The best strategy to minimize risks in drug manufacturing operations is to validate every process you use. This includes manufacturing processes, analytical methods, IT systems, and cleaning procedures. Validation enables you to optimize production operations, improve the safety and quality of your products and consequently increase your customers’ confidence. Don’t leave luck to chance, invest in process validation and ensure the success of your business with RC REDOL’s Pharmaceutical Validation training. Read how below.
According to current Good Manufacturing Practices, validation in the pharmaceutical industry can be defined as “Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specifications and quality attributes”.
Within this scope, a significant aspect of Validation is establishing well-defined protocols, which help Validation standardize information and record everything that occurs. In practice, Pharmaceutical Validation needs a solid Quality System, which works well at all times, and a vital part of that process depends on well-trained people. Only then can you guarantee the prized Quality.
This is where RC REDOL training courses can help you! We offer specialized training in GMP compliant Validation, which covers diverse but essential topics such as:
Process Validation
o General principles and practices
o What is the applicability
o There has to be a plan and “how to do it”.
o What are the Good Practices for a successful validation
o Process qualification
o Continuous verification
o Batch release
Analytical Validation
o Before validation
o Overview of the validation process
o Validation characteristics by method type
o Validation characteristics
o Method comparison
o After validation
Cleaning validation
o What is the plan
o Choose the worst-case product
o Cleaning procedure
o Acceptance Criteria
o Cleaning Procedure Validation
o Change Control and Revalidation
Cleaning Retention Time
o Definition of the validation process
o Definition of the Retention Time
o Retention time – critical points
o Importance of respecting the retention time
o Downtime
The Validation Training was developed to meet the specific needs of your company and adapted to analysts, operators, and supervisors. Opting for a format of classes in groups of up to ten people, learning is maximized through practical examples, allowing your company’s human resources to achieve maximum efficiency quickly and in a well-founded manner.
If you are looking for customized solutions and training in Good Manufacturing Practices taught by experienced experts with more than 20 years of experience in Pharmaceutical Quality, RC REDOL is the right choice for you. How? We guarantee efficiency, always adapted to the profitability of your business, and improve the performance of your quality system by keeping your company up to date with the latest regulations. Contact us to learn more about our GMP Validation Training and find out how to ensure one of the most vital processes for the success of your business.
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