Professional Certification Programme

GMP News No. 146

GMP News
15 November 2001
   

 Professional Certification Programme 

 
The European Compliance Academy offers from now on a new qualification programme. The programme makes it possible to combine several seminars in such a way that an additional certificate can be acquired.

Objective

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

  • select courses according to his or her individual professional demands
  • suit the course registration to the company's necessities, i.e. usually there is a time span of several months between the courses. Should the situation arise that two dates are too close together, one course can be attended in the following year.
  • By taking part in an education course the applicant becomes an ECA member, which means that, apart from the CD-ROM (GMP Navigator), he is given a discount of 10% on future courses during the following two years. With every further course he attends, the time span for the discount is prolonged by 2 years.
  • Certification Opportunities

    The European Compliance Academy offers 4 Certification Programmes. The Programmes are described in the following.

    ECA Certified Quality Assurance Manager
    - Pharmaceutical Production -

    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 attend
    3 courses of the following choice.

    • GMP/FDA Compliance in Quality Assurance Units
    • Out of Specification Results/ Failure Investigation
    • GMP Compliance for Batch Documentation
    • GMP Compliance Auditor
    • Validation Manager
    • EU-GMP and FDA Compliance in Pharmaceutical Development
    • Microbiology for Non-Microbiologists
    • FDA/GMP Requirements on Environmental Monitoring

    After attending the third course the applicant obtains the additional certificate.

    ECA Certified Quality Assurance Manager
    - API Production -

    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:

    • ICH Q7A Compliance for APIs Manufactured by Chemical Synthesis or
    • ICH Q7A Compliance for APIs manufactured by Cell Culture / Fermentation

    as well as 2 courses of the following choice:

    • GMP/FDA Compliance in Quality Assurance Units
    • Out of Specification Results / Failure Investigation
    • GMP Compliance for Batch Documentation
    • GMP Compliance Auditor
    • Validation Manager
    • Microbiology for Non-Microbiologists
    • ICH Q7A Certified Auditor

    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.

    • FDA Compliance in Analytical Laboratories
    • Validation of Microbiological Test Procedures
    • Validation of Analytical Test Procedures
    • Reference Standards
    • Stability Testing
    • GMP/FDA Compliance in Quality Assurance Units
    • Out of Specification Results
    • EU-GMP and FDA Compliance in Pharmaceutical Development
    • FDA/GMP Requirements on Environmental Monitoring
    • Masterclass "Micorbiological Challenges for GMP/FDA Compliance"
    • Successful HPLC Management in a GMP/FDA Regulated Environment

    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.

    • Calibration / Measuring Technology in the Pharmaceutical Industry OR
    • Measuring Technology for the Pharamceutical Production
    • FDA and EU GMP Compliance for Cleanrooms
    • FDA- and GMP-Compliant Design of Equipment
    • FDA-/GMP-Compliant Water Systems

    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.

    • GMP Compliance for Computer Validation
    • User Requirement Specifications on Computer Validation
    • Risk Assessment and Change Control in Computer Validation
    • 21 CFR Part 11 Compliance. FDA Requirements and Implementation of Electronic Records / Electronic Signatures
    • How to Qualify IT Networks
    • FDA/GMP Requirements on IT Infrastructure
    • Validating Computerised Analytical Equipment and Systems
    • Writing User Requirement Specifications to Meet FDA Guidelines
    • Exploiting the Benefits of Electronic Signatures
    • SAP R/3 Validation and Part 11 Implementation

    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:

    • CEFIC/APIC European Conference on APIs - Regulatory Affairs Part
    • CTD, CEP and DMF - Quality of Drug Substance
    • Validation of Microbiological Test Procedures
    • Validation of Analytical Test Procedures
    • Reference Standards
    • Stability Testing

    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.

    Recognition

    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:

    ECA
    P.O. Box 10 21 68
    D-69011 Heidelberg

    The certificate will be issued within the following 2 weeks.
    In addition it is necessary to send a confirmation issued by the company that the applicant has been working for a minimum of 2 years in the pharmaceutical industry. Applicants who want to obtain the Pharmaceutical Engineering Manager Certificate may also send a confirmation from a supplier company.

     

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