Compliance Trainings, Mumbai
2018-04-19
The two day workshop is designed to provide an in-depth understanding of the concept of pharmaceutical validations based on the current FDA, EU and ICH guidance documents as well as learnings from the pharmaceutical industry. Special emphasis will be laid on practical approach and simple illustrative examples from the industry for judicious and effective implementation.
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.
LEARNING OBJECTIVES FDA, ICH and EU Regulations Process Validation Validation Master Plan Equipment Qualification Risk Management Tools and Techniques Process Design and Development Technology Transfer Continuous Process Verification Analytical Method Validation Cleaning Validation SOPs and Best Practices CASE STUDIES .... and More
WHO MUST ATTEND
DEPARTMENTS:
- Quality Control - Quality Assurance - Research and Development - Manufacturing - Regulatory Compliance - Validation - Production - Technology Transfer - Laboratory - Documentation - Training departments
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