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National and International Business System Standards
Food and Drug (Pharmaceuticals) related Regulations
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Qualification and Validation (including 21 CFR Part 11)
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ISO 13485 and ISO 14971 - Medical Devices and Related Forums
Marc
Oct 18, 2009
Replies
0
Views
10,628
Oct 18, 2009
Marc
Discussions
Z
Class 2 medical device - Process Validation - Test sterile or non-sterile units?
zenbot01
Mar 4, 2019
Replies
9
Views
1,801
Thursday at 6:19 AM
Muhammad Farooq
L
ASTM F88 Seal Strength of pouches - amount samples per pouch (discussion)
LarsZ
May 18, 2022
Replies
7
Views
374
Thursday at 3:14 AM
Disadolly
Q
Locked
Validation Guidance - Plastic Injection Molding Process
QE
Aug 19, 2009
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5
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46
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54,941
Aug 2, 2022
Xiomara
B
SPECIAL PROCESS VALIDATION & REVALIDATION
Borney
Dec 30, 2021
Replies
5
Views
828
Jul 20, 2022
weldingtorch
A
OpenText Documentum
attrayee
Jul 14, 2022
Replies
2
Views
127
Jul 16, 2022
attrayee
Q
IQ, OQ, PQ and Process Validation Sequence
qamama
Oct 25, 2010
Replies
8
Views
9,644
Jul 11, 2022
Vittoria
V
Retrospective validation medical devices
Vittoria
Jul 4, 2022
Replies
7
Views
308
Jul 8, 2022
Vittoria
I
Mixing tank sample points
ifserav
Apr 19, 2022
Replies
4
Views
387
Jun 3, 2022
Swimming In The Soup
S
Combo Product Assembly Process OQ
sunbike
May 27, 2022
Replies
0
Views
186
May 27, 2022
sunbike
S
Mixing criteria and sampling
Seasides
Apr 22, 2022
Replies
1
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305
May 21, 2022
v9991
A
FDA Audit Documentation - Recently released FDA Warning Letter
alex.Kennedy
Dec 14, 2011
2
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12
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5,124
May 19, 2022
Wes Bucey
J
Duplicate Band Sealers
jess1111
May 3, 2022
Replies
0
Views
166
May 3, 2022
jess1111
M
Do i need to have equipment validation if 100% testing is completed?
Manto
Jan 4, 2022
Replies
6
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667
Apr 13, 2022
chris1price
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Cloud Based System
Jeff007
Mar 31, 2022
Replies
7
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491
Apr 5, 2022
Jeff007
P
IQ, OQ, PQ protocol, and report templates for Distributed Control Systems in Pharmaceutical Manufacturing Systems.
Pranesh
Dec 7, 2020
Replies
1
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1,932
Feb 27, 2022
Alex Kennedy
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