Calendar

Mar
25
Mon
3rd European Conference on Pharmaceutics: Bringing science into pharmaceutical practice @ Bologna Congressi
Mar 25 – Mar 26 all-day
3rd European Conference on Pharmaceutics: Bringing science into pharmaceutical practice @ Bologna Congressi

www.bolognacongressi.it

Mar
26
Tue
Applied Statistics, with Emphasis on Verification, Validation, and Risk Management @ Homewood Suites by Hilton Houston-Kingwood Parc
Mar 26 – Mar 27 all-day
Applied Statistics, with Emphasis on Verification, Validation, and Risk Management @ Homewood Suites by Hilton Houston-Kingwood Parc

The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:

  • ISO standards and FDA/MDD regulations regarding the use of statistics.
  • Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality.
  • Statistical Process Control
  • Statistical methods for Design Verification
  • Statistical methods for Product/Process Qualification
  • Metrology: QC Sampling Plans the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications
  • How to craft “statistically valid conclusion statements” (e.g., for reports).com/GCPanel
Apr
4
Thu
Tougher Import Rules for FDA Imports in 2019 @ Courtyard Arlington Crystal City/Reagan National Airport
Apr 4 – Apr 5 all-day
Tougher Import Rules for FDA Imports in 2019 @ Courtyard Arlington Crystal City/Reagan National Airport

FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Other factors can derail the expectation of a seamless import entry process. The course covers detailed information about the roles and responsibilities of the various parties involved with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA’s thinking, negotiate with the FDA and offer anecdotal examples of FDA’s import program curiosities.

Apr
16
Tue
Seminar on Phase I GMPs @ DoubleTree by Hilton Philadelphia Airport
Apr 16 – Apr 17 all-day
Seminar on Phase I GMPs @ DoubleTree by Hilton Philadelphia Airport

Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.
This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.

Apr
18
Thu
Death by CAPA – Does your CAPA Program need a CAPA? @ Embassy Suites Boston Logan Airport
Apr 18 – Apr 19 all-day
Death by CAPA - Does your CAPA Program need a CAPA? @ Embassy Suites Boston Logan Airport

This 2-day seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this seminar is for you.
We’ll discuss regulatory requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. We’ll discuss best practices so you can start off on the right foot and always be prepared for an inspection.
This seminar will provide detailed lectures on all elements of a CAPA program and how they connect to other parts of your Quality Management System. You will learn how to create a CAPA program that results in improved product quality, reduction in compliance issues, and ultimately leads to improved business success.

HIPAA 2019 – What’s new? @ Hyatt Place Miami Airport East
Apr 18 – Apr 19 all-day
HIPAA 2019 - What's new? @ Hyatt Place Miami Airport East

This two-day seminar will get into the fine details of what we need to do and how to do it.
We will go point by point through the entire HIPAA Security Rule and uncover simple methods to comply and create policy.
The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do’s and don’ts with HIPAA – I want to add clarity for compliance officers
It will also address major changes under the Omnibus Rule and any other applicable updates for 2018.

Apr
23
Tue
The A to Z’s of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems @ DoubleTree by Hilton Philadelphia Airport
Apr 23 – Apr 24 all-day
The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems @ DoubleTree by Hilton Philadelphia Airport

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don’t work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn’t recur.

Apr
25
Thu
Applied Statistics for FDA Process Validation 2019 @ WILL BE ANNOUNCED SOON
Apr 25 – Apr 26 all-day
Applied Statistics for FDA Process Validation 2019 @ WILL BE ANNOUNCED SOON

In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, “”…the collection and evaluation of data, from the process design stage through commercial production..” The guidance further delineates the ‘process design stage through commercial production’ into three distinct stages of the product LifeCycle.

Apr
30
Tue
Making Pharmaceuticals 2019 @ Ricoh Arena
Apr 30 – May 1 all-day
Making Pharmaceuticals 2019 @ Ricoh Arena

Making Pharmaceuticals will host over 2,000 visiting pharma professionals over two days, and 200+ exhibitors from across Europe who gather at the event to meet, network, generate business and take advantage of more than 90 free to attend pharmaceutical conference sessions.

May
6
Mon
Excipient World Conference & Expo @ Gaylord National Resort & Convention Center
May 6 – May 8 all-day
Excipient World Conference & Expo @ Gaylord National Resort & Convention Center

Excipient World is the leading education, networking and sourcing resource for the $6+ billion and growing global excipient market. Excipient World is the ONLY U.S. event focused exclusively on excipients, showcasing formulation and delivery system advances, regulatory and compliance initiatives, and innovative product applications for pharmaceutical, biologic, veterinary medicine, and medical device / combination and emerging sector manufacturers that rely on excipients.

Excipient World’s mission is to educate all excipient user manufacturers, including drug, biologics, veterinary medicine, medical device / combination product and emerging sectors, on cutting-edge scientific developments, formulation and technology advancements, quality production and the safe use of excipients, as well as regulatory mandates so they can better address the ever-changing global marketplace, while bringing buyers and suppliers together to power worldwide excipient sales and new drug and product innovations.

Drug Delivery West @ Marines' Memorial Club & Hotel
May 6 – May 7 all-day
Drug Delivery West @ Marines' Memorial Club & Hotel

The 2nd annual Drug Delivery West (DDW) Summit provides a west coast venue for biotech, pharma and drug delivery companies to address scientific and business solutions for the best routes of delivery across different therapeutic areas with an emphasis on emerging technologies and to prepare for the future of R&D and clinical care.

