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GMP News No. 146
15 November 2001
Professional Certification Programme
Highly qualified personnel is a crucial factor within the field of GMP-compliant manufacturing of APIs and drugs. Here, college and university education provides a scientific basis which needs to be completed. Continuous further education is therefore of considerable importance.
This is where the Professional Certification Programme of the European Compliance Academy fills the gap. The Professional Certification Programme offers modular further education with a certification at the end. Its structure takes the company's interests into account, i.e. in the further education the employee can
The European Compliance Academy offers 4 Certification Programmes. The Programmes are described in the following.
ECA Certified Quality Assurance Manager
Quality Assurance Managers are internal specialists for various compliance topics. For this task, he needs a wide-ranging knowledge. Depending on the main emphasis of his activities, he has to acquire diverse qualifications. The different seminars of this programme take this fact into account.
In order to obtain the additional certificate, the applicant must
After attending the third course the applicant obtains the additional certificate.
ECA Certified Quality Assurance Manager
The requirements to the quality assurance of active pharmaceutical ingredients have increased enormously, among others, due to the establishment of ICH Q7 A "GMP for APIs". Therefore, highly-qualified experts are necessary to put these requirements correctly into practice. The QA Manager - API production - learns the rudiments in one of the 3-day intensive courses and can deepen this know-how according to his or her focus by means of two further seminars.
In order to obtain this additional certificate, the applicant must therefore attend one of the following 3-day intensive courses:
as well as 2 courses of the following choice:
ECA Certified Quality Control Manager
In pharmaceutical quality control, the Quality Control Manager has to observe a multitude of GMP requirements. Many GMP complaints made by GMP inspectors during inspections regard the laboratory. The certification programme in hand makes it possible to qualify as specialist for GMP laboratories. It offers seminars for both microbiological and analytical quality control in order to cover both fields.
The applicants must have attended 3 of the following courses and conferences in order to obtain the certificate.
ECA Certified Pharmaceutical Engineering Manager
In pharmaceutical and API production, suitable equipment and premises are essential prerequisites for manufacture in conformity with GMP. Here, it is important to combine technical know-how with the interpretation of pharmaceutical regulations and guidelines. The Pharmaceutical Engineering Manager has the necessary skills for this task.In order to obtain this certificate, the applicant must attend a total of 3 of the following courses.
As an alternative, to obtain the certification one can attend the 4-day intensive course "Pharmaceutical Engineering" as well as 1 of the above-mentioned courses.
ECA Certified Computer Validation Manager
Computerised systems which illustrate or control quality-relevant processes are in widespread use throughout the pharmaceutical industry. Not only are they subject to the requirements of the various collections of pharmaceutical regulations for validation of these systems but since 1997 the US authority FDA lays down requirements concerning electronic records / electronic signatures in 21 CFR Part 11.In the Professional Certification Programme Computer Validation Manager participants obtain a comprehensive knowledge of the basic principles for the validation of computerised systems, the requirements of Part 11 and specific aspects of the validation of computerised systems.
Participants who have attended three courses/ conferences receive upon request in addition to the individual certificates the certificate Computer Validation Manager which identifies the participant as a qualified expert in the field of computer validation.
ECA Certified Regulatory Affairs Manager
The Regulatory Affairs Managers is an internal specialist for various regulatory affairs and regulatory rompliance topics. For this tasks, he needs a wide-ranging knowledge. Depending on the main emphasis of his activities, he has to acquire diverse qualifications. The seminars and conferences of this programme take this into account.
In order to obtain the additional certificate, the applicant must attend 3 courses / conferences of the following choice:
Expansion of the Programme
During the next months further courses will be included into the Certification Programme. This will enable the participant to select his or her individual topics for a certificate even more flexibly.
The Professional Certification Programme represents a useful completion of college and university education. The courses of the European Compliance Academy enjoy an excellent reputation within Europe's pharmaceutical industry. This is proved by the large numbers of participants, the often booked-up courses and the fact that many speakers and participants come from European supervisory authorities.
What is essential for the recognition of qualified further education is the speakers' reputation. You can often observe that education courses are lead by one or two consultants. ECA itself employs up to 8 speakers for an education course. By preference, representatives from industry and authorities are invited. Consultants with a good reputation complete a qualified further education.
Recognition of Past Events
If you visited in the past one or more seminars that are today part of the Professional Certification Programme, these seminars will of course be recognised.
How to Obtain the Certificate
To obtain the certificate, the participants send a copy of each of the corresponding certificates of participation to:
The certificate will be issued within the following 2 weeks.