Planning GMP audits with a disciplined and meticulous approach offers numerous benefits for both the GMP auditor conducting the audit and the audited party. While GMP audits are an authority obligation, they also provide added value during internal audits. Additionally, external audits give the audited party the opportunity to discover facts they may not have been aware of.
A GMP auditor must be prepared to handle unexpected situations at any stage of the audit and must complete the qualification process by undergoing the necessary training in this field. While GMP auditors do not evaluate audits solely based on findings, the prejudices, unrest, lack of cooperation, and contrary behavioural patterns of the audited party may lead the auditor to evaluate the audit from a different perspective.
In difficult situations, the auditor should remain polite but firm, maintaining self-control and full command of the audit. This training aims to provide insight from the GMP auditor's perspective, help the audited party cope with challenging situations, and offer strategies for overcoming them.
Benefits of attending
- Learn effective communication strategies to maintain a positive relationship with auditors, even during tense or difficult moments
- Gain tools for resolving conflicts in a calm and professional manner, helping to avoid misunderstandings or escalations during GMP audits
- Learn how to identify potential compliance risks and address them proactively during an audit, minimising the chance of significant issues
- Improve your ability to build trust and rapport with auditors, leading to better working relationships and smoother audit outcomes
- Discuss the legal and regulatory frameworks surrounding GMP audits, so you’re better prepared to respond effectively and stay compliant
- Consider strategies for turning challenging situations into opportunities for improvement, leading to positive audit results and a more robust quality system
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
Course Content
Course Provider
Mustafa Edik,
Independent GMP Consultant and AuditorAfter graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry.
He has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies.
While he was the Vice President of Quality and Technical Operations at a Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines.
He finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University - Ireland. He is the author of chapter 6 of the book published by PDA named “Good Distribution Practices” and he is preparing his latest book on ‘GMP Audits’ which will be published by Taylor & Francis in 2023.
Who Should Attend
This training would suit those in the following professional roles:
- Quality Assurance
- Quality Control
- GMP Compliance
- GMP Auditors
- Auditing
- IT
- Regulatory Affairs
- Engineering
- Supply Chain
