Basics of GMP: Ensuring Quality in Pharmaceutical Manufacturing

The Basics of GMP course offers participants a solid foundation in the principles and requirements of Good Manufacturing Practice (GMP) within the pharmaceutical industry. GMP is a critical component in ensuring pharmaceutical products' quality, safety, and efficacy. This course covers the key elements of GMP regulations and guidelines, equipping participants with the knowledge and skills needed to maintain compliance and uphold the highest standards in pharmaceutical manufacturing.

Target group

This introduction level course is ideal for professionals involved in the pharmaceutical manufacturing process, including:

• Quality Assurance (QA) and Quality Control (QC) personnel
• Production and manufacturing staff
• Regulatory affairs specialists
• Research and development scientists
• Supply chain and logistics managers
• Compliance officers
• Anyone new to the pharmaceutical industry or seeking a refresher on GMP principles

Why participate?

By the end of this training, participants will:

• Understand the fundamental principles and objectives of GMP.
• Recognize the importance of GMP in ensuring product quality and patient safety.
• Learn how to apply GMP throughout various stages of pharmaceutical manufacturing.
• Earn a certificate of completion after passing a short knowledge test.
  
  

Course content 

This self-paced, online course can be completed at your convenience. The training contains self-study material, and after passing the final test, you'll receive a certificate. The estimated course duration is approximately 2 hours.

Topics:

• What is GMP?
• Pharmaceutical quality system
• Personnel
• Premise and equipment
• Documentation
• Production
• Quality control
• Outsourced activities
• Complaints and product recalls
• Self Inspections
• Risk assessment 
• Other parts of GMP

Trainer

The trainer is Soile Hakala from Medimo Oy. Soile has almost 20 years of experience in quality assurance within the pharmaceutical industry. The quality tasks in manufacturing sterile products, raw materials and packaging materials are familiar to her. Soile also has experience in GMP/GDP training. Soile has audited several manufacturers (raw materials, packaging materials, distributors, contract laboratories and contract manufacturers). She has been involved in manufacturing transfer projects as a quality representative. She has also acted as the contract manufacturer's Qualified Person (QP).

Soile has experience in setting up a quality system in the pharmaceutical industry and ensuring that all quality documentation meets GMP (Good Manufacturing Practice) and ISO 13485 requirements. Soile has been the responsible person (accountable director) of the pharmaceutical manufacturer and wholesale company.

Price and registration

The price of the online course is 295 € (+ VAT). 

After registering, you will receive a confirmation email with instructions on how to log in to the online learning environment. You can log in to the online learning environment using your personal credentials. You have 31 days from registration to complete the training.

Request an offer for unlimited organization access or a larger group here.

Please read the change and cancellation terms before registering under: Instructions for participants. Pharmaca reserves the right to modify training details.

You can easily pay for this training using a credit card, online payment, or mobile payment, as well as by invoice. The invoice will be generated automatically based on the information you provide and will be sent 1 to 4 weeks before the training date/after registration. Please also include any possible PO number when you register.