Dublin, Oct. 25, 2023 (GLOBE NEWSWIRE) -- The recent Financial Times revelation that the pharmaceutical industry is nearing an accord with the UK government over drug pricing has rippled through the industry, illuminating the imperatives of compliance and optimal batch record review. In sync with this evolving landscape, ResearchAndMarkets.com has added the "4-Hour Virtual Seminar on Batch Record Review and Product Release" webinar to its portfolio - a pivotal resource for industry stakeholders.
This seminar stands out as an indispensable tool at a juncture when the pharmaceutical landscape is witnessing seismic shifts. The earlier voluntary scheme's impact on the NHS drugs bill, which witnessed a surge in the clawback tax from roughly 5% to a staggering 26.5%, underscores the urgent need for impeccable documentation and compliance standards. Against this backdrop, our product is particularly tailored for business entrepreneurs and managers striving for heightened precision in batch record documentation.
Navigating the intricate maze of pharmaceuticals, biologics, and medical devices requires a foundational understanding of the Regulatory Agencies' stringent mandates. A paramount component in this sphere is the batch record - a meticulously crafted written procedure that charts the entire trajectory of the production and manufacturing process.
This seminar will equip attendees with:
- Deep insights into the significance of the Batch Record process, ensuring every production facet meets rigorous regulatory benchmarks.
- Skills to recognise the regulatory mandates for batch records and their reviews.
- Techniques for fostering productive collaborations between production and quality reviewers.
- Strategies for addressing batches that fail to meet prescribed specifications.
Agenda
- Lecture 1: A thorough overview of Regulatory Requirements for GMP Documents, encapsulating Batch Records and other key documents.
- Lecture 2: Delve into effective methodologies for Batch Record Review.
- Lecture 3: Uncover techniques for Data Review and managing Deviations.
- Lecture 4: Engage in a case study that elucidates the review of a mock Batch Production Record.
The seminar's credibility is bolstered by the acclaimed speaker, Danielle DeLucy, MS. A stalwart in the pharmaceutical domain, Danielle owns ASA Training and Consulting, LLC. Her illustrious 15-year journey encompasses myriad Quality Management roles, from directing Product Quality to overseeing Sterility Assurance practices. With a legacy of leading numerous Regulatory Health Inspections, Danielle's prowess in Quality Control is unmatched. Her current endeavour is to assist companies grappling with warning letters, consent decrees, and the quest for enhanced compliance.
The landscape of pharmaceutical regulations and compliance is perpetually evolving. For business entrepreneurs and managers, staying updated is not a mere advantage but a necessity. The "4-Hour Virtual Seminar on Batch Record Review and Product Release" serves as an essential compass in this journey, ensuring you remain at the forefront of regulatory compliance and industry best practices. Don't miss this opportunity to elevate your proficiency and remain a step ahead in the dynamic world of pharmaceuticals.
For more information about this seminar visit https://www.researchandmarkets.com/r/xzainn
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