ECA - European Compliance Academy - Inhouse Training Programme

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In-house Training

GMP In-house Training Programme
for the Pharmaceutical, API and Medical Device Industry

Subject of the Training Course	Number of Days	Number of Speakers
Basic GMP
Basic GMP Course Regulatory and GMP Requirements for Pharmaceutical Companies (e-mail inquiry)	1	1
Basic GMP Training for Employees of Dosage Form Development (e-mail inquiry)	1	1
Quality Control
FDA Compliance in Quality Control (e-mail inquiry)	2	1
Stability Testing in the Pharmaceutical Industry (e-mail inquiry)	2	2
Out-of-Specification Results (e-mail inquiry)	2	1
Quality Assurance
Deviation, Failure Investigation, Annual Product Review and Change Management (e-mail inquiry)	1	1
Auditing / Self-Inspection (e-mail inquiry)	1	1
Quality Assurance Systems Based on ISO 9001 and GMP (e-mail inquiry)	1	1
Change Management - Changes and Deviations (e-mail inquiry)	1	1
Good Storage Practice (e-mail inquiry)	1	1
GMP and FDA Compliance in Quality Assurance Units (e-mail inquiry)	2	2
Pharmaceutical Quality Systems (e-mail inquiry)	2	1
Hygiene Training Course (e-mail inquiry)	2	1
IT/Computer Validation
Regulatory Compliance for IT Professionals (e-mail inquiry)	1	1
Validating Computerised Analytical Equipment and Systems (e-mail inquiry)	2	1
Electronic Records and Electronic Signatures (21 CFR Part 11) (e-mail inquiry)	1	2
New EU GMP Annex 11 Regulations for Computerised Systems (e-mail inquiry)	2	1
Validation/Qualification
Qualification and Validation of Equipment and Processes in Laboratories and Manufacturing (e-mail inquiry)	2	1
Basic GMP Training Qualification/Validation (e-mail inquiry)	1	1
Cleaning Validation in Pharmaceutical Drug Product and API Production (e-mail inquiry)	2	1
Sterile Manufacture
Production of Sterile Pharmaceuticals (e-mail inquiry)	2	1
Good Clinical Practice
Basic Course in Good Clinical Practice (e-mail inquiry)	1/2	2
Medical Devices
Regulatory Requirements on Medical Devices (e-mail inquiry)	1	1
APIs
ICH Q7A Compliance (e-mail inquiry)	2	1
Regulatory Affairs
Regulatory Structure Regulatory Requirements for Pharmaceutical Companies (e-mail inquiry)	1	1
The Regulatory Aspects of Validation and Implementation of a New Technology (e-mail inquiry)	1	1
Steps from Drug Development to Marketing Authorisation (e-mail inquiry)	1	1
Marketing Authorisations and Post-Approval Obligations in the EU (e-mail inquiry)	2	1
Quality Data in the Marketing Authorisation Application (e-mail inquiry)	1	1