EU MDR’s Implementation Postponed for One Year

On Friday 17 April 2020, the European Parliament adopted the European Commission’s proposal to postpone implementation of tThe EU’s Medical Devices Regulation (MDR) 2017/745 for 12 months due to the COVID-19 pandemic and the potential impact it will have on EU MDR implementation. 

The proposal also has to be approved by the member states and published in the Official Journal of the European Union (OJEU) before it enters into force. This is to be by 26 May 2020 at the latest. Once in force, the new Date of Application for the MDR will be 26 May 2021.

jel@jelincoln.com

Note:  Complete transition has been further delayed.  JEL 09/20/2023 

Job Hunting

My response (slightly expanded) to a discouraged new job seeker on a forum.  Appropriate in view of the current job market.

The first job is the hardest. Get any experience you can including internships, temp and/or part time. Include responsible volunteer positions you may have filled. 

Try to get in front of the actual hiring person, rather than HR. Approach the hiring person with what you can do for them / their company, based on your research about their company on the Internet, friends who've worked there, etc. Do not focus on or imply you want the job to get a car and a place to live (your personal reasons). Focus on their needs and your proven qualities that would help them to meet those needs. 

For starters, I find it helps to compile a personal list of abilities, accomplishments, by going over my past life (several times), and writing down / listing those actions, projects, events, that I felt proud of, that were noteworthy accomplishments, that moved something forward, maybe in spite of problems / obstacles / challenges (not necessarily job related, but school, personal, sports, volunteer, community ...), and then rewriting them into business advantages / tools /qualities, using business terminology. E.g., were you successful in assisting in getting some activity started, running, and finished - see how that could be adapted to successfully leading / managing a business project (project management; self-starter, self-managed).  Change your personal terminology into business terminology -- learn some of the related tools, e.g., project management tools: flow charts, the Gantt Chart (easy to learn and implement on a word processing app or spreadsheet app. -- Google helps here for examples / explanations; and you don't need a certificate, just enough familiarity to adapt, define,  run, explain, and complete a small project).    . 

Have a "story", real examples, of how you would meet their business needs, by how you actually met similar needs / challenges in the past, the steps you took, your thinking / actions / approaches ... Role-play with a mature friend so your responses become 2nd nature. Expect and welcome open-ended questions, like "tell me a little about yourself'", by not giving your life story, hobbies, personal interests, but target your response - maybe even rephrase their question and then reiterate your qualities that fit their needs. 

And don't talk yourself out of a potential job interview because you think it doesn't seem to fit. If it appears close: Apply. Go. Do the above, and if the job offer doesn't come, at least it was their decision, not yours. You'll get more experience at job interviews, and, more importantly, I personally have seen other opportunities open from the same company when the initial job wasn't a fit, but they liked what I brought to the table, and knew of a future opening that would be a great fit. Look for openings before they're advertised by talking about what you're doing (and listening) with all your contacts, since there will then be less competition = networking. Be professional / modest in appearance (dress one step up from what would be called for in the actual position), conduct, language, conversation, word choice, etc. Minimize anything off-putting, e.g., piercings, tattoos, wild hair styles / colors, etc., unless those are typical of that workplace. 

And recognize that there will be many "nos" until the "yes", so don't let the experience affect your self-worth (easier said than done). Be positive and smile, even if you don't feel that way inside.

John E. Lincoln   jel@jelincoln.com

AI -  with AI increasingly taking the typical entry jobs or internships, look to develop skills needed that AI can't easily address, e.g., verbal and written communication skills, interpersonal / project management (especially work breakdown structure / reverse engineering...) skills, presentation / story-telling skills, specific beyond-entry level job related skills (including those adaptable from "unrelated" jobs / training / certifications, etc.)   The more specialized the skill / knowledge, the less challenge from accurate AI (currently).

-  JEL, 08/15/2025

Don't let the current COVID-19 cautions stop your company's internal and vendor inspections / audits.  Learn remote approaches and tools to conduct successful cGMP compliance inspections / audits 100% remotely.  Check out my latest new webinar on:

CONDUCTING  REMOTE / VIRTUAL  CGMP INSPECTIONS  DURING  COVID-19 -

PER US FDA CGMPs and EU ISO  

at

https://jelincoln.com/GMPCourses.html

jel@jelincoln.com

Some of my upcoming webinars:


FDA CDS Software Regulation: The Latest Guidance on Clinical Decision Support Software 19-May, 2020 at 01:00 PM ET.
https://www.eventbrite.com/e/fda-cds-software-regulation-the-latest-guidance-on-clinical-decision-support-software-tickets-85457099485


Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements 10-June, 2020 at 01:00 PM EST 
https://worldcomplianceseminars.com/webinardetails/799

How to Deploy Root Cause & CAPA to Minimize Human Error 24-June, 2020 at 01:00 PM ET

https://worldcomplianceseminars.com/webinardetails/848 Medical Device Change Management 08-July, 2020 at 01:00 PM ET  https://worldcomplianceseminars.com/webinardetails/849 jel@jelincoln.com

Questions / Answers from my recent IQ, OQ, PQ Webinar

1. Ques: when leveraging vendors' documentation, for example SAT testing leveraging into qualification, what are the main principles to be in place.

