Pelatihan
Internal
CPAKB
( Cara Pembuatan Alat Kesehatan yang Baik )
PT YUTAKA ASIA INDONESIA
FEBRUARI 2023
Materi Pelatihan
1 2 3 4
Regulasi
Manajemen Mutu Realisasi produk Pengawasan
&
Peran PJT
Regulasi
Peran PJT
Manajemen
Alkes
Aspek Manfaat
Persyaratan Umun
Sistem Manajemen Mutu
• Menetapkan proses u/ CPAKB • Mengimplementasikan tindakan
• Menentukan urutan dan interaksi proses yang dibutuhkan untuk mmencapai
• Menentukan kriteria dan metode untuk hasil yang direncanakan dan
menjamin efektifitas implementasi dan mempertahankan keefektifan proses
kendali dari proses ini
• Menjamin ketersediaan sumber daya dan • Menentukan bagian dan fungdi pada
informasi untuk mendukung pelaksanaan perusahaan yang memiliki tugas dan
dan pemantauan proses tanggung jawab yang ditetapkan
• Memantau, mengukur, dan menganalisi secara jelas dan tegas.
proses ini.
Rekaman
Penyimpanan Rekaman
Min 2 tahun
Max Expired produk
Rekaman Harus :
Disimpan Dipelihara Mudah diperoleh kembali
Pelaporan
E-Report per 6 bulan
Audit Internal
Kegiatan yang dilakukan untuk
memastikan efektifitas sistem manajemen mutu
dengan menganalisis problem mutu dan melakukan perbaikan secara terus menerus
Pelaksanaan
Minimal 1 tahun sekali
Dokumentasi
Tim Auditor • SOP AUDIT INTERNAL
Ditetapkan melalui surat penujukan • AUDIT PLAN
• JADWAL AUDIT
Auditor telah mengikuti pelatihan CPAKB • DAFTAR PERIKSA
• DAFTAR HADIR NOTULEN
Hasil
Bahan Kajian Manajemen (Evalusi)
Kajian Manajemen
INPUT OUTPUT
1. Hasil audit (Internal & Eksternal) 1. Perbaikan yang dibutuhkan untuk
2. Umpan balik Pelanggan mempertahankan kefektifan SMM
3. Kinerja proses dan kesesuaian produk 2. Perbaikan produk yang terkait
4. Status tindakan perbaikan dan korektif
5. Tindakan dari kajian manajemen
persyaratan pelanggan
sebelumnya 3. Sumber daya yang dibutuhkan
6. Perubahan yang dapet mempengaruhi
smm
7. Rekomendasi untuk pengembangan
8. Persyaratan regulasi baru
MANAJEMEN RISIKO
Proses sistematis untuk
menilai, mengontrol, dan mengkaji
risiko terhadap mutu alkes yang dapat ditimbulkan
Akibat adanya penyimpangan sehingga dibutuhkan pencegahan dan koreksi
PENGAWASA
N ALKES
sesuai
CPAKB
Penanganan
keluhan
Palsu Ilegal Tidak
memenuhi
syarat
Penanganan Produk
Tidak Sesuai
Recall
Jangka Waktu
Penarikan
Pemusnahan
Kewaspadaan Kegiatan post market yang
dilakukan oleh pelaku usaha
untuk melindungi kesehatan
Prosedur : dan keselamatan pengguna di
-Proses pengumpulan dan penerimaan masyarakat yang berhunbungan
-Evaluasi dan pelaporan aspek kemanan dengan KTD, RCA, FSCA dan FSNI
-Tindak lanjut yang diperlukan
Whoa!
Terimakasih
Pelatihan Internal
CPAKB
PT YUTAKA ASIA INDONESIA
FEBRUARI 2023
How our system works
Pluto Ceres
Pluto is now seen as a Ceres is in the main
dwarf planet asteroid belt
The Moon
The Moon is Earth’s only
natural satellite
Materi Pelatihan
1 Day 6 Day 7 Day 8
Regulasi dan Jupiter is a big Mars is a cold Venus is very
peran PJT planet place hot
Icon pack
“This is a quote, words full of
wisdom that someone
important said and can make
the reader get inspired.”
—Someone Famous
“This is a quote, words full of wisdom
that someone important said and can
make the reader get inspired.”
—Someone Famous
“This is a quote, words full of
wisdom that someone
important said and can make
the reader get inspired.”
—Someone Famous
The slide title goes here!
Do you know what helps you make your point clear? Lists like
this one:
● They’re simple
● You can organize your ideas clearly
● You’ll never forget to buy milk!
And the most important thing: the audience won’t miss the point
of your presentation
General characteristics
Do you know what helps you make your point clear? Lists like
this one:
● They’re simple
● You can organize your ideas clearly
● You’ll never forget to buy milk!
