Webinar: Best practices for validating literature monitoring searches

Webinar registrationIn the context of literature monitoring for adverse reactions to medicinal products (EMA GVP Module VI), a reasonable number of Market Authorization Holders have no ready answer to justify why they use each search formula for each specific product when Audit or Inspection time comes: in fact the search formula, responsible for all the inbound traffic in the Literature Monitoring process is, many times, not validated, or regularly reviewed. How does one create a “good” PV search formula for Literature Monitoring and validate it? By “good” we understand: a formula where you can justify, to an auditor or inspector, why do you use it instead of any other -one-.

In this webinar, I will discuss the process of (re-)validation of the search formulas used for literature monitoring in the context of EMA’s GVP Module VI. This will enable you to create and fine tune the search formula and, when needed, present evidence, to an auditor or inspector, on each search formula fitness for purpose.

Please register at https://attendee.gotowebinar.com/register/7681457997368414209

If we think of Documentation as a SPRINT deliverable, can we indeed have Agile and CSV?

Question on a LinkedIn group:

V model for Agile?

Life Science industry is using traditional V model for CSV. Should this model be changed for Agile based development, testing and validation.
I believe we should be able to use the user stories instead URS as the basis of V model. Please share your thought. Thanks

PJ Singh, PMP
Co-Founder & Director – Quality, Compliance, Validation, and Technology Integration

I’ve found out, during my tenure as Scrum PO for a GxP regulated product, that if you have a documentation resource, usually a Business Analyst, embedded in the SCRUM team, constantly making sure that there is documentation alignment between URS and User Stories, and make the documentation part of the Definition of Done, you can have a very strong alignment between V model and Agile practices.

I’m willing to propose and defend that, for implementing CSV while practicing Agile, one needs to have Documentation as a SPRINT deliverable.

Stupid questions in job interviews (1 of many)

The question: “Where do you see yourself in 5 years? ” does not make any sense.

I hope your offer is interesting enough so that my job description, 5 years from now,  will include several tasks and competencies that do not even exist today.

And that is where I see myself in 5 years, in your company: Doing something that CAN’T BE DESCRIBED TODAY!

I am pretty sure, it will take less than two years anyway for the “never saw that coming” to emerge in the performance indicators.

 

 

 

 

21 CFR 11 Reflections: 10(a,c,d)

When I read regulatory documents I always try to imagine what possible reason can there be for someone to write a regulation and what may have been the real world case(s) that will be prevented by that text.

Sometimes it is clear that a text not only is intended to have specific consequences, but also is based on real historic situations that went bad for the community… because the regulation was not in place. Anybody with more than 5 years in programming and system management can clearly see the root cause for almost each and every item in 21 CFR 11 .

For Example:

21 CFR 11.10(a): Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

This imposition must derive from situations where the regulated company said that the “software” was bought as it was, in full confidence that the sellers promises of quality and fulfillment of the regulatory requirements, were true.

Many times the promises may even have been made in good faith but if an audit shows that the software product does not fill the requirements, does not impede irregular situations, etc… then the regulated company is at fault of not doing due diligence during the procurement process.

21 CFR 11.10(A) requires that regulated companies perform due diligence when contracting a piece of software for purposes that are regulated. And the due diligence, albeit Validation can mean many different things, simply means that the regulated company should draw a set of requirements and that it should verify and document that the contracted software fulfills the requirements.

Most of the FDA documents regarding Electronic records are just codified common sense, like: “[…] we believe it would not be prudent to store both primary and backup electronic records
on the same computer hard drive because both could be lost if the hard drive fails.” Draft of  “Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures; Maintenance of Electronic Records”

Does this mean that “Backups must not reside on the same Infrastructure as the original backed up data” should go into the Requirement Specification? Yes. As a requirement of 21 CFR 11?  If that is the way to get the requirement in there. But it should be in the specification because it is common sense.

 

SCRUM MASTER Certification @ RUMOS w/ Peter Stevens

I did the Scrum Master certification course with Peter Stevens, facilitated by the Portuguese training company RUMOS.

Having recently being appointed Senior Product Development Manager at Elsevier R&D, with a strong requirement in acting as Product Owner for the relevant agile Teams, this was a must have.

The course was delivered  following a SCRUM approach, ie: each module was a separate ticket with specific acceptance criteria. A Kanban board was always visible indicating the status of the whole course, making many of the learning objectives self evident. Many artifacts were used routinely throughout the course, much earlier than their formal introduction to the audience.

The training team (pedagogical dyad ? ) also counted with Hugo Lourenço, a collaborator of Peter Stevens, for quite some time.

The hands-on exercise was very interesting and a clear introduction to the pressures of a real SCRUM cycle, in real time, from Vision to Delivery, in  60 Mins. I leave the readers to find what the exercise is by attending the course.

There were some novel (at least for me) pedagogical devices, like calling for us to look for aha moments (I collected several) and conversations to start Monday morning at the office, preferably around the coffee machine.

Next week I’ll be attending the Product Owner specific course in Oporto. Looking forward to it.

 

A Portuguese abroad

Let it be known that the Minister who told the Portuguese people to seek a job abroad … was perfectly right! We are as good as anyone else in Europe, and probably in the world. Our great professionals are as good as the great professional of any other country.

Those who stay in Portugal deserve each other company… politicians more that the citizens.

After all, Portugal is today, what was made by those who did not participate in multiple Diasporas of the Portuguese peoples… Portugal is what the “Old Men from Restelo” built! We usually pride ourselves on the Discoveries… but we are descendants of those who stayed, who did not participate in the adventure.

On the other hand I miss Portugal dearly… and that is Saudade.

Travel

Traveling all the time… both for work and for family… 5 in the morning is now usual for me. Almost achieved Platinum level on KLM

 

Saudades

O melhor remédio é o Skype.

A seguir é a APP Sapo Jornais… Capas de jornais e notícias fresquinhas todas as manhãs.

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Que tal viver na Holanda? Clima

Quando faz frio, faz a sério. Quando faz vento… idem idem aspas aspas, que para as massas de ar que vêm do Árctico ou da Sibéria, a diferença entre a Holanda e o Mar do Norte é nenhuma.

O primeiro inverno foi um suplicio.

O de 2014 foi mais fácil, principalmente pela ausência de neve… mas chuva não faltou. O de 2015 ainda não teve neve a sério…

Calor… nunca tive. Seria mesmo capaz de jurar que nunca vi mais de 28 graus… e mesmo isso é mau: as casas estão feitas para manter o calor dentro… não sabem refrescar.

Outra coisa interessante: é possível saber, quase ao minuto, quando vai chover: O site Buienradar.nl mantém uma imagem completa e actualizada em tempo real de onde está a cair água em todo o Benelux. As previsões horárias (com 5 dias de antecedência) dão para programar uma ida ao supermercado ou uma volta ao lago!

New year, new life…

After a very hard year came evaluation season, and it was positive … in fact very positive …

The bosses clearly thought I was ready for new challenges. They have changed my job and I am now what I never thought I would become: a consultant. And a consultant who instead of having only customers in EMEA, is now responding to customers worldwide.

Interesting, too, that in the new roles I have, once again, to learn a lot of new things. This time around its the Code of Federal Regulations Ttitle 21, Chapter 11, EUudraLex Volume 4 Annex 11 and also PIC/S GMP GUIDE Annex 11. This more or less shows what I am doing, although it make no sense (at first glance) for a publisher editor of scientific journals and books.

Plus, all I learned last year about GAMP, is to be certified this year.

Regardless of the work ahead it is good to see that if it is recognized.