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Karl Fischer Titration Week – Webinar Series & Expert Roundtable (On demand webinar)
|
Merck Supelco |
19 Jun 2023 |
Webinar (On Demand) |
Free |
|
OTC Monograph Reform: OMOR Format and Content & Electronic Submissions
|
FDA &SBIA |
22 Aug 2023 |
Virtual Seminar |
Free |
|
Understanding FDA Inspections and Data
|
FDA & SBIA |
06 Sep 2023 |
Webinar |
Free |
|
Secondary standards - Considerations in traceability to pharmacopeial standards
|
EDQM USP Joint Webinar |
10 Oct 2023 |
On Demand Webinar |
Free |
|
Reference Standard Management for Pharmaceutical Development
|
XTalks and MRIGlobal |
09 Jan 2024 |
Webinar |
Free |
|
Environmental Monitoring Compliance Learning from FDA Warning Letters
|
PMS - Particle Measuring Systems |
21 Feb 2024 |
On Demand Webinar |
Free |
|
Ethylene glycol and diethylene glycol testing - Joint EDQM-USP webinar
|
USP & EDQM |
18 Apr 2024 |
Webinar |
Free |
|
How to facilitate your acceptable intake limit setting for nitrosamines
|
Lhasa |
25 Apr 2024 |
Webinar |
Free |
|
Identifying the formation of nitrosamines via degradation pathways using an in-silico approach
|
Lhasa |
24 Apr 2024 |
Webinar |
Free |
|
USP 621 Harmonization - Method Scaling
|
Waters |
14 May 2024 |
Webinar |
Free |
|
Monitoring Compressed Gases for Microbial and Particle Contamination
|
American Pharmaceutical Review & PMS |
15 May 2024 |
Webinar |
Free |
|
USP Standards to Support the Characterization of mAbs
|
USP & Biopharm Int |
13 Jun 2024 |
Webinar |
Free |
|
Mastering 505(b)(2) Development Strategy
|
X Talks & Premier Consulting |
18 Jun 2024 |
Webinar |
Free |
|
Environmental Monitoring vs Good Aseptic Technique
|
Particle Measurement Systems |
01 Aug 2024 |
On Demand Webinar |
Free |
|
Visual Inspection Defects in Oral Solid Dosage Forms: Trouble shooting
|
ISPE |
17 Dec 2024 |
Webinar |
Free |
|
Smoke Studies and Sterility Assurance
|
Particle Measurement Systems |
22 Jan 2025 |
Webinar |
Free |
|
Improving Content Uniformity of Morphologically Challenging APIs by Excipient Choice
|
Pharmaceutical Technology |
14 Jan 2025 |
Webinar |
Free |
|
Nitrosamines: Occurence, Chemistry and Current Analytical Trends
|
Elemental Lab Solutions & LCGC |
20 Feb 2025 |
Webcast |
Free |
|
Understanding Current Regulatory Thinking on Contamination Control Strategy (CCS)
Designing an effective contamination control strategy (CCS), CCS before EU Annex 1 and after, Case studies, FDA 483observations on CCS presented by expert Ziva Abraham #Contamination control,
#Microbial Controls,
|
EPR |
20 Feb 2023 |
Webinar |
Free |
|
From Ambiguity to Action: The FDA’s New Nitrosamine Guidance
Explore FDAs newly finalised guidance for Nitrosamines; established and emerging techniques to reduce nitrosamine and NDSRI formation, alternative strategies for reducing nitrosamines |
Adare Pharma Solutions |
03 Dec 2024 |
Webinar |
Free |
|
Legal Considerations | Interacting with the FDA Before, During, and After Inspections
Legal concept of FDA inspection, how evidence of the violations may be used for legal enforcement, how to interact with FDA before, during and after inspection by Neil DiSpirito, FDA law partner |
Redica Systems |
23 May 2023 |
Webinar |
Free |
|
Quality Intelligence: from Information to Knowledge
Webinar by former FDA investigator Peter Baker. Cover PIC/S guidance, data management, and demonstrating knowledge management during an inspection |
Redica Systems |
30 May 2023 |
Webinar |
Free |
|
AI in GxP:Â Opportunities, Challenges and Industry Guidance
Insights on current AI trends, EMA & FDA guidance, EU AI Act & legal framework for AI, Use of AI in regulatory decision-making, Validation AI-enabled systems, case studies |
KENX |
19 Mar 2025 |
Podcast Q&A Session |
Free |
|
Overcoming Obstacles in Establishing Pharmacopoeial Reference standards
Discusses real world challenges in developing reference and working standards with case studies -Potency by mass balance, Purity by NMR, Insufficient assessment, Undetected impurities |
EDQM & USP |
10 Oct 2024 |
Webinar |
Free |
|
2023 EDQM virtual training programme - Module 8: EDQM Inspections Programme
Discusses how inspections of API manufacturers are organised, how to prepare for inspections. Also discusses nature of GMP violations observed during recent years #GMP Inspections,
|
EDQM |
07 Jul 2023 |
Webinar |
Free |
|
2023 EDQM Virtual Training Programme - Module 3: Impurity Control in the Ph. Eur
Learn about Ph. Eur. Policy on Impurity controls – organic, inorganic, elemental, solvents, nitrosamine impurities, link between individual and general monographs, implementation of ICH guideline requ #Impurity controls,
|
EDQM |
29 Jun 2023 |
Webinar |
Free |
|
2023 EDQM Virtual Training Programme - Module 4: Ph. Eur. reference standards
Discusses CRS (Chemical Reference Standards), how standards are established, their use and handling, expectations of GMP inspectors on reference standards |
EDQM |
29 Jun 2023 |
Webinar |
Free |
|
2023 EDQM Virtual Training Programme - Module 7: Control of impurities: CEP approach
Discusses how to control impurities in active substances for CEP, develop control strategy for organic, inorganic, elemental, solvent and mutagenic impurities with examples and regulatory req #Impurity controls,
