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December 2014

ISPE Tampa Training Event
December 1-4, 2014
Embassy Suites Tampa-Airport/Westshore - Tampa, FL

Improve your skills with ISPE Training and learn how to maintain product quality, improve manufacturing efficiency and CGMP compliance. ISPE courses are designed to delve deeply into a specific topic to provide you with skills and knowledge using lecture, breakouts and exercises to deliver tangible take-a-ways that you can immediately apply on the job. COURSE TOPICS INCLUDE: GMP Auditing, Cleaning Validation, Risk PCS, Q7A, Risk MaPP, QRM, and PV/PQS.

2-day In-person Seminar on Applied Statistics for QA, QC, Manufacturing, and Design Control at Los Angeles, CA
December 4 - 5, 2014
DoubleTree by Hilton Hotel Los Angeles Downtown

The 2-day seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics. Basic vocabulary and concepts are then reviewed and discussed. 

Why should you attend? Almost all design and/or manufacturing companies evaluate product and processes either to establish product/process specifications, to QC to such specifications, and/or to monitor compliance to such specifications. The various statistical methods used to support such activities can be intimidating to master. If used incorrectly, such methods can result in new products being launched that should have been kept in R&D; or, conversely, deciding to not launch a new product because of incorrectly calculated product reliability or process capability. In QC, mistakenly chosen sample sizes and inappropriate statistical methods may result product being rejected that should have passed, and vice-versa. This seminar provides a practical approach to understanding how to interpret and use a standard tool-box of statistical methods, including confidence intervals, t-tests, Normal K-tables, Normality tests, confidence/reliability calculations, AQL sampling plans, measurement equipment analysis, and Statistical Process Control. Without a clear understanding and correct implementation of such methods, a company risks significantly increasing its complaint rates, scrap rates, and time-to-market; and significantly reducing its product and service quality, its customer satisfaction levels, and its profit margins.

R&D Engineer Areas Covered in the Session: FDA, ISO 9001/13485, and MDD requirements related to statistical methods • QA/QC processes (sampling plans, monitoring of validated processes, setting of QC specifications, evaluation of measurement equipment) • Manufacturing processes (process validation, equipment qualification) • Design Control processes (verification, validation, risk management, design input) Course Outline: Day One: Lecture 1: Regulatory Requirements Lecture 2: Vocabulary and Concepts Lecture 3: Confidence Intervals (attribute and variables data) Lecture 4: t-Tests and related "power" estimations Lecture 5: Confidence/Reliability calculations for Proportions Lecture 6: Confidence/Reliability calculations for normally distributed data (K-tables) Lecture 7: Normality Tests and Normality Transformations Day Two Lecture 8: Reliability Plotting (e.g., for non-normal data and/or censored studies) Lecture 9: Statistical Analysis of Gages (introduction to Gage R&R, Gage Correlation, etc.) Lecture 10: QC Sampling Plans (attribute AQL plans and alternatives to such plans) Lecture 11: Statistical Process Control (introduction, with focus on XbarR charts) Lecture 12: Process Capability Indices calculations (Cp, Cpk, Pp, Ppk) Lecture 13: Implementation Recommendations About Speaker: John N. Zorich is a Statistical Consultant & Trainer, Ohlone College & SV Polytechnic. John N. Zorich, has spent 35 years in the medical device manufacturing industry; the first 20 years were as a "regular" employee in the areas of R&D, Manufacturing, QA/QC, and Regulatory; the last 15 years were as consultant in the areas of QA/QC and Statistics. His consulting clients in the area of statistics have included numerous start-ups as well as large corporations such as Boston Scientific, Novellus, and Siemens Medical. His experience as an instructor in statistics includes having given 3-day workshop/seminars for the past several years at Ohlone College (San Jose CA), 1-day training workshops in SPC for Silicon Valley Polytechnic Institute (San Jose CA) for several years, several 3-day courses for ASQ Biomedical, numerous seminars at ASQ meetings and conferences, and half-day seminars for numerous private clients. He creates and sells formally-validated statistical application spreadsheets that have been purchased by more than 75 companies, world-wide.

DATE, VENUE & PRICE: Location: Los Angeles, CA Date: December 4th & 5th, 2014 Time: 9 AM to 6 PM PST Venue: DoubleTree by Hilton Hotel Los Angeles Downtown Address: 120 South Los Angeles Street, Los Angeles, California, 90012, USA Price: $1,295.00 Register now and save $200. (Early Bird) Until October 31, Early Bird Price: $1,295.00 From November 01 to December 02, Regular Price: $1,495.00 Registration Link - Contact Information: NetZealous LLC, DBA GlobalCompliancePanel, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Phone: 1800 447 9407 Fax: 302 288 6884 Email: Website:

2-day In-person Seminar on The Drug Approval Process: Preparation and Processing of INDs and NDAs at Hong Kong
December 4 - 5, 2014
Intercontinental Hong Kong

This seminar presents all the requirements to obtain FDA permission to market a Drug product in the USA. To find out the fastest and most cost-efficient way onto the USA marketplace this seminar is a must. This seminar introduces FDA and its laws, regulations, policies and guidelines. Starting with Drug development this seminar continues with discussions on the testing requirements for new chemical entities (NCE) and the IND system which leads to Drug clinical testing. Discuss is the format and contents of an IND. All Phases of clinical testing are covered - Phase 0, Phase 1, Phase 2, Phase 3 and Phase 4 testing. Then the NDA system is addressed. The format and content of an NDA are covered. The FDA submission review system is covered for INDs and NDAs. Also addressed are FDA post-approval requirements. With this seminar attendees get a better understanding of the FDA Drug Approval Process and the underlying scientific and regulatory principles involved. 

