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.

How mail delivers on sustainability

A white paper by By Sander Sondaal, Director Commercial Print Sales, Ricoh Graphic Communications, Ricoh Europe says that mail can be a sustainable choice. And by taking every opportunity to reduce the impact it makes throughout its lifecycle; it can contribute to a circular economy while playing an effective role in the marketing mix. 

That is according to the Royal Mail’s Marketreach which commissioned new research by environmental experts WSP to create a full carbon Life Cycle Assessment of Mail. 

It details the environmental impact and carbon emissions for each stage of mail from the forest to end of life including processing, design, production, delivery, and recycling. It quantifies the carbon emissions of some of the most commonly used mail formats. 

Delivery of mail is also considered. This is something the Royal Mail is hoping to address with the use of micro electric vehicles and drones for more remote locations. 

Other European postal service providers are also making strong progress in meeting their 2030 targets. By then Swiss Post is planning to be completely carbon neutral and Austria Post, which has the the largest fleet of electric vehicles in Austria, hopes to achieve 100% CO2-free delivery. 

The assessment by WSP also suggested the following ways to further manage carbon emissions:

• Ensure paper is sourced from certified forests – Certified paper from a well-managed forest, where trees are felled and replanted, absorbs more carbon dioxide (CO2) than a mature forest. Forests represent a proven carbon capture and storage system.
  
  
• Explore format size options – Weight, size, pagination, and type of paper matters. Smaller, simpler formats involve less processing, packaging and reduce carbon footprint when it comes to delivery. Impact can be made with short runs and personalised print featuring bold and creative designs. This is something Ricoh’s sheetfed colour digital printing presses can deliver with cost effective customised and individualised print as well as vibrant colour and metallic finishes using fifth toner technology.
  
  
• Create accurate and engaging personalisation – Careful management of mailing lists reduces waste and gets results. Royal Mail figures show that 95% of mail is engaged with and 87% of recipients describe mail as believable. Maintaining accurate data is crucial to this and can be achieved with software such as /data.mill Data Cleansing Solution. It automatically interrogates and corrects data inaccuracies quickly and simply, aiding a smooth and effective process.
  
  
• Careful design choice – Maximise circularity by caonsidering recycling and reuse. Use good imposition software that helps maximise substrate use to avoid excess waste while also reducing costs. Options include the easy-to-use FusionPro VDP Solutions suite of tools for simple design and production of personalised communications. 

Encourage end users to change their approaches too by helping your clients to become aware of the advantages of circularity. 

Also important is working with partners on the journey towards circularity. Together operations can make small steps towards big changes. This is where Ricoh can partner with you to identify what steps are possible and how best to take them.

Attend the 3rd Annual Computer Software Assurance 2023 to strengthen your CSV and Relook at the CSA Approach

Having organised two successful virtual editions, Eminence Business Media has thrived in addressing the most critical and crucial challenge areas of the Pharma Industry. Obeying the request of the pharma fraternity and living by the motto, "Learning is a constant process", to address the building apprehension and calm the nerves of the pharma industry, we are back with an exciting in-person edition. Eminence Business Media proudly announces the 3rd Annual Computer Software Assurance 2023, Live and In-stereo.

Computer System Validation (CSV) was adopted as a new technology by the pharma industry when technological advancements deterred the quality of systems. It has significantly ensured software quality and demonstrated that computer systems work as intended during inspections and audits. On the other hand, Computer Software Assurance (CSA) is said to be a futuristic mindset based on risk-based critical thinking. The logic promotes simple computerised onboarding with a unique operational context. 

The 3rd Annual Computer Software Assurance 2023 aims to strengthen and empower these systems. The idea is to create a program that explores the various elemental components to strengthen the CSV gameplan, address the challenge areas to boost the existing system and look at the futuristic mindset of CSA by analysing the knowledge gaps and bursting the myths. 

From meeting experts to learning from the regulators themselves, the program is designed to cover different aspects, addressing new challenges, presenting solutions & learning tools that deliver theoretical hypotheses and encourage practical application-based activities. 

BENEFITS OF ATTENDING
1. Interact with your peers and regulators concerning current guidelines.
2. Case study & live example-based sessions followed by group exercises.
3. Understand the CSA approach and strengthen your CSV.
4. Break the industry myths concerning CSA.
5. Dedicated Q&A rounds followed by each session.

KEY HIGHLIGHTS
1. Benefit from the 6-month support of continuous learning.
2. Carefully designed interactive and creative sessions to enhance holistic learning.
3. Networking activities to engage with like-minded individuals and industry leaders.
4. Upskill yourself to reap the desired results and overcome the challenges. 

DEPARTMENTS THAT CAN ATTEND
1. IT Quality Teams
2. CSV Teams
3. IT Compliance Teams
4. Corporate Quality Assurance Teams
5. Quality Assurance Teams 

DESIGNATIONS THAT CAN ATTEND
1. Managing Directors
2. Presidents
3. Vice Presidents
4. AVPs/VPs
5. Sr. General Managers, General Managers, Assistant General Managers
6. Team Leads

For more details, log on to https://pharmacsa.com

Novachrome Digital Design & Imaging expands existing Color-Logic license at no cost

In 2013, Novachrome Digital Design and Imaging, in the St. Louis suburb of Brentwood, Missouri, purchased Color-Logic software and began producing exciting metallic images on their FujiFilm Acuity and Canon Arizona large format presses. Recently, Novachrome purchased the new FujiFilm Prime large format engine. To increase Novachrome productivity and to broaden their ability to utilize Color-Logic for enhancing point-of-purchase, signage, packaging prototypes, and short run labels with metallic embellishments for their brand customers, Novachrome immediately submitted test forms from the new FujiFilm Prime for Color-Logic certification. According to Richard Ainge, Color-Logic Chief Technology Officer and developer of the Color-Logic System, “The printed test form sheets supplied by Novachrome indicated that their new FujiFilm Prime produces all Color-Logic embellishments and metallic colors in proper fashion.”

Commenting further upon the Novachrome installation, Color-Logic Director of Sales and Marketing Mark Geeves commented: "Unlike most print software today, Color-Logic provides licensees with a lifetime site license that enables Color-Logic clients to utilize our metallic embellishments and metallic color system on any device we support. When printers like Novachrome acquire new equipment--as Novachrome did with their new FufiFilm Prime--they can continue to enjoy the benefits of Color-Logic metallics and embellishments at no additional cost." 

Color-Logic develops color communication systems and software tool sets for a variety of special effect printing applications.  Color-Logic provides brand owners, product managers, corporations, and their advertising agencies the ability to differentiate themselves and their clients with a simple print production process that yields dramatic results. Color-Logic decorative effects utilize the existing workflows of printers and designers, yielding dynamic results without the use of special equipment. Color-Logic supports the value of print and works with designers and printers to enhance their printed media. For more information, visit www.color-logic.com