As long as increase in the regulatory requirements and market needs which causes conflicts between inspectional parties and manufacturers along with limited resources for each party, there must be a harmonized baseline between two parties that both must agree on. Upon achieving this harmonization, this will minimize the efforts that will in turn increase the quality of the product.
Risk-Bases Q&V is considered main pillar to conduct the Q&V plan mainly for the systems that could impact the product Quality (SISPQ) , and this will definitely increase the compliance awareness and decrease the cost as well.
This course is about the technical, compliance and business benefits when conducting the Qualification and Validation (Q&V) for different systems within Pharmaceutical manufacturing facilities, and will also discuss the best Q&V Risk-based approach to minimize the efforts to have your system qualified and validated
Areas Covered in the Session:
Who Will Benefit:
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