About Concept Heidelberg

Number, scope, depth and complexity of regulatory requirements in the pharmaceutical and adjacent industries are constantly increasing. Concept Heidelberg thus supports management and staff in annually more than 450 training courses and conferences across Europe in acquiring the necessary qualification to fulfil these requirements in their day-to-day work.

Courses and Conferences on Good ManufacturingPractice (GMP)

GMP courses and conferences pick up currently discussed issues, introduce latest regulatory requirements and demonstrate solution approaches. A GMP training course demonstrates the practice-oriented implementation of the regulatory requirements. At a GMP Conference or Regulatory Affairs Conference, the current regulatory developments and trends are presented by the leading experts from industry and authority. Various courses are also offered as webinars. They allow attendees to get the latest developments quickly and easily – online from their desk.

All events are planned and organised by industry and authorities experienced Concept Heidelberg project managers. All of them have been maintaining national as well as international contacts on both sides for years. Moreover, independent speakers from the industry and from authorities like FDA, EMA, PIC/S or WHO also guarantee a maximum know-how transfer. Therefore, you benefit from events planned with expert knowledge and allowing you to get first-hand information and to exchange your experience with experts.

Various institutions accept Concept Heidelberg training courses and conferences as advanced training, also showing the high quality of our events.

Please see the GMP Courses and Conferences list for all events currently offered online, on-site or as recordings.

Courses and Conferences on Good Distribution Practice (GDP)

Good Distribution Practice (GDP) is as important as Good Manufacturing Practice and has to be complied with by pharmaceutical companies, but also by logistic providers and wholesalers. In 2013, the EU Commission published a new version of the GDP Guideline. The new GDP Guideline now contains a range of requirements which have to be correspondingly implemented and documented.

Requirements regarding the storage and transport of finished medicinal products have already been existing since 1994. Yet, the revision in 2013 brought considerable tightening. Furthermore, according to Chapter 2 of the GDP Guideline on Personnel, a Responsible Person has to be appointed. Members of staff throughout the distribution chain (i.e. in warehouses, transport, and trade) as well as in pharmaceutical companies (logistics, supply chain) have to be sufficiently qualified and continuously trained.

In addition to the requirements for the transport and storage of finished medicinal products, GDP provisions must be established for the respective processes for APIs and excipients. These specifications for GDP are different from those for finished medicinal products.

Concept Heidelberg regularly organises conferences and courses on Good Distribution Practice, like for example

• Responsible Person for GDP
• GMP meets GDP
• Cold Chain Management

Please see the GDP Courses and Conferences list for all events currently offered online, on-site or as recordings.

In addition to training courses and conferences in Germany, Concept Heidelberg also plans and organises international events for various organisations – among them the ECA, the CEFIC/APIC or the European Qualified Person Association. The European API Conference has become the annual international meeting point.

On behalf of the ECA Academy, the ECA Foundation’s advanced training organisation, we organise more than 300 international training courses and conferences on-site throughout entire Europe – e.g. in Stockholm, Copenhagen, Amsterdam, Brussels, Barcelona, Madrid, Lisbon, Basel, Vienna, Milan, Budapest and Prague – online and as recordings, allowing professionals to complete the training any time. These training courses and conferences cover the most diverse needs – as the attendance from more than 20 countries annually demonstrates. In addition, Concept Heidelberg supports the ECA with comprehensive management and administrative services, like operating and maintaining the websites of the ECA Academy - considered the worldwide leading GMP and compliance knowledge platform, and of the ECA Foundation.

Concept Heidelberg also operates and maintains websites for its other international partners – mainly dedicated to larger Conferences and Congresses, but also for diverse GMP/GDP services.

Conferences

• European API Conference
• ICH Q7 Compliance Week
• European GMP and GDP Forum
• European Microbiology Conference
• QP Forum

GMP Services

• API Compliance Institute
• Pharmaceutical Consulting Alliance

Interest Groups

• European QP Association
• European GDP Association
• GMP Auditor Association
• Pharmaceutical Microbiology Group
• Validation Group
• Visual Inspection Group
• Data Integrity & IT Compliance Group
• ATMP Group
• Analytical Quality Control Group
• Austrian QP Association
• German QP Association
• Cannabis Group

For the GMP-compliant manufacture of APIs and drugs a highly qualified staff is mandatory. An academic education therefore forms the foundation, which has to be continuously supplemented by advanced training.

That's the Certification Programme's value. In addition to providing a GMP and GDP Certification Programme in German, Concept Heidelberg also offers a comprehensive international programme on behalf of the ECA. This programme allows professionals to put together courses according to their personal profile and acquire an additional qualification.

Find out more about the ECA GMP and GDP Certification Programme.