Course Outline: Day One Lecture 1: Introduction to FDA • History • Laws • Regulations • Policies • Guidelines • Overview of FDA Lecture 2: Definitions • Lecture 3: Drug Classification • New Drug, Biologic or Generic Drug • Drug status and strategy Lecture 4: Drug Development Process • Drug development outline Lecture 5: IND Process • IND format and content • FDA Form 1571 • FDA IND submission review process • IND amendments Day Two Lecture 6: Drug Clinical Trials • FDA clinical logic/rationale • Phase 0 Clinical Studies• Phase 1 Clinical Studies • Phase 2 Clinical Studies • Phase 3 Clinical Studies • Phase 4 Clinical Studies Lecture 7: NDA Process • NDA format and content • FDA Form 356(h) • FDA NDA submission review process • NDA amendments Lecture 8: Post-Approval Requirements • Requirements of the approval letter • Registration/Listing • NDA Supplements Speaker Profile: Albert Ghignone, Chief Executive Officer and President, AAG Incorporated Albert A. Ghignone MS, RAC is the CEO of AAG Incorporated.

For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical. He has been responsible for regulatory submissions, registrations, FDA liaison, clinical studies, compliance activities and FDA training. He also has expertise in the assessment of product and facilities for due diligence relative to FDA requirements. He lectures throughout the world on numerous FDA related matters. He is a consultant to FDA and trains FDA Field Force (those who conduct FDA inspections) on GCP, GLP and GMP). In addition to training FDA personnel Mr. Ghignone also consults/trains for Drug, Biologic and Medical Device companies, US Army HIV Research Group, NIH AIDS Group, US Army Surgical Research Group and the Naval Medical Research Group.

Location: Hong Kong Date: December 4th & 5th 2014 Time: 9:00 AM to 6:00 PM Venue: INTERCONTINENTAL HONG KONG Address: 18 Salisbury Road, Kowloon, Hong Kong Price: $1,595.00 (Seminar for One Delegate) Register now and save $200. (Early Bird) Until November 15, Early Bird Price: $1,595.00 From November 16 to December 02, Regular Price: $1,795.00 Registration Link: Contact Information: NetZealous LLC, DBA GlobalCompliancePanel, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539 Email:

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January 2015

Asia Pharma Expo 2015
January 8 - 10, 2015
Bangabandhu International Conference Centre, Dhaka. Bangladesh

  • Expected 470 Exhibiting Companies
  • Over 9000 Trade Professionals
  • From 28 Countries
  • On 8,500 Sq. Mt. Floor-space

One of the fastest growing pharma economy of the world is Bangladesh.  The rapid growth rate to meet the Demand & Supply statistics of India, Bangladesh, Nepal, Pakistan, Bhutan, Myanmar, Thailand, and Indonesia has attracted the global attention. Over-all growth rate of the South Asian Pharma Industry is 14% and No. of Formulators are More than 24,000 With the highest exports of the formulation, Bangladesh offers all the advantages for its strategic location in the South Asian pharma region Bangladesh remains on top with 97% of the total pharma production being exported to over 62 countries. Based on WTO meet / Doha declaration, Bangladesh will also be able to produce drugs which are still under Patent protection until year 2,015. GPE EXPO PVT LTD is organizing 12th International exhibition on Asian Pharmaceutical Industry.

January 25 - 28, 2015
Crystal Gateway Marriott - Arlington, VA

IFPAC is the essential meeting place for the latest developments in Process Analytical Technology...PAT and Quality by Design...QbD within the Pharmaceutical, Biotechnology, Generic and related industries. IFPAC is known for being a collaborative forum to exchange ideas and network through panel discussions, evening sessions, poster sessions, and the exhibition. For over 25 years IFPAC has brought together practitioners from industry, academia and government to discuss new trends in technology, standards, and controls.

IFPAC-2015 will feature comprehensive Pharmaceutical/Biotechnology tracks including the topics: Quality by Design (QbD), Process Analytical Technology (PAT), Continuous Manufacturing, Real-Time Release, Process Monitoring & Control, BioProcessing, Biologics, Contract Manufacturing/CMO/CRO, International Harmonization of QbD, Risk Assessment and Enhanced Approaches to Analytical Procedures, Continuous Process Verification/Process Validation Guidelines, QbD and PAT in the Generic Industry, Imaging, various analytical techniques including: NIR, Raman, and Mass Spec and more. An emphasis will be placed on lifecycle management & control and risk management throughout the IFPAC-2015 sessions.

IFPAC continues to attract high profile speakers from International and U.S. Regulatory Agencies, Universities/Research Institutions and Industry covering the latest research, trends, technological advances, case studies and the latest in regulatory guidance. IFPAC also offers a unique opportunity bringing together a blend of different fields to discuss common problems and solutions. Don't miss this opportunity to meet with new and existing colleagues from the pharmaceutical, biotechnology, food, generic, chemical, petrochemical and other related fields. Plus even more opportunities for networking and Q&A through roundtables and evening sessions.

IFPAC provides an opportunity to interact with other industries that have been using PAT for nearly 65 years

World NSCLC Summit
January 27-28
Colonnade Hotel in Boston, MA

Skygenix's Annual World NSCLC Summit (Non-Small Cell Lung Cancer) will bring together over 100 senior level attendees from the pharmaceutical industry to discuss the most crucial challenges in the development of targeted therapies in NSCLC.