And the most important thing: the audience won’t miss the point
of your presentation
01
Company
You can enter a subtitle here
01
Company
You can enter a subtitle here
A picture is worth a
thousand words
A picture is worth a thousand words
Maybe you need to divide the content
Mercury Venus
Mercury is the closest planet to the Venus has a beautiful name and is the
Sun and the smallest one in the Solar second planet from the Sun. It’s hot
System—it’s only a bit larger than the and its atmosphere is poisonous
Moon
You can use three columns, why not?
Mars Jupiter Saturn
Despite being red, it’s a cold It’s a gas giant and the Saturn is the ringed planet.
place. It’s full of iron oxide biggest planet in the Solar The planet is a huge gas
dust, which gives the planet System. Jupiter is the fourth- giant, composed mostly of
its reddish cast brightest object in the sky hydrogen and helium
About us
Neptune is the farthest planet
#1 Our mission from the Sun
Mercury is the smallest
#2 Our vision planet of them all
Pluto is now seen as a dwarf
#3 Our values planet
You can use two columns
Mercury Venus
Mercury is the closest planet to the Venus has a beautiful name and is the
Sun and the smallest one in the Solar second planet from the Sun. It’s
System. It’s only a bit larger than the terribly hot and its atmosphere is
Moon poisonous
02
Our offices
You can enter a subtitle here
02 Our offices
You can enter a subtitle here
A picture always
reinforces
the concept
Images reveal large amounts of data,
so remember: use an image instead
of long texts
A picture always
reinforces the concept
Images reveal large amounts of data, so
remember: use an image instead of a long text.
Your audience will appreciate it
Awesome
words
Awesome
words
Awesome
words
Percentages
21% 95%
Oxygen on Earth Carbon in Mars
Areas of expertise
Enterprises E-commerce
35% 65%
Mercury is the smallest Venus is the second planet
planet of them all from the Sun
Use a graph to show your data
32% Venus
78% Mars
45% Jupiter
To modify this graph, click on it, follow the link, change the data and replace it
Our competitors
Competitor A Competitor B
Mercury is the smallest planet in the Venus is the second planet from the
Solar System Sun
Competitor C Competitor D
Earth is the only planet that harbors Despite being red, Mars is actually a
life cold place
Our services
Service #1 Service #2 Service #3
Jupiter is the biggest planet Saturn is a gas giant and has Neptune is the farthest planet
of them all several rings from the Sun
Service #4 Service #5
Mercury is the smallest Ceres is located in the main
planet of them all asteroid belt
Reviewing concepts is a good idea
Mercury Venus Mars
Mercury is the closest planet to Venus has a beautiful name, but Despite being red, Mars is a
the Sun it’s terribly hot cold place
Jupiter Saturn Neptune
It’s the biggest planet in the Saturn is the ringed planet and Neptune is the farthest planet
Solar System a gas giant from the Sun
Our specialties
Specialty A Mercury is the closest planet
to the Sun
Venus is the second planet Specialty B
from the Sun
Specialty C Earth is the third planet from
the Sun
Despite being red, Mars is Specialty D
actually a cold place
Specialty E Jupiter is the biggest planet of
them all
Saturn is a gas giant and has Specialty F
several rings
Use a graph to show your data
45.7% Venus
50% Mars
4.3% Jupiter
To modify this graph, click on it, follow
the link, change the data and paste the new
graph here
Our clients
Mercury 100
Mercury is a close
75
planet to the Sun
50
Venus
25
Venus has really high
temperatures
0
Mars Mars Mars
Earth
Earth is the only planet Follow the link in the graph to modify its data and then paste the new
one here. For more info, click here
that has life
Infographics make your idea understandable...
Despite being red, Mars is a cold place
Mercury is the closest planet to the Sun
Jupiter is the biggest planet
Venus is terribly hot
Business chart
A successful business
Mercury is the smallest planet in the entire
Solar System
Idea A Idea B Idea C Idea D
Venus has a Mars is actually a Saturn has several Ceres is in an
beautiful name cold place rings asteroid belt
Earth Jupiter Neptune The Moon
Earth is where we Jupiter is the Neptune is far away The Moon is Earth’s
all live on biggest planet from us satellite
This is a table
Mass Diameter Gravity
(earths) (earths) (earths)
Mercury 0.06 0.38 0.38
Mars 0.11 0.53 0.38
Saturn 95.2 9.4 1.16
Business meeting
Mon Tue Wed Thu Fri
Introduction Speech 2 Activity 3 Tech 3 Speech 5
Speech 1 Activity 2 Speech 3 Activity 4 Tech 4
Activity 1 Tech 1 Tech 2 Speech 4 Activity 5
Conclusions
Conclusion 1:
Write a conclusion here
Conclusion 2:
Write a conclusion here
Conclusion 3:
Write a conclusion here
386,000 km
Distance between Earth and the Moon
This is a map
Jupiter is the
biggest planet
Venus has a
beautiful name
Mars is a cold place
to live on
Our locations
Headquarters
The Sun is the star at the center
of the Solar System
Admin office
Ceres is located in the main
asteroid belt
Design office
The Moon is Earth’s only
natural satellite
Another slide with three columns
Mercury Venus Mars
Mercury is the closest planet Venus has a beautiful name Despite being red, Mars is
to the Sun and the smallest and is the second planet from actually a very cold place.
