Search for GMP/GDP Training Courses and Conferences

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

The training content depends on your individual needs and ideas. A course can take into account the specific situation in your company and considers the latest GMP publications. Both the training course's content and structure are tailored to the target group - also considering group-dynamic effects.

Do you need an individual training offer? Please send us an e-mail.

Topics for in-house training courses including exemplary agendas:

Subject of the Training Course

APIs

Basic Course GMP for APIs (ICH Q7 Compliance)

Basics

Basic GMP Course: Regulatory and GMP Requirements for Pharmaceutical Companies Basics - GMP Training Qualification/Validation Basics - GDP and FMD Course Basics - Good Clinical Practice Basics - GMP for APIs (ICH Q7 Compliance)

Good Clinical Practice

Basic Course in Good Clinical Practice GMP/GCP Training: Investigational Medicinal Products (IMPs)

Good Distribution Practice

Good Storage Practice Good Distribution Practice (Storage, Transportation, Cold Chain) Basic GDP and FMD Course - An Introduction to Good Distribution Practice and Falsified Medicines Directive

IT/Computer Validation

Regulatory Compliance for IT Professionals Electronic Records and Electronic Signatures (21 CFR Part 11) Validating Computerised Analytical Equipment and Systems CSV – EU GMP Annex 11

Medical Devices

Regulatory Requirements on Medical Devices

Quality Assurance

Data Integrity – General Training Auditing / Self-Inspection Deviation, Failure Investigation, Annual Product Review and Change Management Medicinal Products and Medical Devices - How to act on Combination Products Change Management – Changes and Deviations GMP and FDA Compliance in Quality Assurance Units Pharmaceutical Quality Systems Hygiene Training Course Training for Auditors Training for Investigators

Quality Control

Stability Testing in the Pharmaceutical Industry Out-of-Specifications and Out-of-Trend results Statistical Tools for QC and R&D Laboratories Understanding Design of Experiments (DOE) GMP Requirements to Quality Control Laboratories Reduced Testing and Reduced Sampling in Analytical Laboratories (1 day or 2 days) Fundamentals of Statistics for Quality Control and Quality Assurance (2 days) Advanced Statistics for Quality Control and Quality Assurance (2 days) Validation of Analytical Procedures in Pharmaceutical Analysis and Quality Control (2 days) Lifecycle Management in Pharmaceutical Analysis (2 days)

Regulatory Affairs

Regulatory Structure and Content of the Regulations - Regulatory Requirements for Pharmaceutical Companies Quality Data in the Marketing Authorization Application Marketing Authorizations and Life Cycle Management Steps from Drug Development to Marketing Authorization The Regulatory Aspects of Validation and Implementation of a New Technology

Sterile Manufacturing / Aseptic Processing

Sterilization Validation in Aseptic Pharmaceutical Production GMP for Beginners in Sterile Manufacturing GMP Training Microbiological Environmental Monitoring (1 day) GMP Training "Sterilization validation in aseptic pharmaceutical production" (2 days) GMP Training "Sterilization validation in aseptic pharmaceutical production - compact" (1 day) GMP special training "Steam sterilization in aseptic pharmaceutical production - compact" (1 day) GMP Training "Steam sterilization in aseptic pharmaceutical production - incl. sterilization validation" (2 days) GMP Training "Sanitization and Decontamination of Equipment and Critical Areas" (1 day) GMP Training "(Bio)Decontamination of Cleanroom, RABS and Isolator" (1 day) GMP Training "Aseptic Process Simulation with Media Fills" (1 day) GMP Training "Dry heat sterilization & depyrogenation in aseptic pharmaceutical production - compact" (1 day) Parenteral Packaging Development

Technical Operations

GMPs for Equipment, Utilities and Facilities Pharmaceutical Water GMP-compliant Maintenance & Calibration

Validation/Qualification

Qualification and Validation in Pharmaceutical Production GMP Training "Cleaning validation in pharmaceutical production - compact" (1 day) Basic GMP Training Qualification/Validation GMP Training "Cleaning Validation in Pharmaceutical Production" (2 days) Evaluating and Trending of Process Data for Continued Process Verification and for Annual Product Quality Review (APR/PQR) Understanding Design of Experiments (DOE)