The segment is forecast to grow from $4.9 billion to over $8.5 billion in 2023, driven by the entry of thirteen novel drugs. Over the two days the World NSCLC Summit will cover presentations on the latest updates from the NSCLC pipelines of small and large drug developers, and feature discussions around all the latest trends in personalized medicine, as pertaining to this disease area, through case studies from early discovery to commercial development. Topics Include: Antibody Drug Conjugates, Immunotherapies, Overcoming Resistance to First Line Treatment, Cancer Genomics and Companion Diagnostics.

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February 2015

Feb. 3-5, 2015
New Orleans, LA

InformEx is the only event of its kind offering participants a direct view of what is happening globally across the fine, specialty & custom chemical marketplace. The event brings together an international mix of motivated buyers and sellers of high value chemistry for 3 days of sourcing, education & networking.

19th Annual ARC Industry Forum - Industry in Transition: The Information Driven Enterprise in a Connected World
February 9 - 12, 2015
Orlando, FL

What does it mean to be information-driven? New information technologies such as Internet of Things, predictive analytics, intelligent embedded systems, network connectivity, additive manufacturing, cloud computing, mobility, and 3D visualization are beginning to disrupt and radically change the way companies do business. An information-driven enterprise leverages these new technology solutions to improve business processes, achieve agility, and sustain a competitive edge. Join us to learn how an information-driven strategy can better position you to succeed and determine how you can best approach critical technology decisions.

Forum programs include: Cyber Security, Analytics and Big Data, Connected Asset Performance, Cloud Computing, Innovations in Automation, Industrial Internet of Things, Workforce Development and Training, and Energy Optimization. For more information, please visit:

6th Patient Adherence and Advocacy Summit
February 9 - 12, 2015
The Rittenhouse Hotel, Philadelphia, PA

This summit brings together a variety of different key stakeholders to discuss how they can partner with the pharmaceutical industry to improve patient adherence. Academia shares the latest findings in adherence research; technology providers give an update on innovative tools to engage patients and assist them; advocacy groups outline patient needs and share best practices on how to raise awareness; and the industry analyzes how successful collaborations, adherence programs and effective marketing have resulted in behavioral changes.

GPhA Annual Meeting
Feb. 9-11, 2015
Miami Beach, FL

Each year, nearly 700 attendees gather to gain insight on how the nation's most critical health and regulatory issues will impact the generic industry and the consumers who benefit from access to affordable medicines.

Our meeting attracts leading speakers from around the globe who will leave attendees with a comprehensive understanding of the opportunities and challenges for the generic pharmaceutical sector in 2015. This lineup – combined with unparalleled networking opportunities – makes GPhA's Annual Meeting the generic industry event of the year.

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March 2015

ISPE GAMP® 5 Classroom Training
March 2 - 4, 2015
Phoenix Hotel Copenhagen - Copenhagen, Denmark

This three-day fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements. The course does not aim to cover detailed and highly technical aspects of software and hardware engineering, but rather gives the principles and an overview of the overall computer systems compliance process, including a scaleable and efficient system lifecycle, Quality Risk Management , updated GAMP categories, the role of the supplier, and the selection of appropriate specification and verification activities.

Calibration & Validation in GxP-Compliant Environments Seminar
March 5 2015
Vaisala - Woburn, MA

Topics & Times:
Calibration for Life Science 8:30am - 12:00pm
Temp/RH Mapping for GxP Compliance 1:30pm - 5:00pm

Pittcon 2015
March 8 - 12, 2015
Morial Convention Center - New Orleans, LA

Pittcon is the world’s largest annual conference and exposition for laboratory science. The dynamic exposition consists of nearly 1,000 exhibitors from over 30 countries displaying the latest instrumentation and equipment used by the pharmaceutical community. Learn about the latest news/trends, innovations and products in pharmaceutical manufacturing. This must attend event which gives you a unique, once a year chance to network with colleagues from around the world and talk with technical experts to get answers to your most critical questions. 

Calibration & Validation in GxP-Compliant Environments Seminar
March 12, 2015
Gaithersburg Marriott Washington Center– Gaithersburg, MD

Topics & Times:
Calibration for Life Science 8:30am - 12:00pm
Temp/RH Mapping for GxP Compliance 1:30pm - 5:00pm

PDA Annual Meeting 2015
Mar. 16-18, 2015
Las Vegas, NV

The 2015 PDA Annual Meeting offers the most concentrated education and networking opportunities with leading industry experts focused on Bio/Pharmaceutical science, manufacturing technology, quality and evolving regulations. It will provide a look into the future of manufacturing and the actions necessary today to prepare for the changes of tomorrow. Maximize the benefits of the knowledge gained at the Annual Meeting when you attend the post-conference Aging Facilities Workshop March 18-19 and PDA 2015 Annual Meeting Course Series March 19-20! Take advantage of special registration discounts when you register for all three!

March 16 - 18, 2015
Waldorf Astoria New York

The Drug, Chemical & Associated Technologies Association (DCAT) is a not-for-profit, member-supported business development association for the global pharmaceutical manufacturing industry. We are committed to providing programs, events and services that help our members expand their network of customers, suppliers and colleagues in the industry. Contact DCAT: phone: 609-208-1888; Website:

API Supply: Key Strategies for Creating Value in Early-Stage Development
March 19, 2015
Embassy Suites Airport-Waterfront - Burlingame, CA

Free presentations: 
"Supply of API for Early Development" James Henshilwood, Ph.D., Intermune
"API Continuous Process Considerations" Peter Poechlauer, Ph.D., Patheon
"How IP Decisions Can Add Value" Bernie Brown, Ph.D., J.D., Womble Carlyle Sandridge & Rice

ProMat® 2015
March 23 - 26, 2015
McCormick Place South | Chicago, IL

On March 23 – 26, 2015, MHI will host its premier manufacturing, supply chain and logistics event – ProMat®. Attending ProMat 2015 allows you to connect face-to-face with the innovative equipment and system solutions of over 800 of the industry’s leading providers in person, in action.

