Importance of Audit in Pharmaceutical Industry:
International Organization for Standardization (ISO) 9000 requirements do not have the same status of “the law” in the U.S. as do requirements listed in the Code of Federal Regulations (CFR). Because 21 CFR 210 and 211 have legal status, the U.S. Justice Department has extensive powers to ensure compliance. For example, product in the marketplace can be seized, fines can be levied, and personal liability can be assigned. So, management must understand that auditing must be taken seriously, and the requirements listed are just that – requirements. While audits are the common place in the pharmaceutical industry, the preparedness for those events varies. The companies that develop a risk-based approach to audits are able to remain competitive while meeting quality and government compliance standards on a regular basis. Conversely, the companies that have not implemented strong processes are putting themselves at risk for non-compliance. According to the Federal Food, Drug and Cosmetic Act, “Registered domestic drug establishments shall be inspected by the FDA at least once every two years.” Under some conditions the inspections may be even more frequent, As regulations become more stringent, regulatory authorities are likely to step up audits which is even more reason for companies to be prepared.
- Quality control plans
- The Audit as a Quality Control Mechanism
- Adequate supervisory control
- Proper administration of a benefit plan
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Importance of Audit in Pharmaceutical Industry: Conference Speakers
Recommended Sessions
- Active Pharmaceutical Ingredients:
- Analytical strategies for pharmaceutical products:
- Biologics and Biosimilars :
- Clinical trials and Pharmacovigilance:
- Drug Delivery Technologies & Drug Designing and Development:
- Drug discovery and NCEs:
- Formulations and NNDS:
- Good Manufacturing Practices (GMP):
- Importance of Audit in Pharmaceutical Industry:
- Pharma Market Research:
- Pharmaceutical Auditing for OTC Drugs:
- Pharmaceutical Industry:
- Pharmaceutical Manufacturing, Scale Up and Tech transfer:
- Pharmaceutical Nanotechnology: Challenges and Opportunities:
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- Pharmaceutical Research and Development:
- Pharmacoeconomics:
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- Regulatory Affairs:
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- Smart Drug Delivery Systems - Pharmatech 2025 (Canada)
- Smart Drug Delivery Systems - Formulations 2025 (France)
- Smart Drug Delivery Systems - PHARMACEUTICA 2025 (Germany)
- Smart Polymers for Drug Delivery - Pharmaceutica-2025 (Canada)
- Solid Dosage Forms - Formulations 2025 (France)
- Stem Cell and Genetic Clinical Research - Clinical Research 2025 (Netherlands)
- Sustainability and Global Health Biotechnology - Biotech-2025 (France)
- Synthetic and Bioorganic Chemistry - PHARMACEUTICAL CHEMISTRY 2025 (Italy)
- Targeted Drug Delivery and Controlled Release Systems - PHARMA CONFERENCE-2025 (France)
- Targeted Therapies - Personalizedmedicine-2025 (Switzerland)
- Targeted Therapies in Cardiovascular Regeneration - Cardiovascular-2025 (France)
- Targeting the Renin-Angiotensin-Aldosterone System (RAAS) - Cardiovascular-2025 (France)
- Technology in Pharma Sciences - MedTech-2025 (Switzerland)
- Telemedicine - Personalizedmedicine-2025 (Switzerland)
- The Future of Pharma R&D - Future Pharma 2025 (Netherlands)
- The Next Generation Approach of Antibiotics - Antibiotics Resistance 2025 (Canada)
- Toxicology - Pharmacology 2025 (France)
- Translational Research - Personalizedmedicine-2025 (Switzerland)
- Types of Formulations - Formulations 2025 (France)
- USFDA Approved Biosimilars - Eurobiosimilars 2025 (France)
- Vaccine Delivery Systems - Pharmaceutica-2025 (Canada)
- Vaccine Design and Drug Design - PHARMA CONFERENCE-2025 (France)
- Vaccine Drug Delivery Systems - PHARMACEUTICA 2025 (Germany)
- Vascular Pharmacology: Focus on Endothelial Dysfunction - Cardiovascular-2025 (France)
- Wearable Drug Delivery Systems - PHARMA CONFERENCE-2025 (France)