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Compliance

The 12 Days of Quality

The 12 Days of Quality

Deck the halls with boughs of…quality? That’s right! The holiday season is upon us, and while we’re busy spreading cheer and joy, let’s not forget to celebrate the unsung heroes of our industry – Quality Assurance (QA) professionals. In the spirit of the season, we present to you “The 12 Days of Quality” which highlights the importance of QA in a lighthearted way. So grab your cocoa, put on your favorite holiday sweater, and embark on this merry journey!

Verse 1: On the First Day of Compliance, QA Gave to Me…

‘Twas the start of the holiday season, and in the Biotech and MedTech wonderland, Quality Assurance (QA) came bearing gifts. On the first day of compliance, QA sent to me a thorough SOP review, setting the tone for a festive season of quality control and joyous documentation.

Verse 2: On the Second Day of Compliance, QA Gave to Me…

The second day unfolded with excitement as QA bestowed upon us two validation protocols, adding a dash of validation cheer to our holiday preparations. Deck the halls with data integrity and precision!

Verse 3: On the Third Day of Compliance, QA Gave to Me…

As the third day dawned, QA rocked our world by delivering three CAPAs closing—because nothing says “Happy Holidays” like closing those corrective and preventive actions with finesse. Sing it loud, sing it proud, it’s a CAPA-cappella!

Verse 4: On the Fourth Day of Compliance, QA Gave to Me…

The fourth day came bearing gifts of four risk assessments, reminding us to check our lists twice and mitigate risks for a worry-free celebration. Safety first because no one wants a compliance Grinch stealing the holiday spirit.

Chorus: FIVE GMP UPDATES!

On the fifth day, QA surprised us with a festive chorus, singing loud and clear, “FIVE GMP UPDATES!”—a melody to resonate through the cleanrooms and laboratories, ensuring Good Manufacturing Practices are in tune with the holiday harmony.

Verse 6-12: The Cheeky Compliance Cascade

In the following days, QA continued their cheeky compliance cascade:

On the sixth day, six audits-a-waiting, because what’s a holiday without a bit of suspense and surprise inspections?

Day seven brought seven deviations detailing, turning deviations into holiday decorations, because why not make non-conformances festive?

On the eighth day, eight inspections were prepping, as QA danced through the halls, prepping for the grandest performance of the year—the regulatory inspection!

Nine change controls arrived on the ninth day, a symphony of adjustments ensuring our holiday processes stayed in harmony.

Tenth-day festivities featured ten training sessions, keeping the team in tiptop shape to tackle any compliance challenge that came our way.

SOP revisions took center stage on the eleventh day, with eleven revisions making sure our standard operating procedures sparkled like tinsel on a Christmas tree.

Finally, on the twelfth day, QA delivered twelve validations passing, a grand finale to cap off the celebration—a testament to the hard work and dedication that ensures our products meet the highest standards.

As the festive jingle of compliance echoed through the manufacturing floors, laboratories and boardrooms, we embraced the holiday season with open arms, knowing that the 12 days of quality compliance had paved the way for a year of success, innovation, and, of course, a bit of cheeky compliance cheer! Wishing you a compliant and joyous holiday season! 🎄🎁✨

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Jackie Torfin - CEO and Principal Advisor for QLeaR Advisors

About Jackie Torfin

Jackie has over 30 years experience and deep expertise in quality, regulatory, pre-clinical and clinical compliance. She has served in Senior Global roles for companies including Beckman Coulter, NAMSA, CIMA Labs, PDL BioPharma, Arizant/3M, and Heraeus.

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