ProMat is the one show where you will see the latest solutions and innovations the industry has to offer and meet the leading providers face-to-face. The 300,000 square foot show floor will feature over 800 exhibitors from industry, commerce, and government. ProMat 2015 will include an Educational Conference with show-floor seminars and Keynotes. At ProMat 2015, you can also network with your peers in over 100 educational sessions as leading industry experts provide information on the latest manufacturing and supply chain trends, technologies and innovations.

If you are involved in manufacturing, distribution and the supply chain you will benefit from meeting with other professionals, at all levels, in your field on the show floor. As a manufacturing, distribution and supply chain professional, ProMat is your must-attend event in 2015. Only at ProMat can you network, learn the latest advances, and see firsthand the innovative products and services of leading solution providers. This event is only available once every two years and is a can’t-miss event for all industry professionals.

Make plans now to attend ProMat 2015 to find what’s next in manufacturing and the supply chain. Register now for free admission to the ProMat 2015 exhibits and educational conference at

Natoli Training Course
Basics of Tablet Manufacturing and Troubleshooting
March 24-26
Natoli Training Center, St. Louis, MO

The course will focus on best practices for successful tableting with a heavy emphasis on tips and tricks to avoid common manufacturing problems. Course attendees will learn the basics of tablet shapes and designs, tablet press setup & operation, tooling options and steel types, tool inspection, and tool reworking and polishing. The course includes invaluable hands-on experience with tablet manufacturing and maintenance equipment that goes beyond what is available from textbooks or webinars.

The course is designed for anyone in the tablet compression industry, including tooling technicians, tablet press operators, tablet press maintenance technicians, QC/QA personnel, research and development, and supervisors. For more information about this course, go to

Quality by Design Symposium
March 25, 2015
Leicester Tigers, UK

This event brings together academics, regulators and industrial experts to share academic research aligned to the QbD agenda as well as progress in "real life" QbD implementation. The meeting will focus on Continuous Process and Biopharmaceuticals. Speakers are from companies such as GlaxoSmithKline, Medimmune, AstraZeneca, Arlenda, Peptido GmbH and more. For detailed information, visit:

IBC Biopharmaceutical Development & Product Week
March 30-April 2, 2015
San Diego, CA

The development and production path presents many challenges. So whether it's a solution or strategy to overcome complex drug and manufacturing challenges or networking and collaboration opportunities in a unique and evolving biopharmaceutical marketplace, you and your colleagues will certainly benefit by attending BDP Week 2015.

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April 2015


Calibration & Validation in GxP-Compliant Environments Seminar
April 9 2015
Holiday Inn Elk Grove - Elk Grove, IL

Topics & Times:
Calibration for Life Science 8:30am - 12:00pm
Temp/RH Mapping for GxP Compliance 1:30pm - 5:00pm

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements
April 16, 2015
Online Event - ComplianceOnline

Why Should You Attend: Compressed air is often overlooked as a potential source of clean room and product contamination. This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system. A detailed description of a typical pharmaceutical compressed air system with its individual components will be provided. Engineering schematics will also be included. All component functions will be detailed with recommendations as to which component type is considered optimal. The four contamination sources in compressed air will be discussed. Suggestions will also be provided for preventing contamination. Finally, a compilation of all FDA/EU GMP guidelines, USP/EP and ISO air standards will be presented. Sampling and testing methodology for each of these specifications will be discussed as well.

2nd Annual Peptides Congress 2015
April 20, 2015
Novotel London West, London

Oxford Global’s 2nd Annual Peptides Congress provides the opportunity to hear key opinion leaders from the peptides industry discussing their promising research results. The conference focuses on the key areas of the peptides industry spread over 2 interactive streams: On day one our renowned speakers will explore technologies for peptide screening, synthesis and modification. Internationally esteemed experts will address new approaches for high-throughput screening, novel peptide conjugation strategies to enhance potency and half-life and activating different synthesis technologies. Presentations will explore the future opportunities in peptide design and the development of novel peptide conjugates. Day two of the congress will focus on peptide case studies covering discovery, preclinical and clinical development, therapeutic applications, peptide formulation and delivery. Esteemed peptide experts will deliver presentations on enhancing the oral bioavailability and drugability of peptides as well as updates in discovery and preclinical and clinical development. Delegates will have the opportunity to learn about recent developments involving cell-penetrating peptides, macrocycles, polypeptides and bioactive peptides. To download the agenda in full, please visit For further information on the Congress, and to inquire about available discounts, please contact Steph Punfield on or call +44 (0)1865 248455.

PDA Train-the-Trainer Week
April 20 - 23, 2015
PDA Training and Research Institute - Bethesda, MD

PDA has teamed up with industry experts to help you and your company by providing three-course training for the trainer over four days to facilitate continuing education:

Qualifying Your SMEs as Trainers (April 20)

Learn the minimum requirements necessary to develop an in-house Trainer Qualification program, focusing on identification of SMEs, organizational readiness, what belongs in a department trainer’s curriculum, first-time observation of trainers, and department trainers – employee qualification.

