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Pharmaceutical Quality Assurance Certification

PROGRAM OVERVIEW

NAI’s Pharmaceutical Quality Assurance Certificate Program provides knowledge and insight into the Quality Department of pharmaceutical and allied industries, with a focus on Quality Assurance and cGMP. At the end of this program, learners will understand the US-FDA and other global regulatory agencies (Health Canada and European) compliance requirements. A comprehensive and in-depth knowledge of current Good Manufacturing Practices (cGMP) and other quality concepts and standards such as validation, stability, auditing, change control, non conformities, CAPA, complaints and recalls will be delivered in this program.

Internal and
Regulatory Audits

Quality Assurance in companies involved with manufacturing and quality control of therapeutics must understand US FDA and global regulatory requirements for: auditing, responsibilities of the auditor, the audit process and application of audit practices. The result of an audit can greatly impact an organization’s reputation to sell products and expand product lines.

Our training offers a variety of methods from theory to practical workshops to give learners a solid knowledge of regulatory requirements and quality standards as well as the ability to carry out in- depth audits of quality systems in the pharmaceutical industry.

Technical Writing and Good Documentation Practices

Technical writing is crucial for generating quality related documents such as Standard Operating Procedures (SOPs), Change Control Forms, Deviation Reports, Audit Response Letter and more. And a solid GDP sets a standard guidance for all employees to adhere, which leads to reduction in errors, defects, recalls, non-compliance – ultimately protecting the organization’s bottom line.

Our technical hands-on training takes learners through the best standard documentation ractices as well as drafting technical documents that are used for day-to-day operation at any pharmaceutical company.

cGMP

FDA mandates cGMP regulations “for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product”. These regulations are enforced with all drug anufactures to ensure products are safe – free from contaminates and correct label claims. Understanding cGMP regulations and implementing strategies to aintain compliance is critical for the survival of any pharmaceutical company.

Our Quality Assurance certificate program emphasize on designing and implementing an effective Quality Management Systems (QMS) to comply with ever-evolving cGMP regulations.

Admission Requirement:

Course Length

  • Quality Assurance Associate
  • Quality Assurance
  • Technician
  • Document Reviewer
  • Quality and Compliance Specialist
  • Analytical Chemist
  • Laboratory Analyst
  • Laboratory Technician

We developed strong partnerships with industry-leading companies in pharmaceutical and clinical field. We work directly with these organizations to provide opportunities to our graduates.

Our online learning environment gives students the option to learn completely at their own pace, anywhere and at any time of the day. Learners will have access to our subject matter experts who are there to provide support and answer any subject related questions.
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