Keep Up with Pharmaceutical Manufacturing Best Practices & Navigate Compliance Standards
ISPE sat down with Carmelo Rosa, PsyD, Director, Division of Drug Quality and Senior Officer of Compliance, FDA/CDER, and co-chair of the 2019 ISPE South Asia Pharmaceutical Manufacturing Conference to discuss key event highlights and takeaways
The conference will be held in Bangalore, India, on 26-27 September. In conjunction with the event, ISPE will also host an Executive Forum: Assuring Due Diligence in Acquiring New Facilities on 25 September (Separate Registration Required). Primarily for senior executives and mid-level managers, this intimate event will provide a realm for professionals to share strategies and engage in dialogue around critical industry issues.
The conference highlights key initiatives in the realms of quality and regulatory with guidance for process validation, cleaning validation, and data integrity. Speakers for the 2019 ISPE South Asia Pharmaceutical Manufacturing Conference include experienced leaders from top organizations, like FDA, MHRA, AbbVie, Biocon, Pfizer, and Roche-Genentech—all with shared goals for the future of quality assurance.
Leaders in compliance will be able to develop solutions with industry members directly involved with facility designs, equipment, and operational management. Pharmaceutical manufacturing with advanced technologies presents complex challenges in regulatory approval of operations and product quality. The event facilitates the opportunity to learn and engage in industry discussion of crucial topics and innovations. Members of the industry can come together and discover manufacturing and industry best practices directly from leaders in regulation and business.
“Over two and a half days you will hear from regulators and industry professionals discuss important matters that are of interest to all of us,” said Dr. Rosa. “We will be talking about the corporate role in ensuring drug quality throughout the organization. We will also be talking about the regulatory expectations regarding submission applications, process validation, cleaning validation, and how to conduct investigations.”
The education agenda and session leaders chosen for the conference present not only strategies for scientific innovation, but for business, especially how executives can directly influence their organization’s progress towards higher quality. A key element to transforming facility operations is successful adaptation of complex systems and requirements. The pharmaceutical industry continuously searches for ways to implement strategies for better business management. Session leaders will also focus on new ideas that examine current challenges in conquering possible risks during agency inspection as a result of new modalities.
The conference also offers ways to transition from current operations to new strategies that are verified and meet regulatory expectations. By satisfying the demand for progressive advancements and risk management professionals in the industry who have the resources and experience can relate to one another and collaborate to change how manufacturers approach compliance.
According to Dr. Rosa, conference attendees also have the chance to talk about remediation specifically when a 4301 letter has been issued to their companies and discussion for avoiding future violations.
“We’re going to be discussing issues related to trends that we’re finding around the world during our inspections,” said Dr. Rosa. “The program promises to be interactive, to have roundtable discussions on case studies that everybody can relate to.”
The pharmaceutical manufacturing industry can benefit from improving their companies through reflection and carefully planned adjustments. The case studies presented include strategies and ideas for better technology incorporation and increased sustainability of approved production methods. Each scientific innovation calls for leaders in business and technology to remain efficient with modern facility designs, production equipment, and logistics.
I really encourage you to attend and take this opportunity to engage with regulators and industry experts. You can ask questions and you’re going to have the chance to learn about detailed regulatory expectations. You will benefit and grow from this unique experience. I hope to see you all in September in Bangalore, India.
Dr. Rosa
The 2019 ISPE South Asia Pharmaceutical Manufacturing Conference equips industry leaders with the tools and knowledge necessary for maintaining quality products and innovative engineering. Join ISPE in connecting global leaders driven to ensure pharmaceuticals are safe and to the highest standard of quality.
