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United Journals and Conferences

3rd United Conference of Pharma Quality Validation and Product Manufacturing

Theme : Current Updates in Pharma Quality Validation and Product Manufacturing

Webinar on Pharma Quality Validation and Product Manufacturing | November 13, 2021

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Registration
Exhibitors
Sponsorships
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About The Conference

United Conferences gladly announces and invites global scientific community to attend the “3rd United Conference on Pharma Quality Validation and Product Manufacturing” a digital webinar that is going to be held on November 13, 2021. This conference boats a huge variety of Keynote Presentations, Plenary talks, Poster presentations, Video Presentations, and Career development programs.

3rd United Conference on Pharma Quality Validation and Product Manufacturing is a widest scientific integrative platform for Industrialists, Researchers, Educators, and Practitioners alike to present and explore the latest innovations, trends, and concerns as well as practical challenges encountered and solutions adopted in the fields of Pharma Quality Validation and Product Manufacturing. The webinar exposes pharmaceutical research on Process Validation, Quality assurance, Quality control, Quality management, Quality Validation, GMP etc. The most influential forum for pharma leaders in Marketing, Commercial, Medical Affairs, RWE, and Clinical.

Current Keynote Speakers

Ashutosh Singh
Ashutosh Singh

Head of Quality-Zifam Pinnacle/Quality Assurance Manager /Senior Quality Auditor/Quality consultant, Australia.

Elie Arslan
Elie Arslan

Manager, Technical Quality Assurance and Document Control at Ajinomoto Bio-Pharma

Achim Muller
Dr. Achim Muller

Product Development and Product Management Ceramics at Sigmund Lindner GmbH, Germany

Our Most Valuable Keynote Speakers

Gail Trauco
Gail Trauco

Advisory Committee Member COVID-19 FDA, Principal CEO The PharmaKon LLC, USA

Hashim Ahmed
Hashim Ahmed, Ph.D., WHO Fellow

Sr. Director-Head Of Formulation And Manufacturing, Avomeen, United States

Nashwa Nashaat

CEO & Co-Founder Nexus eHealth Formal regional Medical Director for J&J and Eli Lilly Novartis: Pharmacovigilance Lead

Penelope Przekop

Chief Compliance Officer At Engrail Therapeutics | CEO At PDC Pharma Strategy, USA

Jim Hauske
Jim Hauske

President And Founder At Sensor Pharma, United States

Timur Güvercinci
Timur Güvercinci

Director, Head Of External Supply Quality Processes And Development Bei Merck Gruppe Global Quality, Germany

Ravi Kalyanaraman
Ravi Kalyanaraman, Ph.D.

Director, Global Analytical Science & Technology - Pharma & Forensics Bristol Myers Squibb, United States

Danielle Drachmann
Danielle Drachmann

Executive Director At Ketotic Hypoglycemia International, Committee Member At The European Health Parliament, Patient Representative At The European Medicines Agency, Rare2030 EURORDIS, Europe

Stephan O. Krause
Stephan O. Krause

Head Of Product Quality Group At AstraZeneca Biologics, USA

Marieke Meulemans
Marieke Meulemans

CEO GCP Central B.V.,Amsterdam, North Holland, Netherlands

Karmen Trzupek
Karmen Trzupek

Director, Clinical Trial Services At InformedDNA, United States

Detlef Behrens
Detlef Behrens

Managing Director And Co-Founder At Bay Pharma GmbH Greater Kiel Area, Germany

Mathew Cherian
Mathew Cherian

Director & Senior Fellow Pharmaceutical Development, Hospira, A Pfizer Company, United States

Qihan Dong
Qihan Dong MD, PhD

Director, Chinese Medicine Anti-Cancer Evaluation Program, Sydney Medical School The Faculty Of Medicine And Health, The University Of Sydney, Australia

Li, Fengzhi
Li, Fengzhi

Faculty Member At Roswell Park Comprehensive Cancer Center, Roswell Park Cancer Institute, USA

James T. O'Donnell
James T. O'Donnell

Pharmacologist Drug Expert, Associate Professor At Rush Medical College, United States

Gareme Ladds
Graeme Ladds

CEO PharSafer Associates Ltd - Global Leaders In Drug Safety, United Kingdom

Avik Pal
Avik Pal

Founder & CEO, CliniOps, Fremont, California, United States

Liana Kasyan
Liana Kasyan

Founder/CEO And Principal PV Consultant At ETL Pharmacovigilance Center Ltd. Armenia

