FDA Audits

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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Jul
18

Who conducts GMP audits in pharmaceutical manufacturing and other therapeutic goods production?

Who regulates GMP compliance? In today’s article supporting the GMP Basic Training blog series, we’ll answer questions relating to “who regulates compliance GMP?”  We’ll provide a brief overview and list of Regulatory Authorities in GMP industries, who’s representatives: monitor manufacturing practices (and safety, efficacy and other quality standards) for medicinal products distributed in their regions […]

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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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