Mustafa Edik

This training course prepares professionals in pharmaceuticals, healthcare, and manufacturing to navigate regulatory inspections by major health authorities including the FDA, MHRA, WHO, and EMA.

This training programme provides essential skills for planning, managing, and executing internal Good Manufacturing Practices (GMP) audits.

This training provides knowledge and practical skills to effectively audit material and service providers, covering key areas including raw materials, contract manufacturing, logistics, and packaging.

Maintaining a sterile production environment on an ongoing basis is critical in the production of sterile pharmaceuticals, and strict adherence to guidelines and relevant standards is required to minimize contamination risks and ensure product quality and safety. During this training, all changes in Annex 1 will be evaluated, and the minimum requirements that aseptic operations must meet will be discussed and presented to the participants through examples.

This training equips auditors with strategies to handle obstacles such as documentation errors, unethical behaviours, resistance, and time-wasting tactics, ensuring a smooth and productive audit process.

Master the principles of cleaning validation to ensure pharmaceutical manufacturing equipment meets stringent regulatory standards, preventing contamination and safeguarding public health.

Gain a comprehensive understanding of industry-leading practices, ensuring precision in distribution from manufacturer to end user. Navigate complex supply chains, focus on compliance, and elevate your commitment to quality assurance throughout the entire distribution process.

One of the most valuable tools for auditors in the pharmaceutical industry is the ability to conduct thorough and effective interviews during audits. This training will equip you with these essential skills.

This training will equip attendees with the practical skills necessary to implement regulatory-compliant distribution and storage systems, ensuring both pharmaceutical integrity and patient safety.

Explore the intricacies of Life Science Supplier Qualification through our comprehensive course. Gain expert insights into regulatory compliance, supply chain optimization, and strategic sourcing. Elevate your proficiency in maintaining product integrity with proven industry best practices.

Vaccinology continues to advance and mature impressively, both in developing new and improved vaccines and in administering vaccines to prevent disease. On this course, explore GMP principles in vaccine manufacturing.

In this talk, explore the fundamental concepts, techniques, and processes that make up the backbone of biomanufacturing, pharmaceutical production, and biotechnology.

In this two-day course, you will be able to gain a whole new perspective on GMP requirements, including how to implement them.

Learn to conduct thorough audits, identify non-conformities, and recommend corrective actions while following the Golden Rules of successful GMP auditing.

During this course, data integrity will be discussed from the perspective of GxP audits, with practical advice for successful data integrity audits given.

This course focuses on the Regulatory and Quality Management System links to Process Validation for medical devices, and reviews the Installation Qualification, Operation Qualification and Performance Qualification Processes and how these fit with regulatory needs and technical documentation.