Eluemuno R Blyden

Founder/CEO At Avril Biopharma, Inc., United States

More Keynote Speakers

Sessions and Tracks

  • Pharmaceutical Analysis and Quality Assurance
  • Pharmaceutical Drug Validation
  • Pharmaceutical Product Development and Manufacturing
  • Process Validation Statistics
  • Computer System Validation
  • Good manufacturing practices
  • Pharma Manufacturing Process
  • Challenges in pharma manufacturing
  • GDP Good Distribution Practice
  • Pre-Formulation & Formulation Aspects
  • Good automated manufacturing practice (GAMP)
  • GMP/GCP interface & GMP audits
  • QRM: Quantitative Risk Management
  • Process Performance & Product Quality Monitoring System
  • Quality control and Quality assurance
  • Pharmaceutical Packaging and Logistics
  • Medicinal Chemistry
  • Total Quality management
  • Good Practice Quality guidelines and Regulations
  • Pharmaceutical Quality Control
  • Verification and validation
  • Statistical quality control
  • Statistical process control

Virtual Exhibitors

GCP-Central-Logo_white
GCP Central
ASTE Logo

ASTE Pharmaceuticals, Medical & Laboratory Supplies

TGMP Consulting

Informed DNA
Informed DNA
Diamond Pharmaceuticals
Gendron-Group
The Gendron Group

Webinar Registration Charges

  • Keynote/ Speaker Registration 249 USD
  • Speaker Registration 199 USD
  • Delegate Registration 129 USD
  • Student Delegate Registration 79 USD
  • Poster Presentation Registration 99 USD
  • Video Presentation Registration 99 USD
  • E-Banner Registration 99 USD

Who Can Attend

  • Managers, Directors, and VPs.
  • Pharmaceutical companies.
  • Hospitals, healthcare system & healthcare providers.
  • Health insurance companies.
  • Biotech companies
  • Medical device manufacturers.
  • Healthcare-related associations and foundations.
  • Industry influencers (solutions providers, educational organizations, government entities and venture capitalists).

Why Choose Us

  • Global & Local Expertise
  • Prospective Attendees
  • Larger worldview of the profession
  • We’re passionate about what we do
  • We focus on your career growth
  • Transparency in Communication
  • Open gateway towards INNOVATION
  • Strong sense of identification
  • Quality without compromise
  • Highly organised and structured scientific programs

Key Takeaways

  • Professional Worldwide
  • International Recognition of Researchers
  • Knowledge into Asset
  • Cognizance of leading Cutting – Edge technologies
  • Publication of Abstracts in preeminent supported journals
  • New Accomplishments with Edu – tech ideas
  • Exposure to the upcoming business trends
  • Free access to our forthcoming International events
  • Certificate of presentation with International signatories

United Pharma Technologies Collaborations and Associations

Gail Trauco
Gail Trauco
Advisory Committee Member COVID-19 FDA, Principal CEO The PharmaKon LLC, USA
Biography: The PharmaKon LLC specializes in clinical pharmaceutical product development and trials. It is a 100% woman owned business led by its CEO/founder Gail Trauco, R.N., BSN-OCN. The PharmaKon partners with biopharmaceutical and biotech companies, investigators, site staff, lab and technology vendors, and regulatory authorities to reinforce patient safety and access throughout every phase of research. All play a part in delivering the quality data that can drive promising compounds forward.
For nearly 30 years, The PharmaKon’s dedicated government and public health services group has successfully delivered clinical research services to various agencies, contractors and nonprofits in both prime contractor and subcontractor capacities within full compliance of all federal contracting requirements. Its services have supported the organizations in conducting therapeutic, vaccine and medical device studies on a global scale across all trial phases and therapeutic areas.

The PharmaKon has a unique understanding and connection to rural healthcare and underserved communities by way of Trauco’s personal experiences growing up on a family farm in her native North Carolina. Despite challenges with generational grief and poverty, Trauco persevered through high school and college at University of North Carolina at Chapel Hill and then began a life and career of her own as an oncology nurse. Trauco worked for the Chief of Surgical Oncology at Duke University Cancer Cener, Dr. Hilliard Siegler, a pioneer in the field of immunotherapy in 1957, whom she credits for her foundation of knowledge about medicine.

A registered Oncology nurse, pharmaceutical trials expert, and long-time Patient advocate, Trauco has spent four decades helping patients navigate the sea of red tape in the American healthcare system. Based just outside Atlanta, she has gained a reputation as a fierce advocate for patient’s rights and for resolving some of the most difficult medical cases in the currently crippled healthcare industry. As a lifelong healthcare professional and frequent on camera expert, Gail Trauco is equal parts Gloria Allred, Erin Brokovich, and Nancy Grace…with a small twist of Dog the Bounty Hunter.