Ans:  Take your VMP requirements for the validation of that piece of equipment, subtract those SAT-satisfied tests, and develop test cases for the remainder, including any SAT tests that may be negatively impacted by actions upon the equipment since the SAT was performed, e.g., movement / transport, installation ... I've done this many times and had no push-back from regulatory agencies.  In fact it's specifically mentioned in ASTM E 2500 as an acceptable / preferred method.  

2.  Ques: what are the main principles with bracketing/family approach testing? 

Ans:  It would depend on the equipment family we're talking about (its complexity, inherent variability and end user risk).  As I mentioned in the webinar, I'm not much of a believer in Like-for-like, due to inherent variability in any equipment's manufacturing process.  But anything that is not (or minimally) subject to such variability, such as the equipment's software / firmware, in differing serial numbers of the same model of equipment, having the same software rev. no. / release no., could be considered, and those remaining / hardware elements, of minimal variability (based on data, or to a lesser degree, a priori considerations), if also low risk to the end user / patient, could be considered. 

Usually this "consideration" would mean that the validation of the 2nd , 3rd ... iteration of the "same" type of equipment, would be much reduced in possible number of test cases, number of elements in each test case,  reduced test case sample sizes (PQs), the numbers of PQs run, degree of repetitive descriptive documentation, etc., ... in subsequent validations compared to the first (of course, with cross-references in subsequent related validations to the initial validation).

In some / many cases the issue falls into a grey area, and it might be wise to validate, rather than try to develop a rationale and defend that rationale repeatedly with all stakeholders / inspectors, with the strong possibility after all that you could still lose the argument with a regulatory agency and have to validate anyway (been there, done that). 

jel@jelincoln.com  

A Question on My Recent Webinar on Project Management for FDA Regulated Companies

Query : I'm an informally trained Project Management ... Now I am working on launching product and don't have FDA/EPA experience and we are launching product that falls under either regulation. Would this course (Project Management for FDA regulated companies) be of help?

Ans:  Definitely.  This course focuses on use of simple PM tools to drive FDA projects  (basically PM for the non-PM certified manager).  We cover 3 key tools:  the Gantt Chart (emphasized), the  CPM, and the PERT (with the last two considered for their network, and parallel path illustrative value); also discussing additional tools such as flow charts and cause and effect diagrams to assist in developing Milestones and Tasks.

The projects discussed with sample milestones / templates are:  

• Design Control (21 CFR 820.30) / Design and Development Planning (ISO 13485:2016 7.3) for new device development; 
• Product / Process / Equipment / Software Validation; 
• Product Risk Management (ISO 14971); 
• Use Engineering / Human Factors Engineering (IEC 62366-1:2015); 
• Regulatory compliance inspection (Form 483) remediation.  

Due to the short length of the presentations, only the key milestones of each are listed / discussed, but that should be enough to start on the right path to use PM tools in those areas, fleshing out the tasks under the milestones by "reverse engineering", discussed in the webinar.  

Design Control does have an extensive Milestones / tasks listing, but most of the others only focus on Milestones.  

Though not discussed in the webinar, one could take the 21 "tabs" of the FDA's required 510(k) submission to develop the key Milestones for a 510(k) submission as well. 

jel@jelincoln.com

The 21 510(k) "tabs" have been added as project milestones discussed in subsequent versions of my Project Management webinars. - - JEL 09/20/2023

Key steps in the validation of the pharmaceutical manufacturing process per US FDA Guidance Document:

Process Validation Guidance Document (Pharma), US FDA,  Jan 2011

• Stage 1 – Process Design
• Stage 2 – Qualification
  • Part 1 – Facility Design
  • Part 2 – Qualification of Utilities & Equipment
    • Subsection 1 – Installation Qualification
    • Subsection 2 – Operational Qualification
    • Subsection 3 – Performance Qualification
  • Part 3 – Process Performance Qualification (PPQ)  
• Stage 3 – Continued Process Verification (ongoing)

John E. Lincoln, jel@jelincoln.com