Learning, Knowledge Management and Impact: Moving from Theory to Practice (April 21–22)

Examines key theories that describe knowledge management and how people learn and discusses ways to apply these theories to the challenges faced in the bio/pharmaceutical industry. Topics include: knowledge acquisition and transfer, procedure writing and training, new employee on-boarding, web-based learning, and assessment and evaluation.

Designing/Presenting GXP Training Programs to Meet FDA Requirements (April 23)

Through individual and group exercise, addresses reviewing past GMP training topics, conducting a needs analysis, selecting a topic tied to facility quality objectives and FDA quality requirements, brainstorming creative approaches, developing the presentation, maximizing presentation success, evaluating training effectiveness, and audit-proofing training documentation. 

April 21 - 23, 2015
Javits Center, New York, NY

International Pharmaceutical Expo (INTERPHEX), sponsored by Parenteral Drug Association (PDA), the leading annual industry event dedicated to showcasing pharmaceutical and biopharmaceutical innovation, technology and knowledge of biopharmaceutical to safely and cost effectively process all dosage forms for life-enhancing drugs. Our events bring global pharmaceutical and biotechnology professionals together with leading suppliers through a unique combination of exhibition, education, workshops, partnering opportunities, and networking events. Visit us at

ISPE San Diego Training Series
April 27-30 2015
Hilton San Diego, Mission Valley

Learn how to improve manufacturing efficiency, maintain product quality and improve GMP compliance. Most courses leverage ISPE Guidance documents produced by pharmaceutical manufacturing industry professionals. These guides provide the practical, "real world" information needed to build on best practices to meet and exceed current regulatory requirements.

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May 2015


PDA’s Lyophilization Week
May 4-7, 2015
PDA Training and Research Institute - Bethesda, MD

PDA has designed two GSA scheduled courses to increase your knowledge on the fundamentals and validation of lyophilization technology.

Fundamentals of Lyophilization (May 4–5) This course is designed for you to develop an understanding of the basic principles and practical aspects of lyophilization technology. Selected topics include an overview of cycles and equipment, vacuum technology use for freeze drying, sublimation in primary drying, desorption during secondary drying, application of principles to product and process development, analysis of product characteristics and process scale-up to production. Upon completion of this course, you will have a working knowledge for practical application in development, production, and evaluation of lyophilized parenterals.

Validation of Lyophilization (May 6–7) This course is designed to give you an understanding of the requirements for qualification of a lyophilizer and validation of lyophilization processes. In addition, you will gain an understanding of the basic principles of lyophilization and the techniques utilized in evaluation of lyophilized materials. The course format will include lecture and discussion of principles, as well as case studies and examples.

2015 ISPE Europe Annual Conference in Frankfurt, Germany
May 4-7, 2015
Steigenberger Airport Hotel

The 2015 ISPE Europe Annual Conference – Driving Effectiveness in Pharmaceutical Operations with Integrated Quality will bring together pharmaceutical, regulatory and technology experts from around the world.

This three-and-a-half-day, must-attend, education conference will use best practice case studies to explore current technologies, regulatory requirements and will provide delegates with techniques for the evaluation and implementation of cutting-edge technologies. In-depth discussion through four tracks will cover cost-effective, flexible, sustainable manufacturing facilities design and implementation; the use of IT and advanced technology in the drug manufacturing; drug supply and inspections requirements; and drug submissions and quality by design.

ISPE Brussels Belgium Training Series
May 4-6 2015
Crown Plaza Brussels – Le Palace

Learn how to improve manufacturing efficiency, maintain product quality and improve GMP compliance. Most courses leverage ISPE Guidance documents produced by pharmaceutical manufacturing industry professionals. These guides provide the practical, "real world" information needed to build on best practices to meet and exceed current regulatory requirements.

PDA’s Recommended Practices for Manual Aseptic Processes
May 11 - 12, 2015
PDA Training and Research Institute - Bethesda, MD

Register today for this course, which will provides valuable practical insights into the technological challenges associated with designing, operating and evaluating manual aseptic processing. You will leave with an understanding of how manual and automated aseptic processes differ, and what should be addressed as you work with manual aseptic processes in your own plants. This course will provide a lab-based tutorial of suitable physical techniques, equipment use, and processing operations that can be used to address the challenges posed in the design and control of manual aseptic processing. Topics such as personnel training and qualification, design of manual aseptic processes and evaluation of manual aseptic processing process simulations will be covered. The course is based on a PDA Technical Report addressing the same subject.

PDA’s Risk Based Approach for Prevention and Management of Drug Shortages
May 13, 2015
PDA Training and Research Institute - Bethesda, MD

When you attend this PDA course, you’ll learn how to apply a proactive risk-based model at product level to identify drug shortage risks due to manufacturing and quality issues. You will practice how to develop a Drug Shortage Risk Register and a Drug Shortage Prevention and Response Plan using examples and standard templates. Learn what controls can be established in the end-to-end product value chain to address drug shortage risks in a manner that will enable them to proactively prevent drug shortages and think creatively and in a risk-based manner about other practical solutions that can be leveraged beyond conventional solutions. To ensure implementation of learned principles, you will be provided with a practical risk-based triage tool and templates they can use within their companies to proactively identify and manage drug shortage risks. Register today!

Pharma Pro & Pack Expo 2015
May 13 - 15, 2015
Mumbai Exhibition Centre, Mumbai INDIA

PHARMA Pro & Pack Expo 2015 offers you an EXCELLENT opportunity to expand your business in India and international pharma industry. You can Join the industry majors from India and across the world at the Technology Show, This exhibition is a Point of contact to meet your clients & prospective customers at one place. You can Update, Revive and Explore your Trade Contacts and Expand your Business to new customers locally & internationally. It is an excellent opportunity for Technology Exchange & Marketing Tie-up.

