Executive Development Programme in PharmaTech Regulations and Compliance
-- ViewingNowThe Executive Development Programme in PharmaTech Regulations and Compliance is a certificate course designed to empower professionals with the necessary expertise in regulatory affairs and compliance within the pharmaceutical and healthcare industries. This programme is crucial in today's context, where stringent regulations and rigorous compliance requirements are shaping the PharmaTech landscape.
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⢠PharmaTech Regulations Overview: Understanding the legal and regulatory framework governing the pharmaceutical technology industry, including key regulations and compliance requirements.
⢠Quality Management Systems (QMS): Implementing and maintaining a QMS according to international standards, such as ISO 13485 for medical devices and cGMP for pharmaceuticals.
⢠Regulatory Affairs: Managing regulatory affairs, including registration, variations, and renewals, to ensure compliance with local and international regulations.
⢠Good Laboratory Practices (GLP): Adhering to GLP principles to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of test data.
⢠Good Clinical Practices (GCP): Compliance with GCP principles to ensure the protection of the rights, safety, and well-being of human subjects involved in clinical trials.
⢠Good Manufacturing Practices (GMP): Compliance with GMP principles to ensure the proper design, monitoring, and control of manufacturing processes and facilities.
⢠Pharmacovigilance: Implementing and maintaining a pharmacovigilance system to monitor, assess, and report adverse events and reactions.
⢠Data Integrity: Ensuring data integrity throughout the entire product lifecycle, from research and development to manufacturing and post-market surveillance.
⢠Risk Management: Implementing and maintaining a risk management system to identify, assess, and mitigate risks in all aspects of the product lifecycle.
⢠Audit and Inspection Preparedness: Preparing for and managing audits and inspections by regulatory authorities, including internal and external audits.
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