Pharma Impurity Conclave 2023: Dedicated to solving the stubborn challenges

A fresh dawn emerges, revealing another intriguing program, but the familiar and persistent challenge remains steadfast. In response to the urgent concern plaguing the pharmaceutical industry, Eminence Business Media takes immense pride in announcing the highly anticipated Pharma Impurity Conclave 2023, a symposium dedicated to solving the stubborn challenges by complying with the esteemed pharma fraternity, on the 7th and 8th of September.

While the exhaustive evolution of medicines has led to remarkable breakthroughs, the R&D journey has also encountered numerous challenges, particularly concerning drug impurities. With the advent of various discoveries and synthesis processes, various contaminants have been observed in drug formulations, presenting an array of complex challenges and disputes. However, driven by unwavering determination, the resolute pharma industry has confronted this diversity with remarkable efficiency and precision. Nevertheless, 2018 had a new obstacle in store - NITROSAMINES, which remains the most prominent concern for the industry.

Pharma Impurity Conclave 2023 aspires to surmount the most widely discussed challenges with unwavering efficacy, offering concrete solutions through in-depth exploration of the various layers of obstacles, thereby fortifying drug impurity profiling practices by evaluating their sources and processes. Though industry professionals are already familiar with multiple mechanisms of identification and risk assessment, the missing piece of the puzzle lies in quantifying uncertainty.

From delving into practical case studies to comprehending the latest guideline updates, this meticulously curated program is designed to address the most recent and pressing challenges concerning impurity mechanisms, adopting cutting-edge and distinctive learning tools. Attendees will have the unique opportunity to learn from distinguished experts and apply their theoretical hypotheses in the stimulating Pharma Impurity Conclave 2023 setting.

Thus, a new day brings forth another captivating program, wherein the timeless challenge is met with a fresh perspective and innovative approach, promising novel insights and solutions.

WHY ATTEND?

1. Interact with your peers and experts and learn about the different mechanisms.
2. Case study & live example-based sessions followed by group exercises.
3. Dedicated Q&A rounds followed by each session to solve all queries and doubts.
4. Benefit from the 6-month support of continuous learning.
5. Carefully designed interactive sessions with apt learning tools to enhance holistic mindset.
6. Networking activities to engage with like-minded individuals and industry leaders.

WHO CAN ATTEND?

From Managing Directors, Presidents, Vice Presidents to Sr. GMs, GMs and Mid-level management members, everyone can reap the benefits of this platform to learn and network with industry peers.

DEPARTMENTS

1. R&D
2. Analytical R&D
3. Quality Teams
4. Regulatory Teams
5. Manufacturing Teams

Hemlock Printers propels its customers forward with an HP Indigo 100K Digital Press

One of the largest and most recognized printing companies in North America, Hemlock Printers, enhances its digital print capabilities, automates processes, and ensures high-quality prints for its customers with the HP Indigo 100K Digital Press. With this investment, the company has been able to transform its product offering and improve productivity across the entire business.

Based in Burnaby, Canada, Hemlock Printers is diligently focused on being the industry’s most innovative and sustainable print provider, servicing a diverse range of customers and industries. The company has a long history of investing in advanced printing technologies which provide exceptional product quality, streamlined workflows and productivity improvements. The HP Indigo 100K Digital Press delivers on these benefits, strengthening Hemlock’s product portfolio and customer value-proposition in the process.

Hemlock Printers was founded in 1968 and has since operated as a progressive, family-owned business that prioritizes customer value, technological innovation, and sustainable leadership. Fifty-five years later, this remains true, with the company’s passion for continuous innovation and technological advancement a key component to their success.

With the addition of the HP Indigo 100K Digital Press, which is manufactured carbon neutral, the company has been able to build upon its environmental initiatives. Most notably, the Indigo 100K Digital Press contributes to Hemlock’s waste reduction efforts thanks to the material efficiency of the technology. Significant reductions in makeready and run waste, commonly greater than 90%, result in an efficiently produced finished product with a lower environmental footprint.

When discussing this latest addition, Richard Kouwenhoven, President & CEO of Hemlock Printers said: “The Indigo 100K is a very exciting addition to our pressroom enabling us to efficiently produce short run projects at an extremely high-quality level with the same range of paper options and product formats our clients are accustomed to. It is a versatile machine that really suits our business and will open new workflow automation opportunities for us in the future.”

Furthermore, Rob Baker, Director of Manufacturing at Hemlock emphasized, “The HP Indigo 100K Digital Press has also created new job opportunities for our employees. Skilled offset press operators have made the switch to operating the 100K Digital Press, expanding their roles since the installation. Knowing we can streamline tasks and allow our employees to grow at the company with the implementation of these products is truly invaluable.”