ISPE St. Louis Training Series
May 18-21 2015
St. Louis Union Station Hotel

Learn how to improve manufacturing efficiency, maintain product quality and improve GMP compliance. Most courses leverage ISPE Guidance documents produced by pharmaceutical manufacturing industry professionals. These guides provide the practical, "real world" information needed to build on best practices to meet and exceed current regulatory requirements.

2015 PDA Pharmaceutical Packaging Conference
May 18 - 19, 2015
Four Seasons Hotel Baltimore - Baltimore, MD

The state of pharmaceutical packaging is rapidly evolving, and, along with these advancements, come new challenges. The 2015 PDA Pharmaceutical Packaging Conference will address the dynamics of selecting and qualifying packaging systems throughout the pharmaceutical product lifecycle, ensuring safe and effective delivery of medicines to patients. Learn more at

2015 PDA Pharmaceutical Packaging Course Series
May 18 - 19, 2015
Four Seasons Hotel Baltimore - Baltimore, MD

The selection of appropriate packaging components and systems throughout the manufacture, storage and distribution channels is central to ensuring the pharmaceutical product is protected until delivered to the end user. The 2015 PDA Pharmaceutical Packaging Course Series two courses addressing current industry challenges— selecting appropriate packaging components, and managing product quality and risk. For more information and to register, visit

2015 PDA Drug Delivery Combination Products Workshop
May 20 - 21, 2015
Four Seasons Hotel Baltimore - Baltimore, MD

Register today for the 2015 PDA Drug Delivery Combination Products Workshop! This workshop will provide real-life experiences from representatives from leading pharmaceutical and biotech companies and updates and recommendations from the U.S. FDA, arming you with implementable solutions to today’s challenges in the development, approval and manufacture of combination products! Learn more at Following the workshop, on May 22, PDA will hold a one-day training course, Technical Development of Prefilled Syringes, Autoinjectors and Injection Pens, focusing on strategy and tactics for developing these and related drug delivery systems. Visit today!

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June 2015


2015 ISPE/FDA/PQRI Quality Manufacturing Conference
June 1-3 2015
The Mayflower Renaissance

Quality, Regulatory and Manufacturing, The most talked about conference in the industry! Honorary Chairs Janet Woodcock, FDA, invited, and Juan Andres, Novartis AG invite you to join them as the industry addresses current challenges impacting your company. ISPE and PQRI will host the pharmaceutical industry and the FDA for an open dialogue on the most critical changes to policy and regulations of manufacturing, facilities, quality systems, Chemistry, Manufacturing, and Controls (CMC) and Lifecycle management. The 2015 program includes three dynamic education tracks, regulatory panels, networking receptions and an exhibit hall featuring more than 40 exhibitors.

2015 PDA Aseptic Processing – Sterilization Conference
The Evolution of Contemporary Practice Driven by Science and Risk Management
Exhibition: June 9-10, 2015
Courses: June 11-12, 2015
Loews Coronado Bay Resort | San Diego, CA

The 2015 PDA Aseptic Processing – Sterilization Conference will provide unrivaled access to top industry and regulatory professionals speaking on current issues related to aseptic processing, such as updates to PDA’s Points to Consider for Aseptic Processing, USP < 797> and the FDA’s Draft Guidance regarding Aseptic Processing. Register today! Immediately following the conference on June 11-12, PDA will host four education courses to expand your learning on everything from process simulation testing to parametric release. For more information and to register for the 2015 PDA Aseptic Processing−Sterilization Course Series, visit

Sensors Expo & Conference
Conference & Expo: June 10-11, 2015
Pre-Conference Symposia: June 9, 2015
Long Beach Convention Center - Long Beach, CA

Sensing Technologies Driving Tomorrow’s Solutions

Sensors Expo & Conference is the only industry event in North America exclusively focused on sensors and sensor-integrated systems. Celebrating its 30th Anniversary this year, Sensors brings years of technical innovation and thought leadership to engineers involved in the development and deployment of sensors and sensing systems. The 3-day program explores cutting-edge trends and applications including Energy Harvesting, IoT, Measurement & Detection, MEMS, Optics, Wearables, and Wireless, in an information-packed Conference Program and reflects those trends throughout the Exhibit Floor with new products, technology pavilions, demos, and a showcase of 200+ of the latest sensors on display.

Join us at the industry’s premier gathering of engineers to find the solutions for your present challenges while exploring sensing technologies that are driving tomorrow’s solutions.

Special offer for subscribers to attend Sensors 2015: Use code PM50 for $50 off Gold & Main Conference Passes or a FREE Expo Hall Pass in advance. Visit to register today and for the latest information on the 2015 event.

DIA 2015 Annual Meeting
June 14 - 18, 2015
Washington, D.C.

The DIA 2015 51st Annual Meeting brings together a global community of life sciences professionals at all levels and across all disciplines all with a common goal to foster innovation that will lead to the development of safe and effective medical products and therapies to patients. The DIA Annual Meeting provides the best opportunity to meet with people from around the world, share your views and knowledge, network, and build new relationships. Contact Drug Information Association (DIA): Phone: 215-442-6100; Website:

BIO International Convention 2015
June 15-18, 2015
Philadelphia, PA

For 2015, the BIO International Convention is headed to the heart of the U.S. biopharma industry. In close proximity to New York's financial markets and Washington, D.C.'s regulatory center, the Philadelphia Metropolitan Area is home to more than 1,200 companies, ranging from the biopharma industry's largest multinational companies to its fastest growing firms. The region's vast array of leading universities and research institutions fosters a collaborative environment. In the past 10 years alone, the region has drawn nearly $4 billion in venture capital funding (according to the Jones Lang LaSalle Life Sciences Cluster Report 2012).

