| Date | Potent Compound Series | |
| 202312 | Are Toxicologists Certified <More...> | |
| 202301 | An OEL from another source, such as a SDS, that is different than the one on the OEL document from professional provider. Which one is correct? <More...> | |
| 202212 | The equations for both the OEL and ADE seem pretty simple. Can’t I do the literature searches and calculations myself? <More...> | |
| 202211 | When do you need an OEB vs. an OEL? <More...> | |
| 202210 | Dos and Donts of OELs and ADEs <More...> | |
| 202209 | What is Chemical Abstracts Service Registry Number(CASRN)? <More...> | |
| 202206 | What determines if a compound has hormonal activity and are all hormonal compounds highly potent? <More...> | |
| 202205 | What is driving the increase in HPAPI products? <More...> | |
| Date | Cross-contamination Series | |
| 202403 | Aseptic Manufacturing Practices <More...> | |
| 202312 | How to create CCS <More...> | |
| 202311 | EU QP EU GMP Annex 1 CCS FQAs 2020 <More...> | |
| 202310 | PDA Letter CCS You Have Questions We Have Answers 2021 <More...> | |
| 202309 | ECA Attachment 1 Example of a Gap Assessment <More...> | |
| 202308 | ECA Attachment 3 Template for The Contamination CCS Document (example) <More...> | |
| 202307 | ECA How to Developement CCS <More...> | |
| 202305 | ASTM E3219 Derivation of HBELs <More...> | |
| 202304 | ASTM E3106 Science and Risk Based Cleaning Process Development and Validation <More...> | |
| 202209 | Non-penicillin beta-lactam drugs for preventing cross-contamination <More...> | |
| 202207 | Cross-contamination in Shared Facilities Guidance by PIC/S goes into force July 1st, 2018 <More...> | |
| Date | Track&Trace Series | |
| 202406 | EU MAH on FMD Related Responsibilities <More...> | |
| 202311 | EMVS Q&A 4 Technical on-bording (Safety features) <More...> | |
| 202306 | EMVS Q&A 5 Maintenance (Safety features) <More...> | |
| 202210 | EMVS Q&A 6 Data Upload (Safety features) <More...> | |
| 202208 | EMVS Q&A 7 CMO and 3PL Connection (Safety features) <More...> | |
| Date | CCI Series | |
| 202404 | CCIT—Practical Aspects and Approaches in the Pharmaceutical Industry <More...> | |
| 202303 | CCIT- Why Industry Cannot Just “Move Away" from the Dye Ingress Test <More...> | |
| Date | Investigation Series | |
| 202411 | How do you write a regulatory-acceptable deviation investigation report <More...> | |
| 202410 | FDA Updates Guidance For Investigating OOS Test Results for Pharma Production <More...> | |
| 202409 | FDA Form 483 Irregularities in the handling of personnel and changing <More...> | |
| 202408 | FDA Form 483 Inadequate Training of Visual Inspectors <More...> | |
| 202408 | FDA Form 483 Observations of CCTV Data Review <More...> | |
| 202407 | 2006-2022 FDA Form 483 Analysis and Top 10 Common Observations <More...> | |
| 202405 | Top 10 DI citations in production systems <More...> | |
| 202404 | A fresh look at an old topic Investigations in the GMDP environment <More...> | |
| 202402 | Do You Make These 8 Big Mistakes In Your Deviation Investigations <More...> | |
| 202401 | Deviation FAQs <More...> | |
| 202308 | The Moldy Nightmare Questions and Answers, Part 1 <More...> | |
| Date | Other Series | |
| 202411 | What does the FDA mean by CGMP <More...> | |
| 202407 | Contract Manufacturing Arrangements for Drugs Quality Agreements <More...> | |
| 202406 | Which Batch Size for Validation and Stability Studies? <More...> | |
| 202405 | EU MAH GMP Guidance <More...> | |
| 202403 | EU GMP Annex 11 concept paper on revision 2022 <More...> | |
| 202402 | Quality culture A top-down culture <More...> | |
| 202401 | What exactly is Quality Culture <More...> | |
| 202309 | EMA FAQs of GMDP <More...> | |
| 202302 | Top 10 in 2022 <More...> | |