46:14

Toxicological Safety Assessment of Process Equipment-Related Leachables in the context of USP (665)

29:33

Good Identification Practices in Non-Targeted Screening Analyses

27:24

Assuring Viral Safety of the Biopharmaceutical Process

33:58

Potential Designs for Leachable Studies on Biopharmaceutical Manufacturing Equipment

34:26

Extractables Testing of Bioprocessing Materials

38:39

Assisting Companies in the Qualification of Single-Use Materials

53:05

USP 665 and 1665 Extractables for Components in Pharmaceutical and Biopharmaceutical Manufacturing

31:23

Leachable Risk Assessment Approaches:

25:38

Qualification of Single Use Materials for Biopharmaceutical Manufacturing

26:11

Challenge for Industry with new USP (665) / (1665)

28:51

Impact of radiation sterilization on single-use products

32:07

Cytiva Approach for E&L Qualification and Risk Assessment of a Single-Use System: Case Studies

33:14

Considerations for Validation of Filters used in (Bio)Pharmaceutical Manufacturing

29:20

E&L from Single-Use Systems and Their Assessment in Advanced Therapy Medicinal Product production

35:50

USP (665) Focus on Component Qualification – What About Component Selection?

45:09

Unmasking the unknown how mass spectrometry delivers accurate identifications

20:29

USP (665) survey – insights and results

36:56

Updates to ISO-18562:2024 - A CRO Point of View

53:06

History & Modern Practices for ASTM E1174: Evaluating the Effectiveness of Handwash Formulations

01:00:03

DAY 3 - Toxicological Considerations of VH2O2 Sterilization Residuals

59:18

DAY 2 - Considerations for Biocompatibility

01:00:12

DAY 1 - VH2O2, Sterilization Considerations

03:49

Intro E&L- and Safety Considerations for Disposable Biopharmaceutical Manufacturing Equipment.

55:11

How QMS Impacts Quality Maturity

10:24

Handling Unexpected Biocompatibility Test Results in Medical Device Development

34:51

The Fight Against Viruses: The Importance of Cleanroom Virus Disinfection Validations

39:29

Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol

01:01:36

Biocompatibility Testing, What You Need to Know

01:00:09

Advancing Microbial-Contamination Detection Through Rapid Sterility Testing

01:03:44

What’s New with Reprocessing Validations for Reusable Medical Devices

43:34

Disinfectant Efficacy Testing on Site Specific Surfaces

48:27

Biocompatibility as a Critical Design Input

36:44

Biocompatibility as a Critical Design Input

25:43

How to design an Instruction For Use and validations for EU and US

39:48

The Impact of Physico-chemical Properties of Extractable Compounds on Their Analytical Responses

25:34

A risk based approach towards the assessment of process equipment related leachables - case study

58:13

Single-Use Endoscopes: Critical Safety and Regulatory Considerations for Manufacturers

58:18

What Really Changed: A Look at the Updated FDA Guidance Document for ISO 10993-1

48:05

Package Validations – Meeting the Requirements of ISO 11607

49:19

The Impacts of Updated Standards on IFU Validations for Reusable Medical Device

38:27

Meeting New Challenges in Toxicological Risk Assessment: Pending Updates to ISO 10993-17

29:25

Medical Device Chemical Characterization

31:10

Using the Chemistry of Halogenated Rubber Oligomers in Identifying Unknowns in Extractables Studies

24:49

Perform cleaning validations of reusable medical devices after publication of ANSI_AAMI ST98:2022

01:06:00

Packaging related nitrosamines in Drug Products

48:01

Container Closure Requirements: Preparing for USP 382, 661.1, & 661.2

46:41

What Makes a Successful ISO 18562 Toxicological Risk Assessment?

58:46

Biofilm in Health Care Products – Key Considerations in Biofilm Management

01:01:13

How Should Disinfection Validations be Performed for Reusable Medical Devices?

01:01:09

A Basic Overview of Sterilization Validations (Reusable Medical Devices)

01:01:40

A Complete Guide to Cleaning Validations (Reusable Medical Devices)

18:48

NVR Reconciliation – Expectations versus Reality

26:21

Designing a Biocompatibility and Chemical Characterization Strategy

40:47

Looking into the Future of Extractable testing to support Chemical Characterization

34:54

Approaches in the Quantitation Strategy for Results of a Non-Targeted Screening Analysis

01:01:31

Container Closure Integrity Testing (CCIT) for Pharmaceutical Sterile Barrier Packaging

25:03

Good Identification Practices in Non-Targeted Screening Analyses

36:03

Antimicrobial Treatments, Finishes and Surfaces – Understanding Testing Options

30:49

Viral Clearance: Removal of Viral Contamination in Biopharmaceutical Manufacturing

59:24

Developing Contamination Control Strategy