one in the Solar System the Sun. It’s terribly hot It’s full of iron oxide dust
1961 Mercury is the smallest planet of
them all
1969 Jupiter is the biggest planet of
them all
1981 Saturn is a gas giant and has
several rings
4,498,300,000
Big numbers catch your audience’s attention
<200%
Big numbers catch your audience’s
attention
360,000 km
Distance between Earth and the Moon
333,000
The Sun’s mass compared to Earth’s
9h 55m 23 s
Jupiter’s rotation period
Important
words
Because key words are great for
catching your audience’s attention
Our team
Maria Luis Ana
You can speak a bit about You can speak a bit about You can speak a bit about
this person here this person here this person here
Our team
Ana Alvarado Adam Williamson
You can speak a bit about You can speak a bit about
this person here this person here
Desktop mockup
You can replace the image on the
screen with your own work. Just delete
this one, add yours and center it
properly
Tablet mockup
You can replace the image on the
screen with your own work. Just delete
this one, add yours and center it
properly
Phone mockup
You can replace the image on the
screen with your own work. Just delete
this one, add yours and center it
properly
Mockup devices
You can replace the images on the screen with your own work. Just right-click
on them and select “Replace image”
Thanks!
Do you have any questions?
addyouremail@[Link]
+91 620 421 838
[Link]
CREDITS: This presentation template was created by
Slidesgo, including icons by Flaticon, and infographics &
images by Freepik
Alternative resources
PHOTOS
● Smart phone with white display screen on white table
● Business executives discussing with their colleagues
● Business people at the office
● Group of young professionals working together
● Portrait of young male enjoying work
● Woman working with laptop
Alternative premium resources
Here’s an assortment of alternative resources whose style fits the one of this template:
PHOTOS
● Full shot colleagues working together
● Full shot smiley colleagues posing together
● High angle people working together
● High angle smiley colleagues working
● Business man banner concept with copy space
● Business woman banner concept with copy space I
● Business woman banner concept with copy space II
● Business colleagues banner concept with copy space I
● Business colleagues banner concept with copy space II
● Empowered business woman working in the city I
● Empowered business woman working in the city II
● Empowered business woman working in the city III
● Financial independent woman buying new house
● Three businesspeople looking at business report in the office
● Medium shot man working on laptop
Resources
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PHOTOS
● Man and woman coworking with papers
● Thoughtful man at laptop in office
● Cheerful coworkers with papers
● Cheerful people in office
● Thoughtful people doing paperwork
● Collaborating man and woman with papers
● Lovely woman working in office
● Happy successful female student posing with arms crossed
● Portrait of a smiling young man in eyewear
● Portrait of a smiling casual woman
● Minimalistic working desk with blank monitor screen
● White stationery and tablet on desk
● Top view smartphone template over workspace
Premium resources
Did you like the resources on this template? Get them for ● Group of businesspeople looking at business plan
free at our other websites. in the office
PHOTOS ● Close-up of a woman examining document
● Smiling young woman working at laptop in office
● Smiley woman at work medium shot ● Ethnic young employee working at laptop
● Businessman and a businesswoman
● Front view women working together
● Young man using laptop with coffee cup and digit
al tablet on kitchen counter
ICONS
● Industrial designers working on 3d model
● Empowered business women working ● Mentoring and Training | Lineal
● Medium shot empowered business woman
● Teamwork concept with business people
● Low angle womens team meeting
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JANUARY FEBRUARY MARCH APRIL MAY JUNE
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Text 1 Text 2 Text 3
“Mercury is the “Despite being red,
smallest planet in Mars is actually a
the Solar System” very cold place”
Add the title here 2016 2017 2018 2019 2020
“Venus is the
“Neptune is the “Saturn is a gas
second planet from
farthest planet from giant and has
the Sun and is
the Sun” several rings”
terribly hot”
Text 4 Text 5 Text 6
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75% “Despite being red,
Mars is actually a
very cold place”
75%
“Jupiter is the
TITLE 1 biggest planet in the
entire Solar System”
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Solar System”
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several rings”
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