Hemlock Printers showcases how powerful digital print technology can be to modernize processes, propel business growth and opportunity, and meet the growing demand of printing services. 

ERP Solutions for Small & Medium Engineering from SourcePro Infotech

Following ever increasing customer needs and the current volatile situations there are plethora of other challenges you might be going through in your business processes. At SourcePro Infotech, we are addressing these challenges of Business Enterprises like yours. Over last 20 years our ERP product has undergone multiple technological and functional evolutions, and that journey has now culminated into new version as “New Horizon. It is a state-of-the-art cloud-enabled ERP product. New Horizion is now accessible anywhere on any OS, on any device and at any time. Our New Horizon ERP takes away all the manual hassle and enables you to focus on your company goals.

SourcePro is a synergised team of highly skilled industry experts with the aim of optimising businesses through advanced ERP software products. Our customer-focused approach and commitment to innovation have kept us going strong for the past 28 years, and has raised the bar for software solutions across the industry. As technology advances at a rapid pace, we have developed a foresight that ensures that our products and services are future-ready and on the cutting edge.

With technical expertise coupled with a strong understanding of business, we have pushed the envelope to create ERP products that seamlessly integrate with your existing processes. That is what makes us one of the top ERP software companies in India—one that has been expanding value for businesses across a wide range of industries for over two decades.

In addition to Indian businesses, MNCs and joint ventures hailing from America, Australia, Germany, and Switzerland rely on SourcePro’s innovative, efficient, and robust software for their Indian operations.

Daco Solutions launches inspection slitter rewinder at Labelexpo Europe 2023 – Stand 4A53

UK converting equipment manufacturer Daco Solutions will launch its SRV350 inspection slitter rewinder at Labelexpo Europe 2023.  The servo-driven machine features an inspection system from Nikka, closed-loop unwind tension control, and a fully automatic slitting unit with servo-driven positioning of the knives. It runs at speeds of up to 300m/min with a 350mm web width and 800mm unwind diameter. An optional accumulator can be added, so any labels replaced on the web will pass back underneath the camera to ensure 100 percent inspection. 

‘This is our highest-specification machine in our slitter rewinder portfolio,’ said Daco’s sales manager Mark Laurence. ‘We have had great success over the years with our more economical models, but we were keen to expand our product range and be able to offer high quality equipment to even the biggest label converters. Adding an inspection system greatly reduces waste and guarantees a high-quality output. A version of the machine with a three-spindle semi-automatic turret, the PLR-V model, is already available and has sold steadily over recent years.’ 

Also on display in Brussels will be Daco’s PLD350 semi-automatic turret rewinder for plain label production and a PLR430 semi-automatic turret rewinder for slitting with integrated 1m unwind with roll lift. Daco Solutions, which has installed equipment in 56 countries around the world, has exhibited at every Labelexpo Europe show since the company’s foundation in 2001.

Pharma Regulatory Conclave 2023: The Unique Inaugural Program Taking Bold Steps!

The Inaugural Regulatory Program of Eminence Business Media, Pharma Regulatory Conclave 2023 set a very high benchmark for conferences based off learning and rejuvenation. The program was designed with a unique framework with one day virtual day program on 30th June and a two-day in-person conference at Hilton Resort, North Goa on July 5th - 6th. With the unique theme on the Day 2, “Patrao”, having dedicated Q/A rounds after every session, case study solving exercises, within the quaint locality in Goa amidst the monsoon, this regulatory program took a very distinctive and bold step by not only addressing current challenges of the pharma regulatory industry but also acknowledging the unaddressed yet crucial focus of emerging markets.

The virtual day was designed to give theoretical understanding to the delegates about the various required regulatory processes like Regulatory Intelligence, Dossier Filings and GDUFA III guidelines delivered by Mr Prafulla Nandi from Cadila Pharma, Ms Minoo Biju from Piramal Pharma Solutions and Mr Adam Freeman from exFDA Consultants. The program also included a very interesting panel discussion of international experts from regulatory bodies of USA, South Africa, and Latin America. Mr. Larry Stevens from USFDA, Ms Emtia Perold from SAPHARA and Mr Ivan Calderón from COFEPRIS shared their experience and gave insights about the practicality of having a common dossier for emerging markets. Pharma Industry veterans like Dr Udaykumar Rakibe from PharmaMantraTM and Dr Sanjit Singh Lamba from Biocuris Pharma were also a part of the discussion and presented the Indian Pharma perspective with their standing within the global market.

