Changes to PIC/S GMP
What updates or changes to PIC/S GMP Guidance do you need to understand; and what is the latest version of PIC/S GMP Guidance and PIC/S Annexes?
Top 10 GMP Audit Citations: FDA & TGA Inspections
FDA & TGA GMP Compliance Audit Citations for 2020, 2021, & 2022. Latest FDA inspection trends: common audit…
Medical device Regulations (FAQs)
Medical device regulatory compliance FAQs: When is a product considered to be a medical device? What is meant by product classification system?
FDA Warning Letters on Data Integrity Issues
Batch release decisions — and other product safety evaluations — rely on data integrity. In this pharmaceutical industry…
PIC/s Annex 2A for ATMPs – GMP Regulation Updates
This article provides an introduction to the PIC/S Annex 2A updates in Version 15 in relation to Good…
Get ready for an Audit
Get ready for an audit (how to train your employees) Need to get ready for an audit? How…
Remote Inspections (Offsite Inspections): Auditing Guidelines
Procedures for Remote Inspections (virtual inspections) including ICT and Security Remote Inspections & Offsite Auditing Guidelines & Training…
Pharmaceutical Industry Jobs: 5 Essential Skills
What are the requirements for applying for pharmaceutical industry jobs? Are you applying for current Pharmaceutical industry job openings? If…
Cannabis Cultivation Training: 2 Convenient Options
Cannabis Sector Insights and Cultivation Training Cannabis Sector Speaker Presentations from the Global and Asia-Pacific Medicinal Cannabis Conference For…
Software as a Medical Device (SaMD)
FAQs about Software as a Medical Device (SaMD) Medical-purpose software development is a rapidly growing industry. As with…
Industry Updates: PDA and FDA Joint Regulatory Conference
Our GMP courses, e-learning courses and GMP Forums repeatedly get great reviews by people who need to know…
Does my product require FDA approval?
FDA Pre-Approval Requirements Will your product need pre-approval from the FDA before you can sell it to the…
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