Current GOOD MANUFACTURING PRACTICES FOR
HOSPITALS AND FOR BIO-PHARMACEUTICAL
PRODUCTS
Tentative Program, May 19-21, 2010
Course Description
In the past decade regulations for the manufacture of therapeutic and diagnostic
reagents for clinical use in vivo have become more strict. In recent years there is
now also a focus on the use of pharmaceuticals, pharmacists and other medical
staff in hospitals. Quality Assurance and Control throughout the development
at all production stages as well as during clinical trials and administration to
patients is necessary, in addition to the testing of end products.
In the Life Science industry as well as in the Biopharmaceutical industry this
all needs to be in line with and according to the guidelines from the regulatory
authorities such as the FDA. Common concepts today like cGMP, GAMP,
21CFRpart11 and other guidelines are ruling the life of the bioprocess scientists.
This involves the production utility unit, equipment (fermentor/bioreactor), the
process control system as well as for development in R&D, process development
and production. Also optimal training of personnel working in pharmaceutical
production areas or in hospitals is essential to achieve safe treatment of patients
with high quality products.
The emergence of new products from biopharmaceutical industries, such as genetherapy,
stem cell therapy, vaccines and monoclonal antibodies, have added a
dimension to Requirements for the Registration and bio-safety testing. It is also
essential to be fully aware of these issues when products are still at the research
stage, to achieve cost-effective product development and high quality products
and to avoid delay at later stages.
This 3 day cGMP training course for manufacturers and for staff working in
hospitals will give you an introduction and overview of current EU as well as
USA-FDA regulatory requirements and GMP for biotechnological products and
production processes as well as for medical devices and/or will update your
present knowledge in this rapidly developing field. Furthermore a workshop will
be held dealing with case studies and GMP problems and solutions. In addition
during this course you will visit and be guided through some new (GMP) facilities
for the manufacture of (bio) pharmaceuticals such as monoclonal antibodies.
Who Should Attend
This course is designed for personnel involved in the development, production,
validation, control and registration of pharmaceutical products derived from biotechnological
processes within the (bio)pharmaceutical and related health care
industries as well as decision makers such as:
- Production managers and supervisors
- QA and QC personnel involved in self-inspections
- Personnel involved in Regulatory Affairs
- Clinical trial supply personnel and hospital staff members
- Pharmacists
- Personnel involved in the registration requirements and the
set up of the registration dossier
- Researchers in the development of
bio(techno)logical products for clinical use
- Executives responsible for these sections
Course Director
Rene J. van de Griend Ph.D. Qualified in cell biology and medical immunology.
In 1976 he started his research career at the Central Laboratory of the Red Cross
Blood Transfusion Service in Amsterdam. He gained a Ph.D. in 1981 from the
faculty of medicine, University of Amsterdam. Thereafter he was employed as
Immunologist at the Dr.Daniel den Hoed Cancer Center in Rotterdam for the
development and implementation of immunotherapy protocols. He is an experienced
scientist in cell biology and immunology and has published over 75
scientific papers. In 1987 he joined Centocor Europe in Leiden, The Netherlands
to manage and starting up R&D fermentation projects for production of Mab’s
at pilot and industrial scale. At present, as managing director of BIOCULT bv
(www.biocult.com), he is involved in up-scaling (contract production) of cell
derived proteins, especially monoclonal antibodies in Leiden, The Netherlands.
BIOCULT is NEN-EN-ISO-9001:2008 certified and in addition
Tel: 31-71-5215443
e-mail: Biocult@sandtcourses.nl www.SandTcourses.nl
Wednesday, May 19-21, 2010
9.00 |
Introduction into GMP regulations, personnel training, gowning and
Quality Control strategies for pharmaceutical production facilities.
Dr.Ir.J.L.M.van der Lubbe (10)
|
10.30 |
Sterilisation of equipment, sterility and (environmental) monitoring.
Dr.Ir.J.L.M.van der Lubbe and Ing.Ronald Slob (10) |
12.00 |
Cellbank development and maintenance for production
Dr.R.J.van de Griend (1)
|
| 12.30 |
cGMP in Manufacturing (API’s) by cell culture
Drs.R.Eimers (11)
|
|
lunch
|
14.30 |
Cell-and immunotherapy: from bench to bedside within an academic
setting
Dr.J.Oostendorp (13)
|
15.30 |
Strategy in Protein purifi cation and process examples
Dr.Lothar Jacobs (12) |
16.30 |
Excursion to LUMC-GMP facilities: guided tour and video
M.Zandvliet/J.Oostendorp (13) |
|
dinner |
Thursday, May 20
8.45 |
Personnel training requirements for GMP
Dr. G. Fransen (15) |
9.30 |
General Documentation Practices in GMP
Dr.G.Fransen (15) |
11.00 |
Auditing Sterile Manufacturing
Dr.G.Fransen (15)
|
12.00 |
GMP practices in a GCP environment
Dr.G.Fransen (15)
|
|
lunch |
14.00 |
Regulatory affairs and registration dossiers EU versus USA
Ineke Jonker MSc. (10) |
15.00 |
Audits and (self)Inspections
Mieke van der Meulen MSc. (10)
|
16.15 |
Current GMP for hospitals and (hospital)pharmacies
Simone Meulenbelt MSc(10) |
17.30 |
Bioreactor design for animal cell cultures: cGMP aspects, Bio-process
control, SCADA and 21CRFpart11 (GAMP aspects)
E.Kakes (14) |
|
dinner |
Friday, May 21
|
|
Validation: principles, documentation and qualifi cations for
pharmaceutical production
Dr.Ir.J.L.M.van der Lubbe (10) |
10.45 |
Computer validation and risk assessment
Colin J.Goddard (16)
|
12.00 |
Regulations, guidelines and current industry problems
Colin J.Goddard (16) |
|
lunch |
14.00 |
workshop
|
15.00 |
Validation of processes, cleaning and analytical methods
Dr.Ir.J.L.M.van der Lubbe (10)
|
16.00 |
Results and evaluation from workshops and group
discussion on various topics introduced by the
course participants
Dr.Ir.J.L.M.van der Lubbe (10) |
17.00 |
End of course program and departure |