GMP/GDP training on site

On behalf of the ECA Academy we also specifically develop In-house training for you and your company. These training courses are conducted on site – taking into account your individual requirements and ideas. GMP/GDP training on site is the ideal complement to the "open GMP training".

These training courses concentrate on an overview over the comprehensive national and international regulations as well as on relevant GMP guidances in your environment. What is exactly defined? Where is interpretation allowed? What process is common and accepted? What is mandatory and what is too much?

By answering these questions we facilitate applying GMP on a day-to-day basis, promote understanding for following GMP regulations and foster a positive attitude towards GMP. Discussing current issues also makes your staff become aware of GMP regulations and solves actual problems.

The programme also takes into account site specific issues or instructions (SOPs) as well as current causes. As a result, you will receive an individual training whose form, content and level is exactly tailored to the target audience – even considering group dynamics. Ideally, a group is comprised of 20 individuals, but should definitely not exceed 30.

Our GMP/GDP in-house training differentiates Basic and Special Trainings. While Basic Training provides fundamentals, Special Training helps to advance knowledge or to gain knowledge in one specific area.

The following trainings are available:

• Pharmaceutical Production
• API Production
• Quality Control
• Pharmaceutical Development
• Pharmaceutical Technology
• Storage
• Administration
• Validation
• Computer Validation
• Inspection Preparation

Please see a list of all currently offered in-house training courses.

GMP eLearning offers the possibility to provide cost-efficiently the basics of GMP and GDP requirements to new employees and external collaborators. This is the basis for a GMP/GDP qualification.

Beside a webcast-based system which delivers GMP contents, Concept Heidelberg has extended its service portfolio on 1st October 2011 to the GMP eLearning System of MediaVision. Through this acquisition, Concept Heidelberg will be able to provide pharmaceutical and API manufacturers with GMP eLearning courses available with a company licence. More than 300 companies in 30 countries already use the system. What makes the eLearning courses unique is the availability in 12 languages.

As the programme is available online (through a media server), you only need to open the Internet browser  Internet Explorer to start a session. In a word, you can use the GMP eLearning system at each desk in your company. No need for local setup. The licences are available for a whole site without limitation regarding the number of participants.

Find out about the eLearning programme available.

Concept Heidelberg also manages the comprehensive advisory services in the field of GMP and Regulatory Compliance for the Pharmaceutical Consulting Alliance (PCA).

To find out more please visit the Pharmaceutical Consulting Alliance website.

GMP compliance audits for API manufacturers

The APIC Audit Programme is a third party audit programme to audit manufacturers of Active Pharmaceutical Ingredients (APIs).

This programme was founded by Concept Heidelberg and the APIC, a European Chemical Industry Council (CEFIC) sector group. It was established to create independent and harmonised audit reports. By forwarding these reports to pharmaceutical companies for their supplier qualification API manufacturers can reduce cost and audit frequency. The audits are conducted on the basis of the ICH Q7A (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) and with regards to the APIC Auditing Guide. Participation is voluntary and not limited to APIC members.

To implement the programme the APIC and Concept Heidelberg signed an agreement and founded the "API Compliance Institute" in December 2002.

To find out more please visit the APIC Audit Programme website.

The legislator requires an efficient training management and documentation from manufacturers of medicinal products: “The manufacturer should provide training for all the personnel whose duties take them into production areas or into control laboratories….” (EU GMP Guide).

Originally developed by Boehringer Ingelheim GmbH (today Roche Diagnostics GmbH) and today used by many international pharmaceutical companies, the software PharmSchul® supports the planning, administration, analysis and documentation of pharmaceutical trainings. Due to the possibility to follow and verify the training status for every employee prior to or during a GMP inspection the software ensures a structured training planning and assessment of demands.

Flexibility for Customisation

PharmSchul is based on a powerful and flexible data structure. The modular concept allows to customise boxes, masks and data structures without changing the PharmSchul system itself – ensuring more security for future updates that are also validated.

Take further advantage of the new user administration. Display your company’s structure and define department administrators who take care of the trainings and staff in their area. Powerful reports show potential training deficits any time.

Part 11 Compliance

In 21 CFR Part 11 the FDA defined the requirements with regard to electronic records and electronic signatures. The compliance with these requirements is the pre-condition for the use in the FDA-regulated environment. PharmSchul 5.0 also translates these requirements systematically, e.g. through:

• Installation of a client/sever architecture
• PharmSchul-Audit-Trail for documenting every change implemented
• Additional security policies in the user administration

More information – as e.g. with regard to performance features and system requirements – as well as a PharmSchul demo version is available at the PharmSchul Website.

PharmSchul® is registered trademark of Concept Heidelberg GmbH, Heidelberg.