Sale Date Ended
The two day workshop on GMP for Quality Control Laboratories and FDA Audit Preparation, is designed to provide an in-depth understanding of the regulatory background and guides attendees through all critical areas of GMP compliance. You will gather a thorough awareness of latest trends and updates with respect to USFDA, EU, WHO and PIC/S (Pharmaceutical Inspection Co-operation Scheme) and Indian GLP Schedule L1 compliance and guideline requirements. This course will also provide examples to develop inspection ready documentation.
The participants will be exposed to the latest concepts and thinking of international regulatory agencies on validation of manufacturing process, analytical as well as cleaning methods applicable in API & Oral Solid Dosage forms manufacturing based on assessed risk. The workshop will also include typical examples from the industry and the participants will be able to execute validations in a judicious manner.
On completion of this course, the participants shall be well versed with the global Quality control laboratory compliance requirements, inspection trends as well as strategies and best practices for maintaining regulatory compliant GLP standards to ensure consistent Quality Attributes and bench marking Quality Metrics in the Pharmaceutical Quality Control Laboratories.
Practical examples and interactive exercises will be dispersed into and between the presentations. Here the experts will discuss case studies and create a platform platform to resolve QC laboratories' day-to-day issues like Documentations, Investigations (OOS, OOT, OOC) and validation compliance checklists to ensure you are well prepared for your next audit.
LEARNING OBJECTIVES :
FDA, EU, WHO, PIC/S, India GLP Regulations
21 CFR part 11 and EU Annex 11
FDA 483s and Warning Letters Observations
Validation Master Plan
SOPs and Best Practices
Equipment Calibration and Qualification
Systems Validation
Analytical Method Validation
OOS, OOT and OOC
Laboratory Data integrity
FDA Audit Preparation
CASE STUDIES .... and
WHO MUST ATTEND
DEPARTMENTS:
- Quality Control
- Quality Assurance
- Research and Development
- Manufacturing
- Regulatory Compliance
- Validation
- Production
- Technology Transfer
- Laboratory
- Documentation
- Training departments
PROFESSIONALS:
- Managers
- Supervisors
- Senior Managers
- Team Leaders
- Executives and Senior Executives
- General Managers
- Engineers
- Design Engineers
- Plant Managers
- Laboratory Managers and Supervisors
- Regulatory Affairs Managers
- Documentation Specialists & Analysts
You can pay via CHECK or Wire Transfer. For more details please contact support team.
