FDA Audit

Jun
18

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 Manufacturing Practice (GMP) requirements for Advanced Therapy Medical Products (ATMPs). PIC/s guidance on ATMPs and biological medicines: what changed in PIC/S Version 15? GMP requirements for the production of ATMPs (in Annex 2A) are now in a […]

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May
27

Get ready for an Audit

Get ready for an audit (how to train your employees) Need to get ready for an audit? How do you ensure your organisation is ready for an audit? Do your employees know how to properly respond to an Auditor’s questions? Or was your last mock GMP audit (or internal quality audit/self-inspection) a disaster? If you’re […]

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May
17

Auditing FAQs: Guidelines for Offsite Inspections

Procedures for Remote Inspections (virtual inspections) including ICT and Security Auditing Guidelines and Auditor Training Courses 10 Commandments for Conducting Remote Audits and offsite inspections Auditing FAQ’s about Remote Auditing guidelines, remote auditing techniques and procedures FAQ 1: Are remote inspections as effective as onsite inspections when evaluating GMP compliance? The success of a remote […]

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Apr
12

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 yes, there are 5 essential skills you’ll need to develop to be successful in your employment. The pharmaceutical sector includes medical device manufacturing, biologic medicines, veterinary medicines, medicinal cannabis cultivation and production, and certain nutritional supplements and […]

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Nov
30

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 those of you who missed the world-class Australian Medicinal Cannabis Conference (#AMCC) in 2020, there are two (2) options available to you, your potential investors, and your operational teams in need of cultivation training expertise and regulatory […]

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Oct
27

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 other medical devices, medical-use software offers potential benefits to patients. SaMD can save lives by improving diagnostic capacities, monitoring treatment efficacy, and guiding critical-care decisions. Review the online GMP compliance course for SaMD designers, medical-use software manufacturers […]

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Oct
21

Top 10 GMP Audit Failure Reasons: FDA and TGA Inspection Findings

Preparing for GMP/PICS Audits by TGA or FDA Inspectors can be a time for introspection. An upcoming GMP audit can even provide inspiration for initiating a continuous improvement initiative, perhaps discussed for months or years yet not yet implemented. So pre-audit preparation is all about focusing on actions, rather than endless discussions. Yet TGA and […]

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Sep
19

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 the latest PDA and FDA information on regulatory requirements, compliance inspection findings, and GMP compliance audit trends…why is that the case? It’s because our GMP training course experts and quality/risk management compliance consultants regularly attend the top […]

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Aug
06

Does my product require FDA approval? FDA Pre-Approval Requirements

How can you tell if your product needs pre-approval from the FDA before you can market it to the public? This blog gives you a general idea of the types of products and additives that require pre-approval from the FDA prior to marketing (going to market). You’ll need to consult the FDA and visit the […]

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