The unique design of the program facilitated Eminence Business Media’s commitment to delivering excellence by learning. The virtual program was corroborated with the in-person conference with a unique case study solving exercise which focused on emerging markets regulatory requirements. The session was designed by Mr. Rajeev Mathur from Sun Pharma and was facilitated by Mr. Udaykumar Rakibe and Mr. Rahul Jain at the in-person conference.

Delegates and attendees were working in groups and solving the case study for over a week to present their solutions with the groups on Day 2 of the conference. The group exercise was fruitful with unique frameworks being presented by the delegates as a solution to the cases. The two day in-person conference further thoroughly discussed topics like regulatory requirements of complex generics, drug approvals in ICH countries, life cycle management of a drug, post approval changes, among others. Experts like Mr. Rahul Gupta from USV, Ms Meenakshi Jain from Sandoz, Ms Adity Sen Pal from Indoco Remedies and Ms Vandana Singh from Biocon delivered the crucial topics and interacted with the audience by accommodating their questions. Mr Arani Chatterjee from Cadila Pharma and Mr Praveen Cherukupalli from Innovare Labs discussed the clinical trial regulatory requirements and the nitrosamine requirements which are the pain points for the industry. The in-person conference also witnessed a panel discussion on the ever-evolving challenges of regulatory affairs moderated by Dr Sanjit Singh Lamba. The expert consisted of panel members like Dr Mayur Parmar from Govt of Gujarat, Dr Venkat R Naidu from Dr. Reddy’s Laboratories, Ms Adity Sen Pal, and Mr Rahul Gupta.

Having understood the unique requirements of the regulatory professionals to clarify their doubts and addresses their questions, the program accommodated a panel of experts namely, Mr Prafulla Nandi, Mr Arani Chatterjee and Mr Praveen Cherukupalli to solely address the queries of the delegates and attendees. The in-person conference also had sessions catering to gap mitigation between regulatory and other departments by having a dedicated session on soft skills delivered by Mr Sushil Barkur. Further, the rejuvenating activity of the program was also designed with the underline learning of importance of working in collaboration focusing more on regulatory professionals being facilitators than inspectors.

Eminence Business Media plans to announce the dates for the fourth edition of the Computer Software Assurance in 2024, so stay tuned for updates on their LinkedIn page and event website.

EBM announces 3rd Annual Cleaning Validation 2023- A Practical Approach

Cleaning validation is an essential process in the pharmaceutical industry that ensures that all equipment used in the manufacturing process is cleaned to prevent cross-contamination and ensure product quality. Eminence Business Media acknowledges the need of focused training on the main pillars of an effective master cleaning validation plan and introducing a program that covers elaborated discussions and case studies for cleaning cycle, cleaning chemistry, regulated equipment, test limits and periodic monitoring; and announcing 3rd Annual Cleaning Validation 2023- A Practical Approach, scheduled for August 24th – 25th, followed by a virtual session on September 2nd. This program offers 2-day learning followed by 1 day follow up virtual session, this way the attendees can implement the 2-day learning in their professional lives and come back with follow up questions during scheduled virtual training.

From the insightful discussions and interactions between the eminent speakers and attendees we have ensured the entire training program would be very communicative. We at Eminence Business Media believe that learning should not stop only by brush ups or doubt solving, it should be evaluated by Case studies. Hence, after deliberating with experts with immense experience in the industry, we have drafted important subject of Cleaning Validation with practical learning.

WHY ATTEND?

• Analyse the best of recent trends and advanced innovations for more efficient Cleaning Validation. 
• Learn the practical approach with case study discussions and live examples.
• Discuss your queries at the live Q & A sessions and reap the benefits from the extended 6-month support for continuous learning even after the event.
• Take advantage of follow-up virtual session to address real time challenges after implementing 2 day in-person learning.
• Share the dais with the industry leaders and network with your peers to understand what they do differently to be successful.

WHO WOULD ATTEND?
QA/QC: To ensure products meet the required quality standards and comply with regulatory requirements

Manufacturing & Production: To ensure equipment is properly cleaned and that the manufacturing process is not compromised by cross-contamination.

Regulatory Affairs: To ensure company complies with regulatory requirements for Cleaning Validation as well, amongst other processes.

Engineering and Maintenance: To ensure the maintenance and repair of the equipment used in the manufacturing process.

Analytical and R&D: To develop and validate analytical methods used in the cleaning validation process.

