Pharmaspecialists.com

Submission of eCTD Sequence to Health Canada

WEBFollowing steps are required before submitting the first eCTD sequence: 1. Obtain regulatory transaction description from Agency. The Excel sheet for different …

Actived: 1 days ago

URL: https://www.pharmaspecialists.com/2023/02/submission-of-ectd-sequence-to-health-canada.html

First Aid Safety in Pharmaceutical Industry

WEBAugust 10, 2023. First aid safety is crucial in the pharmaceutical industry to ensure the well-being and rapid response to any medical emergencies that may arise. In this sector, …

Category: Medical Go Health

Health and Safety Tools in Pharmaceutical Industry

WEBHealth and Safety Tools in Pharmaceutical Industry. September 13, 2023. Health and safety tools are essential for maintaining a safe and healthy work …

Category: Health Go Health

Quality Risk Management (QRM) in Pharmaceutical Industry

WEBJanuary 11, 2022. In pharmaceutical industry, QRM is a systematic process for the assessment, control and review of risks to the quality of the drug product.It is the overall …

Category: Health Go Health

Pharmaceutical Products Recall Guidelines and Procedures FDA

WEBPharmaceutical Products Recall Guidelines and Procedures | FDA. Recalls are an effective method for removing or correcting marketed products, their labeling, …

Category: Health Go Health

Clinical Pharmacist vs Hospital Pharmacist

WEBClinical Pharmacist. 1. Clinical pharmacist is a health care professional, who is more concern about the ways of administration, patterns of use and drugs effects on …

Category: Health Go Health

Pharmaceutical Terminology (Part-1)

WEBPharmaceutical Terminology (Part-1) Absolute Advantage. is the ability of a country, individual, company or region to produce a good or service at a lower cost per unit than …

Category: Health Go Health

Good Manufacturing Practices : WHO Guidelines on Validation

WEBThe need for revision of the published World Health Organization (WHO) Supplementary guidelines on Good Manufacturing Practices: Validation was identified …

Category: Health Go Health

Human Errors in Pharmaceutical Industry bGMP

WEBMust consider: – Unintentional errors. – Risky behaviour. – Reckless behaviour. Atrisk behaviour is when the person believes the benefit of NOT complying …

Category: Health Go Health

Types of FDA Regulatory Submissions

WEB505 (b) (2) NDA: This is for a drug manufacturer that can rely, in part, on data that has already been established for an approved drug product. Supplemental …

Category: Health Go Health

FEFO and FIFO in Pharmaceutcal Industry

WEBJune 14, 2023. FEFO/FIFO is a technique for managing loads that aims to supply products (to make them flow through the supply chain) by selecting those closest to expiration …

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CBE-0, CBE-30 and PAS Submission in ANDA

WEBThe company can submit a CBE-30 notification to the FDA, informing them of the change at least 30 days before distributing the product with the new packaging. If the …

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Pharm D Syllabus in USA

WEBPharm D Syllabus in USA. March 11, 2022. The DOCTOR OF PHARMACY (PharmD) degree is a broad undifferentiated degree attesting to general knowledge in …

Category: Health Go Health

List of Stringent Regulatory Authorities (SRA)

WEBThe national drug regulatory authorities which are members or observers or associates of the International Conference on Harmonization of Technical Requirements …

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GMP Audit Checklist for Pharmaceutical WHO Guideline (Part-1)

WEBAdministration. Full address of the company. Inspection type : routine/ internal/ external/ follow-up etc. Facility/Department bieng inspected. Types and list of …

Category: Health Go Health

List of Regulatory Authorities

WEB4. Malaysia - National Pharmaceutical Regulatory Agency (NPRA) 5. Saudi Arabia - The Saudi Food & Drug Authority (SFDA) 6. UAE - The UAE Ministry of Health …

Category: Food Go Health

Health Canada Guidance on Nitrosamine Impurities

WEBMay 02, 2023. This guidance represents Health Canada’s current thinking and recommendations on issues related to N-nitrosamine impurities (nitrosamine …

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Pharmaceutical Regulatory Affairs Interview Questions and Answers

WEBQ1. What is Regulatory Affairs? Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry …

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Innovative Ideas in Pharmaceutical Marketing

WEBPharmaceutical marketing refers to the strategies and activities that pharmaceutical companies undertake to promote their products, which include …

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