03:59
Sanitation 21 CFR § 211.56 (Pharma Executive Series #22)
03:09
Washing and toilet facilities 21 CFR § 211.52 (Pharma Executive Series #21)
02:30
Sewage and Refuse 21 CFR § 211.50 (Pharma Executive Series #20)
03:06
Plumbing 21 CFR § 211.48 (Pharma Executive Series #19)
04:38
Ventilation, air filtration, air heating and cooling 21 CFR § 211.46 (Pharma Executive Series #18)
03:27
Lighting § 211.44 (Pharma Executive Series #17)
03:46
Design and Construction Features Part 2 § 211.42 (Pharma Executive Series #16)
03:36
Design and Construction Features Part 1 § 211.42 (Pharma Executive Series #15)
03:57
Consultants § 211.34 (Pharma Executive Series #14)
04:20
Personnel Responsibilities § 211.28 (Pharma Executive Series #13)
04:14
Personnel qualifications § 211.25 (Pharma Executive Series #12)
03:43
Responsibilities of quality control unit § 211.22 (Pharma Executive Series #11)
03:26
Scope § 211.1 (Pharma Executive Series #10)
02:45
Pharmaceutical cGMPs Definitions Part 6 - 210.3 & 211.3 (Pharma Executive Series #09)
01:39
Pharmaceutical cGMPs Definitions Part 5 - 210.3 & 211.3 (Pharma Executive Series #08)
03:07
Pharmaceutical cGMPs Definitions Part 4 - 210.3 & 211.3 (Pharma Executive Series #07)
03:01
Pharmaceutical cGMPs Definitions Part 3 - 210.3 & 211.3 (Pharma Executive Series #06)
02:46
Pharmaceutical cGMPs Definitions Part 2 - 210.3 & 211.3 (Pharma Executive Series #05)
03:52
Pharmaceutical cGMPs Definitions Part 1 - 210.3 & 211.3 (Pharma Executive Series #04)
03:42
Applicability of current good manufacturing practice regulations 210.2 (Pharma Executive Series #03)
04:11
Status of cGMP regulations Part 210.1 - (Pharma Executive Series #02)
03:51
Current Good Manufacturing Practices (cGMPs) 21 CFR § 21 CFR Part 210 & 211 (Pharma ES #01)
02:09
Pharmaceutical Executive Series Introduction Oct 2022
03:47
Site Acceptance Test (SAT) ISO 13485 § 7.5.6 (Executive Series #100)
02:54
Equipment Qualification ISO 13485 § 7.5.6 (Executive Series #99)
03:35
Design Qualification ISO 13485 § 7.5.6 (Executive Series #98)
07:26
CPP, CQA, & CtQ ISO § 7.3.4, 7.5.1, 8.2.5, & 8.2.6 (Executive Series #97)
03:59
Sterilization Families ISO 13485 § 7.5.6 & 7.5.7 (Executive Series 96)
04:02
Sterilization Revalidation – ISO § 7.5.6 and 7.5.7 (Executive Series #95)
03:56
Sterility Assurance Level (SAL) ISO § 7.5.2 & 7.5.7 (Executive Series #94)
05:18
Sterilization Overkill Methods ISO 13485 § 7.5.6 & 7.5.7 (Executive Series #93)
04:33
Pyrogens & Endotoxins ISO 13485 § 7.5.2 & 7.5.7 (Executive Series #92)
04:30
Parametric Release ISO 13485 § 7.5.6 & 7.5.7 (Executive Series #91)
03:51
Biological Indicators ISO 13485 § 7.5.2 & 7.5.6 (Executive Series #90)
04:07
Dose Audits ISO 13485 § 7.5.2 & 7.5.7 (Executive Series #89)
04:55
Bioburden Monitoring ISO 13485 §7.5.2 & 7.5.7 (Executive Series #88)
04:28
Aseptic Processing ISO 13485 § 6.3 & 7.5.2 (Executive Series #87)
03:55
Dry Heat Sterilization ISO 13485 & 7.5.7 (Executive Series #86)
03:52
Steam Sterilization ISO 13485 § 7.5.7 (Executive Series #85)
05:01
Ethylene Oxide Sterilization ISO § 7.5.7 (Executive Series #84)
03:29
Ebeam Sterilization ISO 13485 § 7.5.7 (Executive Series #83)
03:34
Radiation Sterilization ISO § 7.5.7 (Executive Series #82)
05:48
Medical Device Sterilization Validation ISO § 7.5.6, 7.5.7, & 820.75 (Executive Series #81)
05:07
Process Validation Worst Case Selection 820.75 & ISO 13485 § 7.5.6 (Executive Series #80)
06:10
Process Validation Traps 820.75 & ISO 13485 § 7.5.6 (Executive Series #79)
05:19
Process Validation Statistics 820.75 & ISO 13485 § 7.5.6 (Executive Series #78)
03:40
Process Validation Number of Validation Runs 820.75 & ISO 13485 § 7.5.6 (Executive Series #77)
04:06
Process Validation – Edge of Failure 820.75 & ISO 13485 § 7.5.6 (Executive Series #76)
04:06
Process Validation – Nominal Operating Range 820.75 & ISO 13485 § 7.5.6 (Executive Series #75)
04:06
Process Validation – Proven Acceptable Range 820.75 & ISO 13485 § 7.5.6 (Executive Series #74)
04:04
Process Validation Verification & Validation Deviations 820.75 & 13485 § 7.5.6 Executive Series #73
04:55
Process Software Validation 820.70i, 820.75 & ISO 13485 § 4.1.6, 7.5.6. (Executive Series #72)
05:48
Performance Qualification 820.75 & ISO 13485 § 7.5.6 (Executive Series #71)
05:08
Operational Qualification 820.75 & ISO 13485 § 7.5.6 (Executive Series #70)
05:13
Process Development 820.30h, 820.75, & ISO 13485 § 7.3.8 & 7.5.6 (Executive Series #69)
04:26
Master Validation Plan 820.75 & ISO 13485 § 7.5.6 (Executive Series #65)
04:03
Factory Acceptance Test (FAT) 820.75 & ISO 13485 § 7.5.6 (Executive Series #68)
04:26
Installation Qualification 820.75 & ISO 13485 § 7.5.6 (Executive Series #67)
04:46
Process Validation Protocols & Reports 820.75 & ISO 13485 § 7.5.6 (Executive Series #66)
04:16
Validation of sterilization processes & sterile barrier systems ISO13485 § 7.5.7 Executive Series 64
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Medical Device Quality Systems made simple in everyday language. This content is for anyone working in the medical device space. While the main focus may be medical device quality systems; the lessons, examples, and principals are useful in any regulated industry.
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We will cover the following topics: CAPA, Corrective and Preventive Action ,Corrective Action Preventive Action, Quality Audit, Internal Audit, FDA, FDA 483, Process Validation, Change Control, Design Controls, Management Controls, Risk Management, Purchasing Controls, Supplier Quality, and much more.
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Wayne "Aaron" Snyder has been working in the medical device industry for the last 16 years. Check out my Linkedin page for more information.
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