2015 PDA Single Use Systems Workshop
Harmonizing Best Practice Recommendations Connecting Manufacturers, Suppliers and Global Health Authorities
Exhibition: June 23-24, 2015
Courses: June 25-26, 2015
Bethesda North Marriott Hotel and Conference Center | Bethesda, MD

The 2015 Single Use Systems Workshop will focus on a critical element in the successful implementation of single use systems (SUS) — a transparent partnership between SUS suppliers and pharmaceutical manufacturers, encouraging an open science- and risk-based dialogue. This valuable workshop will present perspectives of end users, manufacturers, suppliers and industry enablers, resulting in a balanced, well vetted, consensus viewpoint on important industry topics.

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September 2015


2015 PDA/FDA Joint Regulatory Conference
Mission Possible: Patient-Focused Manufacturing, Quality and Regulatory Solutions
Exhibition: September 28-29, 2015
Post workshop: September 30-October 1, 2015
Courses: October 1-2, 2015
Renaissance Washington, DC Downtown Hotel | Washington, DC

Join us at the 2015 PDA/FDA Joint Regulatory Conference and take the unique opportunity to dialogue with FDA representatives and industry experts face-to-face to discover firsthand how to comply with regulatory global strategies and industry strategic initiatives from leaders and advocates who are shaping the global regulatory compliance landscape and take home best practices for compliance. Ask questions of the experts, influence direction and take home innovative and pragmatic solutions that will drive compliance in your business. Register today! You won’t find this level of direct information exchange with FDA at any other conference.

Pharma Expo/Pack Expo Las Vegas
Sep. 28-30, 2015
Las Vegas, NV

PACK EXPO Las Vegas will be world’s largest packaging and processing event in 2015. The event will bring together decision makers from a wide array of industries and all across the supply chain. Combined with Pharma EXPO, you can expect to see:

• 30,000+ attendees from 40+ vertical markets
• 5,000 international buyers from 130 countries
• Over 1,800 exhibiting companies
• 800,000 net square feet of exhibit space

ISPE Barcelona, Spain Training Series
September 28-30 2015
The Hilton Barcelona

Learn how to improve manufacturing efficiency, maintain product quality and improve GMP compliance. Most courses leverage ISPE Guidance documents produced by pharmaceutical manufacturing industry professionals. These guides provide the practical, "real world" information needed to build on best practices to meet and exceed current regulatory requirements.

September 29 - October 1, 2015
Hilton Hotel - Algiers

The 4th International Exhibition of the Pharmaceutical Industry Suppliers in North Africa will gather + 170 international Exhibitors of Pharma Ingredients, Machinery, Packaging, Cleanroom, Laboratory Equipments to participate to the booming growth of pharmaceutical manufacturing capacities in Algeria, Morocco & Tunisia.

2015 PDA Manufacturing Science Workshop
Advancing Pharmaceutical Manufacturing with Continuous Manufacturing and Efficient Implementation of Post Approval Change
September 30-October 1, 2015
Renaissance Washington, DC Downtown Hotel | Washington, DC

The 2015 PDA Manufacturing Science Workshop will explore examples of continuous manufacturing from other industries, as well as examples of applications in pharmaceutical manufacturing. Through the interactive participation of attendees, this workshop will explore the barriers for implementation, challenges in adoption of these processes, and regulatory changes that may be required. Upon completion of the workshop, you will have learned how to collaborate firsthand with a diverse group of industry and regulatory representatives on effective ways to review modernization needs, develop action plans and implement change! Register today!

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October 2015


2015 PDA Regulatory Course Series
October 1 -2, 2015
Renaissance Washington, DC Downtown Hotel | Washington, DC

What do you get when you cross in-depth training, six experts and two days? PDA’s Regulatory Conference Course Series! In two days, you and your colleagues will learn more about risk based product development, quality metrics, root cause investigations, process validation and Verification as well as CMC regulatory requirements! Register today!

PDA 10th Annual Global Conference on Pharmaceutical Microbiology
Promoting Excellence: Past Lessons, Present Solutions and Future Visions
Exhibition: October 19-20, 2015
Courses: October 22-23, 2015
Bethesda North Marriott Hotel and Conference Center | Bethesda, MD

The PDA 10th Annual Global Conference on Pharmaceutical Microbiology will address pressing challenges to product quality and infection control in today’s global market. The comprehensive program agenda will include presentations from regulatory and industry experts from around the world who will share recent case studies and current trends in the field of pharmaceutical microbiology. Register today! Following the conference, on October 22-23, PDA will be hosting three courses to complement the knowledge you have acquired at the conference!

ISPE Boston, MA Training Series
October 19-23 2015
The Inn at Longwood Medical

Learn how to improve manufacturing efficiency, maintain product quality and improve GMP compliance. Most courses leverage ISPE Guidance documents produced by pharmaceutical manufacturing industry professionals. These guides provide the practical, "real world" information needed to build on best practices to meet and exceed current regulatory requirements.

2015 PDA Visual Inspection Forum
Exhibition: October 26-27, 2015
Courses: October 28-29, 2015
Bethesda North Marriott Hotel and Conference Center | Bethesda, MD

The 2015 Visual Inspection Forum will provide a forum of presentations and discussions on new developments in the field of visual inspection, including a basic understanding of the sampling and inspection process, special aspects of biotech products, practical aspects of manual and automated methods and the regulatory and compendial requirements that govern them. See the latest in commercial inspection hardware and discuss production needs with key suppliers of inspection systems and services on-site during the exhibition days.

