PHARMACEUTICAL AUDIT & INSPECTION

CERTIFICATE TRAINING


Live Session

Certificate Awarded: Pharmaceutical GMP Audit and Inspection - Certificate

Time: 9.30 AM – 4.30 PM

Level of Training: Beginners | Intermediate

Mode of Delivery: Live Interactive Instructor-led Webinar

Date: June 19, 2021

Fee: $860

(Contact us for the Recorded webinar)

Webinar Overview

● GMP pharma audits/inspections is a critical function within a pharmaceutical company. It provides a quality management tool with information about how effectively the organization controls the quality of their processes, system and products and types of audits in the pharmaceutical industry.

● This online webinar on pharmaceutical auditor training includes a full range of audit preparation module that provides guidance in preparing for regulatory GMP inspections and is designed to provide broad fundamental industry knowledge for individuals that want to expand their GMP knowledge.

● Aspirants who want to become Internal auditors should attend this webinar on pharmaceutical auditing courses.

Course Offers

Register for 3 webinars at NACPT and get any available 1-day certificate training for free.

Pharmaceutical Audit & Inspection

  • Module 1
  • Introduction to Audit
  • ● Define an audit and explain why audits are carried out
  • ● Learn types and levels of audits
  • ● How to prepare for an audit
  • Module 2
  • Auditors
  • ● Explore auditors and skills
  • ● How to ask questions
  • ● Describe good listening skills
  • ● Review the importance of body language on the audit process
  • Module 3
  • Steps involved in successful audits
  • ● Review the Audit Timetable
  • ● Provide guidelines for Conducting the Audit
  • ● Discuss the importance of records and note-taking
  • ● Provide auditing tips and resources for auditors
  • Module 4
  • Post-audit activities and follow-up
  • ● Provide guidance for Exit Meeting preparation
  • ● Explore managing your findings
  • ● Explore attributes and considerations of a good report
  • ● Review follow-up activities and problem-solving tools
  • Module 5
  • Inspection points to consider during an audit
  • ● Review inspection points to consider in auditing
  • Module 6
  • Often forgot points
  • ● Gain awareness of points that may be missed during an inspection
  • Module 7
  • Preparing for Regulatory GMP Inspections
  • ● Preparing to host a regulatory GMP inspection
  • ● Preparing for activities during the inspection
  • ● Preparing for activities after the inspection
  • After successful completion of this course, students will be :
  • ● Able to perform internal audit and inspections
  • ● Able to conduct vendor or supplier audit
  • ● Able to investigate deviations
  • ● Able to produce audit reports
  • ● CAPA and change control review, tracking and implementation
  • ● Able to work with inspectors
  • ● Able to prepare for inspection
  • ● Able to respond to inspection comments
  • ● Able to perform an effective gap analysis
  • ● Auditors
  • ● Change Control Coordinators
  • ● QA Associates
  • ● QA Managers
  • Anyone who wants to become the following should attend the webinar on pharmaceutical auditor training:
  • ● Beginners level auditors or individuals wanting to become auditors.
  • ● Individuals with few years of experience working with the GMP/ICH guidelines who want to develop additional expertise in GMP Auditing.
  • ● Internal auditors/audit teams
  • ● Suppliers and companies who are audited

Gmp Pharma Audits / Inspections | Pharmaceutical Audit | Pharmaceutical Auditing Courses Pharmaceutical Auditor Training | Types of Audits in Pharma Industry | Types of Audit in the Pharmaceutical Industry

Prof. Naheed Kausar

M.Sc., Chemistry

 

With 19 years of quality control/ quality assurance experience in the pharmaceutical industry and an M.Sc. in Chemistry, Naheed Kausar has joined the North American College of Pharmaceutical Technology in 2013. She is heading the Regulatory Affairs, GMP, GCP, GLP, GDP courses and teaching students to handle industry regulations with care. Her expertise in the technical and regulatory divisions of pharmaceutical companies helps students to understand the need of the regulatory body and compliance of the companies.

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