Pharma industry strengthening the CSV & CSA approach with the 3rd Annual Computer Software Assurance 2023

The Pharma Computer Software Assurance 2023 conference’s third edition set remarkably high session originality and creativity standards, providing attendees with an engaging program full of valuable learning opportunities. This two-day in-person event occurred at Novotel Mumbai, Juhu Beach, on June 22nd and 23rd, 2023. The conference’s unique program design achieved a balance between CSV and CSA.

The conference commenced with a Keynote address from Eminence Business Media’s Managing Director, Ms Guneet Kaur Hayer. Her warm welcome set the expectations for the exceptional two-day learning program. The program began with an insightful Panel Discussion moderated by Mr. Ken Shitamoto, titled CSV or CSA. Esteemed panellists included Mr. Francisco Vicenty from USFDA, Dr. Mayur Parmar from Govt of Gujarat, Mr. Ravi Kalla from Anthem Biosciences, and Mr. Sanjeev Dharwadkar from Pharma Tech Consulting. This session explored various aspects of CSA and CSV approaches in the pharmaceutical industry, providing valuable insights from a regulatory as well as manufacturing perspective.

Following the panel discussion, attendees had the opportunity to engage in a Fireside Chat with Mr. Francisco Vicenty, enabling direct interaction and the chance to ask questions to the FDA. The day continued with a session delivered by Ms. Deepa Pangaonkar from Wockhardt, focusing on the challenging topic of ‘Quality Testing and Evidence’ within CSA & CSV. Mr. Vivek Bansal from Biological E. then led an engaging session on ‘Change Control and Change Management,’ an essential topic for understanding the transition from CSV to CSA. During the conference, partners such as Persistent Systems, Techsol Life Sciences, RxCloud, Rephine, and Conval Group had the opportunity to participate in a unique networking session. Additionally, Mr Ravi Kalla designed a process activity for the delegates, promoting collaboration and emphasizing the importance of unified systems.

The second day of the conference commenced with an intriguing session on Digital Validation Systems by Mr Khaled Moussally from Compliance Group. This session highlighted the significance of going paperless and explored various platforms offering practical solutions. Subsequent sessions focused on facilitating the transition from CSV to CSA. Mr Ken Shitamoto delivered a vital talk on Critical Thinking, followed by Mr Pranav Gadre from Reliance Life Sciences, sharing his experiences working in IT and QA teams. The latter half of the day concentrated on topics such as Industry 4.0 and Data Integrity Risk Assessment (DIRA) designed by Mr Rajesh Thempadiyil from Dr. Reddy’s Laboratories through a group exercise that stimulated intense discussions and generated vital takeaways.

True to the distinctive nature of the Eminence Conference, the program concluded with a unique

and invigorating activity designed to encourage delegates to ask questions in a rapid-fire fashion. The representatives debunked over 100 myths in an impressive feat within 45 minutes. The day concluded with a unique networking activity, where delegates and speakers could bond over cold beers and 360° Cam experiences.

Eminence Business Media plans to announce the dates for the fourth edition of the Computer Software Assurance in 2024, so stay tuned for updates on their LinkedIn page and event website.

IntraPac India Moves to India Expo Centre, Greater Noida, NCR Delhi

The Indian Printing Packaging & Allied Machinery Manufacturers' Association (IPAMA) announces a venue change for the upcoming IntraPac India exhibition. Due to the unavoidable circumstances and some technical reasons, IPAMA has decided to shift the event to India Expo Centre, Greater Noida, NCR Delhi. 

IntraPac India, an exclusive exhibition focused on the Packaging Industry, will now take place at India Expo Centre from 14th to 17th March 2024. This premier event will showcase a wide range of packaging solutions, machinery, and allied products, including plastic packaging, metal packaging, glass packaging, paper packaging, filling, capping, sealing, biodegradable packaging, protective packaging, automation and robotics, tube packaging, mono cartons, pharmaceutical packaging, traceability & tracking, logistics, film, moulding, and many more. 

In light of the venue change, IPAMA has revised its rates and is offering exhibitor spaces at a highly economical price to packaging companies. This move aims to encourage participation from a larger number of MSME Units in the Exhibition. The rates for subsequent editions will also be reviewed and adjusted to ensure greater affordability. 

IPAMA has reserved four halls, covering a total area of 14,000 square meters, at India Expo Centre. Within just one month of the exhibition announcement, 48 companies have already confirmed their participation and secured their spaces. 

To incentivize early registration, IPAMA has introduced an Early Bird Discount of Rs. 1000/- Per Sq. Mtr. The last date to avail of this discount is mentioned on the official website. Furthermore, exhibitors will also be eligible for a special motivational discount, subject to approval by IPAMA's governing council committee. Additionally, membership discounts will be provided based on the tenure of membership. 

