TGA (Therapeutic Goods Administration) Compliance Training

Overview:

Pertecnica Engineering is a premier institute offering specialized corporate training programs tailored to meet the rigorous demands of the pharmaceutical sector. Our TGA (Therapeutic Goods Administration) Compliance Training course is designed to provide professionals with in-depth knowledge and practical skills necessary to navigate the complex regulatory environment in Australia. This course is ideal for quality assurance managers, regulatory affairs professionals, compliance officers, and others involved in ensuring that pharmaceutical products meet TGA standards.

Course Objectives:

  • Understand the role and functions of the TGA in regulating therapeutic goods.
  • Gain detailed knowledge of TGA regulations, guidelines, and compliance requirements.
  • Develop skills to prepare and submit product registrations, variations, and renewals.
  • Learn about Good Manufacturing Practices (GMP) and quality assurance in the context of TGA compliance.
  • Equip participants with the ability to manage audits, inspections, and regulatory submissions effectively.

Course Syllabus:

Module 1: Introduction to TGA and Regulatory Environment

  • Overview of the Therapeutic Goods Administration (TGA)
  • TGA’s role in ensuring the safety, efficacy, and quality of therapeutic goods
  • Key regulatory frameworks and guidelines

Module 2: TGA Regulations and Guidelines

  • Understanding the Therapeutic Goods Act and Regulations
  • TGA guidelines for pharmaceuticals, medical devices, and biologicals
  • Classification of therapeutic goods

Module 3: Product Registration and Submission Process

  • Preparing for product registration with the TGA
  • Submission requirements and documentation
  • Electronic submission processes (eBS system)

Module 4: Good Manufacturing Practices (GMP)

  • Introduction to GMP and its importance
  • TGA’s GMP requirements and guidelines
  • Conducting GMP audits and inspections

Module 5: Quality Assurance and Control

  • Implementing quality management systems (QMS)
  • Quality control procedures and best practices
  • Handling deviations, non-conformances, and CAPA (Corrective and Preventive Actions)

Module 6: Post-Market Surveillance and Pharmacovigilance

  • TGA requirements for post-market surveillance
  • Adverse event reporting and risk management
  • Conducting pharmacovigilance activities

Module 7: Regulatory Compliance for Medical Devices

  • Specific TGA regulations for medical devices
  • Device classification, conformity assessment, and certification
  • Labeling, advertising, and marketing requirements

Module 8: Regulatory Compliance for Biologicals

  • TGA regulations for biological products
  • Approval process and requirements for biologicals
  • Safety monitoring and reporting

Module 9: Managing TGA Audits and Inspections

  • Preparing for TGA audits and inspections
  • Conducting internal audits and mock inspections
  • Responding to audit findings and implementing corrective actions

Module 10: Practical Workshops and Case Studies

  • Hands-on training in preparing TGA submissions
  • Case studies of successful and unsuccessful TGA compliance strategies
  • Role-playing scenarios for audit and inspection preparedness

Learning Outcomes:

Upon completing this course, participants will be able to:

  • Navigate TGA regulations and guidelines with confidence.
  • Prepare and submit thorough and compliant product registrations and variations.
  • Implement and maintain GMP and quality assurance systems that meet TGA standards.
  • Manage audits, inspections, and regulatory submissions effectively.
  • Ensure ongoing compliance with TGA requirements for pharmaceuticals, medical devices, and biologicals.

Target Audience:

This course is ideal for quality assurance managers, regulatory affairs professionals, compliance officers, production managers, and other professionals involved in the pharmaceutical, medical device, and biological sectors seeking to enhance their understanding of TGA regulations and compliance.

Course Duration:

The course spans over 12 weeks, combining theoretical lessons, practical workshops, hands-on training, and real-world case studies.

Certification:

Participants will receive a Certification in TGA Compliance Training upon successful completion of the course, validating their proficiency in TGA regulations, GMP, quality assurance, and regulatory compliance.

Enrollment:

Interested candidates can enroll in the TGA Compliance Training course by visiting our website or contacting our admissions office.

Join Pertecnica Engineering and elevate your expertise in the pharmaceutical sector with our TGA Compliance Training, equipping yourself with the skills and knowledge to ensure regulatory compliance and maintain the highest standards of product safety and quality.