Pharmaprocess Forum
October 27-28 2015
Fira Montjuic - Barcelona

PHARMAPROCESS INNOVATION FORUM IN PHARMACEUTICAL PROCESS Barcelona (Spain) will host the second edition of PharmaProcess forum. PharmaProcess is the international benchmark for professionals devoted to optimize and maximize pharmaceutical processes efficiency. Meet the experts and technicians who will shape the future of pharma manufacturing by facing today's challenges! PharmaProcess will provide professionals with improved responsiveness to market innovations in the following areas: Development and Regulatory, Operations and Business Development. Register before May 31st and save 200€ in your congress subscription.

IBC Bioprocess International Conference & Exhibition (BPI)
October 26-29, 2015
Hynes Convention Center
Boston, MA

The biopharmaceutical industry’s premier event. It is the one place where you know you will meet with the key players in the field. From high-level strategy to nuts and bolts technical case studies, the program digs deep into important areas where regulatory, technical and market forces are changing the field. Whether you work with mAbs, recombinant proteins, vaccines, or other types of biologics – at a large or small company – here you will find presentations and discussions which will answer your specific information requirements.

AAPS Annual Meeting & Exposition
Oct. 25-29, 2015
Orlando, FL

The AAPS Annual Meeting and Exposition, a premier event in the pharmaceutical sciences industry, draws attendees from around the world who are involved in all phases of drug development. The AAPS Annual Meeting and Exposition showcases late-breaking research, validates scientific methodology and reveals the latest technology, services and supplies. Speakers include scientists from the Food and Drug Administration, US National Institutes of Health, leading pharmaceutical companies and academia.

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November 2015

Global Pharma Manufacturing Summit
Nov 2 - 3, 2015
Boston, MA

With the pharmaceutical industry at a critical point, you are faced with the harsh and uncertain reality as to whether or not your manufacturing facilities will survive. The key to success lies in coming together, joining forces, spreading the ideas and sharing the winning strategies.

Celebrating 10 years of the Summit, this year you will learn how to:

  • Build flexibility into your business model for long term survival in the small molecule market
  • Create the smart facilities of the future in the transition towards continuous manufacturing
  • Enhance supply chain agility by increasing visibility throughout your manufacturing operations
  • Guarantee inspection readiness with tailored interactive problem solving workshops
  • Revolutionize your production and supply life cycle by adopting leading technology innovations

Visit for more information.

Biosimilars Conference 2015
Nov 4, 2015
De Vere Venues, London

This 2-day conference is the third of its kind. It will provide an update on the current status for biosimilars in EU and internationally with focus on both regulatory and scientific challenges as well as market access and experiences. Patients and physicians approach to use of biosimilars will be part of the conference scope including a discussion on biosimilars adoption into current treatment guidelines in EU. The conference will consist of plenary lectures followed by interactive panel discussions providing participants an opportunity to bring forward their own experience and share their thoughts and ideas with the experts.

AIChE Annual Meeting
Nov. 8-12, 2015
Salt Lake City, UT

The AIChE Annual Meeting is the premier educational forum for chemical engineers interested in innovation and professional growth. Academic and industry experts will cover wide range of topics relevant to cutting-edge research, new technologies, and emerging growth areas in chemical engineering.

ISPE Annual Meeting
Nov. 8-12, 2015
Philadelphia, PA

The new paradigm for manufacturing excellence. Contribute to robust supply networks; advance quality of production; prevent drug shortages.

ISPE Philadelphia, PA Training Series
November 9-10 2015
Philadelphia Marriott Downtown

Learn how to improve manufacturing efficiency, maintain product quality and improve GMP compliance. Most courses leverage ISPE Guidance documents produced by pharmaceutical manufacturing industry professionals. These guides provide the practical, "real world" information needed to build on best practices to meet and exceed current regulatory requirements.

International Water Conference® (IWC)
Nov. 15-19, 2015
Orlando, FL

The International Water Conference® (IWC) is a strong educational conference, founded with an emphasis on commercial free discussions on technology. The IWC presents the latest in scientific advances and practical applications in this field, cutting across a wide range of industries, technologies and functional areas. As the preeminent international technical forum in the field, the IWC brings together end users, researchers, practicing engineers, managers, educators, suppliers and contractors. It is dedicated to advancing new developments in the treatment, use and reuse of water for industrial and other engineering purposes. Attendeescome to learn unbiased details about the latest applications available in the industry, get educated on current technology and hold wide ranging discussions with their peers active in water treatment.

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December 2015


ISPE Tampa, FL Training Series
December 7-10 2015
The Holiday Inn Tampa Westshore

Learn how to improve manufacturing efficiency, maintain product quality and improve GMP compliance. Most courses leverage ISPE Guidance documents produced by pharmaceutical manufacturing industry professionals. These guides provide the practical, "real world" information needed to build on best practices to meet and exceed current regulatory requirements.

December 15 - 17, 2015
Abu Dhabi

The 1st Middle-East Pharma Technology Expo & Conference will gather + 100 international Exhibitors of Pharma Ingredients, Machinery, Packaging, Cleanroom, Laboratory Equipments in Abu Dhabi to participate to the booming growth of pharmaceutical manufacturing capacities of the Gulf & Middle-East Countries. + Finished product B2B for Partnering opportunities. Do not miss this Event!

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