IntraPac India at India Expo Centre promises to be an exceptional gathering of industry professionals, providing a platform to explore the latest trends, innovations, and business opportunities in the packaging sector. 

The Indian Printing Packaging & Allied Machinery Manufacturers' Association (IPAMA) is a leading industry association that represents the interests of the printing, packaging, and allied machinery manufacturers in India. IPAMA strives to promote growth, innovation, and collaboration within the industry through exhibitions, seminars, workshops, and other initiatives. 

EBM announces the Pharma Regulatory Conclave 2023 at Hilton, North Goa from 5th - 6th July, 2023

Complying to ever evolving global requirements of emerging markets and meeting regulatory expectations of a well evolved landscape is vital to maintain the safety & efficacy of the new & existing drugs, and accuracy of product information. Eminence Business Media acknowledges this need and after conducting several successful conferences, liked, and appreciated by the pharma fraternity, we are coming up with the inaugural program Pharma Regulatory Conclave 2023 in Hilton, Goa. 

This program will be a reference guide for identifying the challenges and underlying opportunities in the regulatory framework, for overall growth in aspects of essential documentation, preparing the dossier efficiently and filing the global application, followed by unparalleled business & research opportunities, networking platforms, and access to new trends in the Indian pharma world. 

At this forum, top issues highlighted by the regulators will be addressed by the pharma experts & key people from regulatory bodies, as they share their insights, experiences and use case studies on updated regulations & policies, maintaining data in the information system, ensuring compliance with regulations, and evaluating applicable laws to determine impact on company activities. 

This is your best opportunity to arrive and meet the biggest array of members from the regulatory and related departments. Network with your industry peers, discuss the new trends, strategies, and solutions, and meet the apt partners to take home the most relevant learning to help you grow and meet your company goals. Let's connect and together build the Pharma Regulatory Conclave 2023. 

WHY ATTEND?
1. Take advantage of the dedicated day 0 webinar a week prior to the in-person event, with extensive opportunities to clarify your doubts.
2. Discuss your queries during dedicated Q&A sessions and reap the benefit from the extended 6-month support for continuous learning.
3. Solve live case studies & deliberate on the shortcomings and practical solutions.
4. Network with the industry leaders to understand what they do differently to be successful.

WHO SHOULD ATTEND?
MD, Directors, CXO’s, President, Sr. VP’s, VP’s, GM’s, Heads, Leads, Managers and professionals from:
1. Regulatory Affairs
2. Regulatory Operations
3. Research & Development
4. Manufacturing & Supply Chain
5. Quality Teams
6. Academia
7. Everyone who needs to comply with regulatory guidelines, managing database, product information and filing dossier. 

For more information, log on to http://www.thepharmaregulatory.com/

Co-creation, collaboration, and commitment – a FESPA reflection by Axel Stuhlreiter

In these post Coronavirus times, all eyes turn to major industry events so we can try to draw conclusions about the prevailing mood and levels of confidence. Well, if this year’s FESPA Global Print Expo in Munich is a good barometer, we have cause for optimism. The appetite for meeting, greeting, and yes investing was palpable along the thronged aisles and stands.

On the Ricoh, textile-oriented, stand, the atmosphere was as upbeat as anywhere. Throughout the four days last week, there was a steady stream of visitors – textile creatives and other specialists, Print Service Providers, partners, journalists, and analysts keen on seeing for themselves how Ricoh’s offer to the garment printing industry is evolving through both Direct to Garment and Direct to Film solutions. 

We were delighted to demonstrate a range of solutions. Some established, some brand new, and welcomed all the constructive feedback. Co-creation is one of our guiding principles. It wasn’t just DTG and DTF though as there were many conversations about Ricoh’s inkjet print head expertise and how it could enhance manufacturers’ production capabilities. Our partners Fruit of the Loom and Russell Athletic made Ricoh’s booth a truly collaborative venture. 

It was very clear that these brands’ all-encompassing commitment to sustainable garment production echoed our own environmental philosophy. And that the partnership is founded firmly on shared values. 

Perhaps though what will live longest in memories will be our celebrated Manga artist, Uchida, painting, over the course of the show, a wonderful Manga scene. She attracted crowds of onlookers who watched the picture emerge on the three by two metre canvas. Many of them then chose an individualized printed T shirt with their preferred Manga design to take away as a memento. 

So, I and my Ricoh colleagues can now reflect fondly on a great experience at FESPA. It was successful for us but also of course very importantly, it worked for our industry too.