Jun
3
Mon
22nd Microencapsulation Industrial Convention @ 22nd Microencapsulation Industrial Convention
Jun 3 @ 9:00 – Jun 6 @ 12:40
22nd Microencapsulation Industrial Convention @ 22nd Microencapsulation Industrial Convention

> 13 Presentations from experts
Lectures from leading experts will cover a large scope of the encapsulation field. Selection mixes senior scientists with high level of encapsulation processes understanding, together with experienced business practitioners of well established practical applications.
> Up to 18 B2B Meetings
Since 1996, BRG has developed tools for optimizing the B2B meeting organisation. Based on your own pre-selection among the list of participants, we optimize your agenda with up to 18 B2B appointments. Coffee-breaks, exhibition and lunch times will give you additional networking opportunities to establish new contacts and find new partners.
> Showcase with 20 Exhibitors
A broad state-of-the-art showcase presenting R & D services, Equipment & Tools, Material & Chemicals, Established Techniques in the realm of microencapsulation. Meet your future suppliers of equipments, services and production.

Jun
24
Mon
3rd World Drug Delivery and Formulations Summit @ Yet to Confirm
Jun 24 – Jun 25 all-day
3rd World Drug Delivery and Formulations Summit @ Yet to Confirm

On behalf of PULSUS Conferences, we announce “3rd World Drug Delivery and Formulations Summit” which will be held from June 24-25, 2019 at Rome, Italy The conference will be organized around the theme “Endorse the endeavour for modern therapeutic era in Drug Delivery System’’. Drug Delivery Summit 2019 is mainly focuses on future research in drug delivery systems and pharmaceutical formulations.

Jul
5
Fri
2nd International Conference & Exhibition on Pharmaceutics & Advanced Drug Delivery Systems @ Holiday Inn Paris – Marne La Vallée
Jul 5 @ 9:00 – Jul 6 @ 18:00
2nd International Conference & Exhibition on Pharmaceutics & Advanced Drug Delivery Systems @ Holiday Inn Paris – Marne La Vallée

Mail: [email protected]
Event website: http://pharmaceutical.alliedacademies.com/

It is a great pleasure to invite you all to the 2nd International Conference and Exhibition on Pharmaceutics & Advanced Drug Delivery Systems going to be held during July 05-06, 2019 at Paris, France. The conference will be a gathering of Researchers, Scientists, Pharmacists, Pharmacologists, Healthcare Professionals, Academicians, Industrialists and Students from across the Globe. It is organized to enhance and exchange the knowledge on cutting-edge technologies, research and development, New therapeutics, and challenges in the field of pharmaceutical sciences and drug delivery. And the main theme of the conference is Exploring the Cutting Edge & Futuristic Technologies in Pharmaceutical Sciences and Drug Delivery Systems.

2nd World Pharma Congress @ Holiday Inn Paris
Jul 5 @ 9:00 – Jul 6 @ 18:00
2nd World Pharma Congress @ Holiday Inn Paris

It is a great pleasure to invite you all to the 2nd International Conference and Exhibition on Pharmaceutics & Advanced Drug Delivery Systems going to be held during July 05-06, 2019 at Paris, France. The conference will be a gathering of Researchers, Scientists, Pharmacists, Pharmacologists, Healthcare Professionals, Academicians, Industrialists and Students from across the Globe. It is organized to enhance and exchange the knowledge on cutting-edge technologies, research and development, New therapeutics, and challenges in the field of pharmaceutical sciences and drug delivery. And the main theme of the conference is Exploring the Cutting Edge & Futuristic Technologies in Pharmaceutical Sciences and Drug Delivery Systems.

Aug
27
Tue
26th International Conference on Bioencapsulation @ 26th International Conference on Bioencapsulation
Aug 27 – Aug 29 all-day
26th International Conference on Bioencapsulation @ 26th International Conference on Bioencapsulation

This event aims to promote exchanges between researchers from both public and industrial organisations on the latest advances in microencapsulation. Previous conferences brought together 120 to 150 participants, presenting 40 oral contributions and up to 80 posters.
> Who should attend ?
Any industrial, researcher and master or PhD student involved in microencapsulation or looking for information regarding its applications.

Sep
9
Mon
6th International Symposium on Phospholipids in Pharmaceutical Research @ Chester Hotel, Heidelberg
Sep 9 – Sep 10 all-day
6th International Symposium on Phospholipids in Pharmaceutical Research @ Chester Hotel, Heidelberg

The Phospholipid Research Center celebrates the 6th International Symposium on Phospholipids in Pharmaceutical Research on September 9 – 10, 2019 in Heidelberg, Germany. In accordance to our vision “Connecting the World of Phospholipids”, we focus this year mainly on stimulating discussions between academia and industry. Phospholipids have unique properties and benefits in pharmaceutical applications, which means, that exciting presentations, conversations and awards can be expected.

Sep
18
Wed
Making Pharmaceuticals Milano @ UNAHOTELS Expo Fiera Milano
Sep 18 – Sep 19 all-day
Making Pharmaceuticals Milano @ UNAHOTELS Expo Fiera Milano

Making Pharmaceuticals Milano, che avrà luogo il 18-19 settembre 2019 all’Atahotel Expo Fiera Milano, è l’evento principale per creare occasioni di business con centinaia di professionisti del settore farmaceutico mirato al mercato italiano.
Cogli la tua occasione di ottenere soluzioni e risposte, e di fornire prodotti e servizi necessari per il settore farmaceutico e dei dispositivi medici.