About This Event

cGMP Raw Material Requirements Seminar

“This highly interactive two day seminar on raw material requirements in a cGMP environment will:

Consider FDA, Health Canada, ICH, USP and EP requirements.
Examine a variety of the issues surrounding raw materials to include what materials should be tested and to what extent during Phase 1, 2, 3 and commercial production.
Cover testing requirements during each Phase (Phase appropriate), to include microbial and endotoxin, and what may be optional (regulatory risk) until the product moves to its next Phase.
Determine what options exist – even within a Phase 2 or Phase 3 testing framework.
Discuss compendial vs. non-compendial testing and how to respond when no method is available.
Discuss how a 90 percent vs. a 90.0 percent minimum purity analysis can delay initiation of testing.
Explore the number of lots required for testing before reduced testing might occur and why some companies don’t accept this route.
Review the use of individual samples vs. composite samples for testing.
Explore ASQ testing to include how to choose attributes and sample size”
“This highly interactive two day seminar on raw material requirements in a cGMP environment will:

About This Event

Quality Control Laboratory Compliance Seminar

FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries – pharmaceuticals, biologics, medical devices, as well as foods and cosmetics – as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals.
FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries – pharmaceuticals, biologics, medical devices, as well as foods and cosmetics – as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals.
FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries – pharmaceuticals, biologics, medical devices, as well as foods and cosmetics – as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals.
FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries – pharmaceuticals, biologics, medical devices, as well as foods and cosmetics – as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals.
FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries – pharmaceuticals, biologics, medical devices, as well as foods and cosmetics – as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals.

About This Event

eCTD Submissions Seminar

“The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD – Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.

This two day workshop will provide you with an in-depth review of the content and format requirements of the CTD/eCTD. Hands-on activities will include organizing specific study reports and other documents into the CTD, using tools for the project management of the CTD preparation, and pre-publishing an eCTD.”
“The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD – Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.

About This Event

Phase I Clinical Trial – GMP Expectations: Seminar

Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. It is important to implement quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects.
Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. It is important to implement quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects.
Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. It is important to implement quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects.
Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. It is important to implement quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects.

About This Event

Water System Monitoring and Microbial Control Seminar

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, since this training is for everyone involved with water systems, from the lab to utility room operations. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential for the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system control and monitoring consists of a set of rules that often don’t work or result in erroneous monitoring data and can cause everything from very costly and unnecessary system downtime to patient injury and product recalls.
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, since this training is for everyone involved with water systems, from the lab to utility room operations. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential for the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system control and monitoring consists of a set of rules that often don’t work or result in erroneous monitoring data and can cause everything from very costly and unnecessary system downtime to patient injury and product recalls.
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, since this training is for everyone involved with water systems, from the lab to utility room operations. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential for the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system control and monitoring consists of a set of rules that often don’t work or result in erroneous monitoring data and can cause everything from very costly and unnecessary system downtime to patient injury and product recalls.

About This Event

International Pediatric Critical Care Conference of India – IPCCI 2018

It is our great pleasure to invite you to participate in the 1st International Pediatric Critical Care Conference of India (IPCCI-2018) which will be held from October 20th-23rd, 2018 at HICC, Hyderabad.

This innovative conference will include presentations and discussions on promoting, learning and collaboration for the care we provide to children with critical illness and their families.

National and International domain experts from across the globe will lead academic deliberations and represent their point of views.

We humbly invite to participate in this great effort by becoming the sponsors for the conference in various categories.

Industry support is vital to the success of this conference and demonstrates your commitment to improving patient care.
It is our great pleasure to invite you to participate in the 1st International Pediatric Critical Care Conference of India (IPCCI-2018) which will be held from October 20th-23rd, 2018 at HICC, Hyderabad.

This innovative conference will include presentations and discussions on promoting, learning and collaboration for the care we provide to children with critical illness and their families.

National and International domain experts from across the globe will lead academic deliberations and represent their point of views.

We humbly invite to participate in this great effort by becoming the sponsors for the conference in various categories.

This innovative conference will include presentations and discussions on promoting, learning and collaboration for the care we provide to children with critical illness and their families.

National and International domain experts from across the globe will lead academic deliberations and represent their point of views.

We humbly invite to participate in this great effort by becoming the sponsors for the conference in various categories.

Industry support is vital to the success of this conference and demonstrates your commitment to improving patient care.

About This Event

BioProcess International Conference & Exhibition

“TWO NEW CONFERENCE TRACKS
Speed from Gene to Market
Bioprocessing 4.0 – The Path to Smart Manufacturing

FIVE PRE-CONFERENCE SYMPOSIA
Viral Clearance
Process Intensification
Cell Line Development
PAT and Advanced Process Control
Continuous Processing

KEY UPDATES FROM BPOG
Technology Roadmap
Drug Product Robustness Studies
Real-Time Release
Disposables 5-Year Plan”
“TWO NEW CONFERENCE TRACKS
Speed from Gene to Market
Bioprocessing 4.0 – The Path to Smart Manufacturing

FIVE PRE-CONFERENCE SYMPOSIA
Viral Clearance
Process Intensification
Cell Line Development
PAT and Advanced Process Control
Continuous Processing

KEY UPDATES FROM BPOG
Technology Roadmap
Drug Product Robustness Studies
Real-Time Release
Disposables 5-Year Plan””TWO NEW CONFERENCE TRACKS
Speed from Gene to Market
Bioprocessing 4.0 – The Path to Smart Manufacturing

FIVE PRE-CONFERENCE SYMPOSIA
Viral Clearance
Process Intensification
Cell Line Development
PAT and Advanced Process Control
Continuous Processing

KEY UPDATES FROM BPOG
Technology Roadmap
Drug Product Robustness Studies
Real-Time Release
Disposables 5-Year Plan”

About This Event

ECSACON CONFERENCE, SEPT 2018

“a) Quality and affordability of Maternal, New-‐born and Child Health Services

b) Increasing access to Health Care including GBV services and SRHR among the Youth

c) Nursing and Midwifery Workforce Development to achieve HRH2030 Agenda

d) Innovations in preparingcompetent, skilled and motivated Nurses & Midwives