For more information about Gail Trauco and The PharmaKonLLC visit:
https://thepharmakonllc.com/
Hashim Ahmed
Hashim Ahmed
Head of Formulation and Manufacturing at Avomeen. Wake Forest, North Carolina, United States
Biography: A pharmaceutical product development executive leader with wide experience in CMC/MS&T-product development-R&D expertise with in-depth diversified global technical and management experience. Expert in formulation/process/product development supply management; and quality assurance of pharmaceutical/consumer products. Over 26 years of experience in the United States in major, medium-to-small companies (Roche/Stiefel-GSK/Dr. Reddy's). Consumer Product Development and regulatory expert in a diverse portfolio of APIs and a wide range of dosage forms, with NDA/505b2/generic-ANDA experience.
In-depth experience in small and large molecules (proteins/peptides); orals (tablets, capsules [hard-soft gel]); controlled-modified release formulations; as well as/parenterals dosages. Expert in oral Liquids Emulsions-Suspensions, Lipids, Powders, Topicals, Transdermals, Ocular delivery, Intranasal, Aerosols. SKILLS: Proven Product Development/CMC/Regulatory Leader (26 years in the USA at different pharmaceutical technical and management capacities); currently managing general director at QLife the lead pharma company in Qatar.
Nashwa Nashaat
CEO & Co-Founder Nexus eHealth Formal regional Medical Director for J&J and Eli Lilly Novartis: Pharmacovigilance Lead
Biography: She has dedicated her career to improving the patients’ care and healthcare services. Inspired by the advancement in technology and her personal mission to serve patients, she has co-founded a company where the unmet patient’s needs drive the innovation for personalized technology-based solutions. In her role as a Chief Executive Officer and Co-founder for Nexus eHealth, she is committed to being a catalyst in the adoption of precision medicine through the Technology Enabled Connected Care solutions and building the healthcare technology capabilities, especially in the Middle East and Africa.
Prior to founding Nexus eHealth, being a physician; with PhD in Pediatric Oncology/Hematology, she devoted her passion to improve cancer patients’ lives and affordability of medicine by working with different global medical societies, NGOs and policy makers for more than 18 years. She has also worked for top multinational pharmaceutical, diagnostics and medical devices companies (Novartis, Eli Lilly and Johnson & Johnson) during the last 11 years where she took several global executive leadership roles in R&D, GxP auditing, medical affairs, patients advocacy and support programs, governmental affairs, business development, market access, healthcare policies and digital transformation strategies.

She was honored with 25 global awards for innovation, excellence and patient centricity. She authored more than 20 scientific publications. She serves as technical advisor and organizational leadership coach qualified by Glasgow university. She has been volunteering in different community services in Africa and a member in the Global Camper of Commerce and Industry (GCCI) that support the spirit of entrepreneurship. She is an Egyptian woman who constantly advocates the promotion of equality, diversity and inclusion & woman empowerment across the corporate world and the society as a whole.
Penelope Przekop
Chief Compliance Officer at Engrail Therapeutics | CEO at PDC Pharma Strategy
Biography: Penelope Przekop, MSQA, RQAP-GCP is the CEO of PDC Pharma Strategy, a consulting firm that focuses on strategic GxP regulatory and corporate compliance. She currently dedicates half of her time to serving as Chief Compliance Officer for Engrail Therapeutics, Inc. She has 30-plus years of broad and deep pharma industry experience and is known for her creative approaches to developing efficient quality management strategies that enable companies of all sizes to build upon their unique drug development history and strengths while ensuring compliance.
Penelope earned her B.S. in Biology from Louisiana State University and her M.S in Quality Systems Engineering from the Kennesaw State University. She is a frequent industry speaker and writer. She is the author of Six Sigma for Business Excellence (McGraw-Hill). Her upcoming book, 5-Star Career (Productivity Press, fall 2021), will relay how readers can apply the proven science of quality management to career development.
Biography: Executive director at Ketotic Hypoglycemia International. Her work started with the establishment of an international patient association where they are in close collaboration with national and international researchers, have written scientific papers and conducted research projects using a Citizen Science approach. Most recently, she entered the European Health Parliament and the European Medicines Agency as a Patient Representative for patients with rare hypoglycemia diseases. Furthermore, she have been working for EURORDIS (European Organization for Rare Diseases) to develop recommendations for Europes' rare disease policy in the Rare2030 project.
Stephan O. Krause
Stephan O. Krause
Head of Product Quality Group at AstraZeneca Biologics, USA
Biography: Stephan Krause, PhD, is currently Quality Director and PQL Team Leader in Development Quality, AstraZeneca Biologics. He is a results-driven leader with 20 years of technical, managerial, and executive experiences for quality and technical functions within global operations. He is a frequent conference presenter and author and has won multiple industry awards for his publications and leadership in improving industry best practices. Stephan was invited by FDA several times to present an industry perspective to the agency on relevant current topics. He is a member of PDA’s Board of Directors and is co-chair of AMTP Advisory Board and a member of the Advisory Board for Biopharmaceuticals and Regulatory Affairs/Quality.
Marieke Meulemans
Marieke Meulemans
CEO GCP Central B.V., Amsterdam, North Holland, Netherlands
Biography: She is a Founder and CEO of GCP Central since 2012 with over 15 years of experience within the clinical research world, and is the driving force behind the company vision.

