EXPANDED CONTENT NOW ACCORDING TO NEWLY PUBLISHED EU, PIC/S GMP ANNEX 1, AND FDA COMPUTER SOFTWARE ASSURANCE GUIDELINES.

OUR PARTICIPANTS WILL BE ENTITLED TO RECEIVE DOUBLE LEAD AUDITOR CERTIFICATES.

The first 3 DAYS ONLINE and the second 3 DAYS F2F training have been prepared for professional people who will be actively involved in 1st, 2nd, and 3rd party audits. The aim of the training is to train the lead auditor to manage the audits to be carried out according to international and local GMP guidelines and directives. The training was created on the basis of all quality management systems implemented in the pharmaceutical, biotechnology, and medical device sectors. The duties and responsibilities of the lead auditor and the planning, announcement, realization, reporting, and follow-up audits of the audit are supported by role play, case studies, and scenario studies.

Unfortunately, we have to face the fact that we have to perform the audits because there is a GMP—Good Manufacturing Practices—requirement. Actually our real problem is that we believe that the more we audit, the more we will comply with regulations and laws. However, GMP is talking about the reality that audits are carried out to ensure that all our operations are guaranteed.

Are you outsourcing your manufacturing and/or analysis operations?
Are you packing your products after bringing them from abroad in bulk?
* Do you have a contracted service provider agreement with other pharmaceutical companies?
* Do you want to increase the number of countries you export to in your portfolio?
* Do you want to control and qualify the Pharmaceutical Active Ingredient (API), Excipient, and Primary & Secondary Packaging Materials Manufacturers and/orSuppliers, which are the most important components for pharmaceutical production?
* Do you want to develop your business in other areas?
* Do you want to prepare for MHRA, FDA, PIC/S, or any other authority audits and avoid any findings?
* Are you a health authority auditor who is willing to improve his auditing skill?

We do know that the majority of your answers are “Yes.” The ability to fulfill all these responsibilities completely and successfully is directly related to your performance in all the audits you experience. A good audit can take place with your GMP lead auditors who have mastered GMP and pharmaceutical quality management systems. The GMP inspection mechanism is the most important criterion in performance measurements, and it is a golden value opportunity for the continuous development of your Pharmaceutical Quality Management System. Thanks to GMP, you prioritize the efficiency, quality, and safety of the products you manufacture. However, in today’s competitive market, pharmaceutical companies are paying more attention to business success, customer-oriented approaches, and improved process performances. The most critical point in the success of pharmaceutical quality management systems is GMP audits, and you are the GMP lead auditors who carry out these audits. While a successful lead auditor performs GMP-compliant audits, he must also be able to uncover areas with development opportunities, taking into account all processes of his organization.

The format of this training is to educate and train GMP Lead Auditors who can discover opportunities where there may be real performance gains while performing GMP audits. Having auditors with both features in today’s business world will fill a very important gap in order for your organization to compete without lagging behind the market. Pharmaceutical companies employing certified GMP lead auditors are your most key employees to fully prepare for both GMP internal audits and customer audits as well as supplier and health authority audits. With this training, you will learn how to achieve real added value and how to improve the performance of your processes, as well as how to conduct GMP-compliant audits by observing some indispensable criteria.

After the lectures, your GMP knowledge will rise to the highest level with scenarios and case studies. In addition to the training presentation, BONUS documents containing approximately hundreds of questions, including GMP & GDP and Data Integrity Audit Question Lists, will also be presented. The six (6) day Certified Pharmaceutical Quality Management System & GMP Lead Auditor training organized by QUALITY ACADEMIA was designed and developed by experts who worked as managers and lead auditors in the pharmaceutical industry. Our course has content enriched with interactive applications, scenario work, and role plays.