|
EDQM |
06 Jul 2023 |
Webinar |
Free |
|
An Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR)
An Indepth session on FAR and BPDRs – Difference between FARs and BPDRs, Complaints, expectations of FDA, Case study, How FDA uses this in Site Selection Model (SMM) and Quality System assessment #FAR,
|
FDA & SBIA |
24 May 2023 |
Webinar |
Free |
|
pH Basics - Glass Electrode, How it measure pH, Calibration, Till when one can use
Video on design of standard glass electrode (pH sensor), glass electrode as a battery generating voltage due to pH of sample, measurement vs reference electrode, zero point shift, slope, calibration |
Hamilton |
16 Mar 2025 |
Video |
Free |
|
CCS: Establishing a Facility Isolate Program Based on Microflora Trending
Facility isolate programme based on microflora trending, significance of local isolates, how to ensure detectability of likely contaminants in environment, utilities, processes Applicable regulations #Containment control,
#Environmental Monitoring,
#Microbial Controls,
|
American Pharmaceutical Review |
22 Jan 2025 |
Webinar |
Free |
|
Disinfectant Efficacy Testing on Site Specific Surfaces
Thie webinar discusses the principles in USP <1072> Disinfectants and Antiseptics and their application to reduce microbial contamination, sanitisation of surfaces, in-vitro evaluation and testing #Containment control,
#Microbial Controls,
|
Nelson Labs |
24 Mar 2024 |
Webinar |
Free |
|
When is Sterility Testing Appropriate
Discusses Sterility Assurance through Sterilization and Packaging validations, Review Sterility testing, Methods, when & how testing be applied, when testing is not appropriate to determine sterility #Aseptic operation,
#Sterile process controls,
#Sterility,
|
Nelson Labs |
08 Mar 2024 |
Webinar |
Free |
|
Best Practices in Commissioning and Qualification
Discusses ways to address the gap between Commissioning and Qualification (C&Q) to ensure facilities, systems, utilities, and equipment align with their intended purpose, with practical insights #Equipment Qualification,
|
Valgenesis |
15 Feb 2024 |
On Demand Webinar |
Free |
|
Analytical QbD for OTC Products
Discusses analytical quality by design (aQbD) for developing flexible methods suitable for various excipient concentrations and formulations with chromatographic ranges instead of fixed conditions #Method Validation,
|
Waters |
06 Aug 2024 |
Webinar |
Free |
|
Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products
Discusses regulatory recommendations on testing methods, formation of NDSRIs, detecting their formation, strategies to mitigate risks of their formation, approaches for pre- and post- approval changes #NDSRI,
#Nitrosamines,
|
USFDA & CRCG |
06 Nov 2024 |
Workshop |
Free |
|
Cleaning and Disinfection in Sterile Drug Manufacturing
Discusses Regulatory expectations (EU Annex 1) on Cleaning and disinfection, Contamination control strategy, Risk-based determination of frequency, methodology, chemistry, and cleaning #Containment control,
#Sterile process controls,
|
Pharmatech & Veltek Associates |
15 May 2024 |
Webinar |
Free |
|
Continuous Monitoring & Building Management Systems
Discusses monitoring in GxP buildings, two type of systems CMS vs BMS and Network iagrams, purpose of the systems, Pros & Cons and efforts on validating the systems, Lifecycle & System adaptability #Environmental Monitoring,
#BMS,
#EMS,
|
ISPE & VAISALA |
31 Jan 2024 |
Webinar |
Free |
|
Regulatory Requirements for Injectable Packaging: Whats New and What to Do
Discusses regulatory updates for injectable packaging, requirements for Elastomeric closures, physiochemical, biological, functionality requirements, USP 381, 1381, USP 382, 1382, Timelines #Specifications,
#CCS,
|
Pharmaceutical Technology & Datwyler |
04 Jun 2024 |
Webinar |
Free |
|
Deep Dive into Container Closure Integrity (CCI)
Essential factors, requirements USFDA, EU Annex 1, USP<1207>, <382>, Probabilistic vs Deterministic methods, Dye Ingress, High Voltage Leak Detection (HVLD), Helium Leak Test (HLD), Laser Head Space #CCI,
#Packing,
|
Pharmaceutical Technology & Datwyler |
02 Oct 2024 |
Webinar |
Free |
|
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024
Overview on FDA Drug, OTC registration and listing requirements, who must register and list, demonstration of establishment registration submission using CDER direct, NDC number format and segments #Establishment Registration,
#NDC,
|
USFDA CDER |
12 Sep 2024 |
Conference |
Free |
|
Empower Tips: Using and Reviewing Information in Empower Software Audit Trails
Various Audit Trails within Empower Software, Message Center for instrument and processing errors, demonstration of Empower Result Audit Viewer. System, Project, Method, Sample, Sample Set Audit Trail #Electronic Data Control,
|
Waters |
30 Apr 2024 |
Webinar |
Free |
|
GC Troubleshooting in 20 Pictures - Part 2
Real life chromatograms and baselines are used to illustrate key issues with GC – impure carrier and detector gases, poorly maintained sample inlets, poorly installed columns, detector issues, & more |
LCGC |
13 Dec 2024 |
Webinar |
Free |