Expertise:
•Development of practice-based and effective online GCP training for clinical research professionals.
•Setup and implementation of Learning Management Systems.

Specialties: eLearning development ; online GCP training; training needs analysis; process improvement; training management; blended learning; Good Clinical Practice; Clinical research rules & regulations; Wet Medisch Wetenschappelijk Onderzoek (WMO) training
Biography: Dr Dong was trained as a Physician then pursued a research career after completing his PhD at the University of Sydney. He continued as a Fogarty Fellow at the National Institutes of Health, USA. On returning to Sydney, he was appointed as the Head of the Cancer Biology Group. Currently, he is Associate Professor and the Director of newly-established Chinese Medicine Anti-cancer Evaluation Program at the Medical School in University of Sydney. He has published 81 papers (3,800 citations) in journals with an average Impact Factor of 4.1. He has been the first or senior author on 70% of them. His team was the first to discover that in prostate cancer cells the expression of the native inhibitory gene of phospholipase decreased. This content has been published three times in "Cancer Research" and "Clinical Cancer Research", and has been included in the latest European edition of "Encyclopedia of Cancer".
Biography: Fengzhi Li became a faculty member at Roswell Park Comprehensive Cancer Center (legal name: Roswell Park Cancer Institute, the first cancer institution in the US history and is a US NCI-designated comprehensive cancer center) in 2001 after finishing his postdoctoral training in Dr. Dario C. Altieri’s laboratory at Boyer Center for Molecular Medicine, Yale Medical School where he focused his research on the characterization of the function and expression regulation of a newly discovered antiapoptotic protein named survivin (a novel member of the inhibitor of apoptosis protein family). In 2006 he has been promoted to Associate Professor of Oncology at Roswell Park. As a chief scientist, he leads his lab using the survivin gene as a target and biomarker for targeted drug discovery. He has transitioned his Roswell Park cancer research lab from basic to translational cancer research over the past decade. His current research interests focus on targeted anticancer drug discovery, development and mechanism of action (MOA) studies. His research has been supported through federal agencies (NIH/NCI, DOD) as well as other public/private foundations and partnerships. He has published over 80 publications (h-index, 47 and i10-index, 73) with a total citation of over 13,000 times. He is the editorial board members in several academic journals including J Exp Clin Can Res (2019 IF: 7.068), Am J Transl Res (2019 IF: 3.375) and Int J Mol Sci (2019 IF: 4.556). He is also the Chief Scientific Officer (CSO) of Canget BioTekpharma LLC (www.canget-biotek.com) and helps Canget to develop innovative targeted anticancer drugs (high efficacy with low toxicity) for benefiting cancer patients.
Biography: Graeme Ladds has worked in Global Pharmacovigilance and Medical Affairs for the last 30 years working with many top ten Pharma in senior positions. He has worked in all areas of Pharmacovigilance and has designed and improved many IT solutions to aid both Medical Affairs and Pharmacovigilance. Graeme is also an experienced GCP/PV auditor having audited many Companies globally as well as helping Companies in Regulatory Inspections. He now works in his CRO - PharSafer Associates Ltd
Liana Kasyan
Liana Kasyan
Founder/CEO and Principal PV Consultant at ETL Pharmacovigilance Center Ltd. Armenia
Biography: Founder/CEO and Principal PV Consultant at the ETL Pharmacovigilance Center Ltd., - Pharmacovigilance Instructor at the Open Education Office of the American University of Armenia, - Member of International Society of Pharmacovigilance (ISoP), - International Editorial Board Member for the Journal of Pharmacovigilance and Drug Research (JPADR), - Reviewer of Master Тheses at the Faculty of Public Health of Yerevan State Medical University, - Board Member of Armenian Association of Specialists in Evidence-Based Medicine (AASEBM), - Co-founder of “Do not Harm’’ Health NGO.

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