And unless they can see that you are relevant in a single glance, chances are you’re not getting a phone call, let alone an interview. This means that you must make those first 6 seconds count, but how?

A well-written summary at the top of your resume is the best personal advertisement that you can utilize in today’s job market. This is the first section a recruiter or hiring manager is going to check. Look at it as an introduction to your resume. Do this right and your resume summary will be a giant flashing sign that says “Call me!” and “Hire Me!”

In the past an objective statement was used at the top of your resume to tell the hiring manager what job you were applying for and why. This was useful when all applications were hand-delivered or mailed in, so it was important to label your resume to make it stand out. However, objective statements have gone the way of the mullet, and are no longer considered contemporary. Objective statements take up precious space on your resume, stating something that doesn’t need to be said. “I am seeking an opportunity to work at your company” – would you have applied otherwise? Most applications are done electronically now and are directly tied to the original job post, no longer requiring the labeling.

A good resume summary, in a sentence or short paragraph, highlights some of your biggest achievements to date, mentions your profession and includes 1-2 of your top skills. You are not trying to explain your whole career in this section, you are just trying to get the person scanning your resume to continue reading. If you think of your resume as a fishing line, this is the bait and you can hook them once they have nibbled on it.

Example of a summary that needs work:

1. Passionate and high-skilled project manager with over 5 years of work experience with a sound knowledge of the industry. Hoping to take on new challenges and learn more on the job.
2. Qualified engineer with many years of experience. Would love to join your company to keep developing professionally and seek new challenges. Commended on numerous occasions by superiors and peers for dealing with difficult problems and resolving complex issues.

An example of a great summary:

1. Project manager with a proven track record of working with agile and waterfall project management methodologies. Managed 7+ teams of software projects over the past 3 years. Basic understanding of several programming languages, including Java, C+, and Python.
2. Experienced mechanical engineer with almost ten years of med device development experience. Created cutting-edge designs that met deadlines, budget restrictions, and product specifications. Using CAD technology, modeling, and analysis of structural components. Successfully participated in a trial team to enhance existing products.

An effective resume summary typically follows the following structure:

Your experience summary (how many years, doing what, etc.)

Your general experience (more specific skills, what’s your focus)

Your top achievements (career highlights, include quantifiable data)

Personalize your summary as much as possible for each role that you apply for. If you have experience in the software or job task that they have listed in the job description, try to highlight it. Be specific and include numbers if you are able, such as a budget amount or percent improvement. This is your chance to tell the recruiter or hiring manager that you are the candidate they are looking for. Grab their attention.

Although times are challenging right now, job searching still has the same fundamentals. Have a personalized, well-written resume and let it advertise for you. The phone will ring, make sure you answer it and we will get through this together.

Tune in for our next blog post in this series on how to make small changes on your resume for a big impact.

The post Writing a resume to get hired during unprecedented times appeared first on ASI.