Global Expansion Shapes Drug Oversight; Wockhardt Cited by FDA for QC Failures

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Using Engineered Particles in Capsules for Rapid-to-Clinic Dry Powder Inhalation Applications
Wednesday June 25, 2014 at 11:00 AM EDT
Sponsored by: Capsugel

Best Practices to Overcome Softgel Coating Challenges
Wednesday July 9, 2014 at 11:00 AM EDT
Sponsored by: BASF

Meeting Regulatory and Technical Requirements for Organic Impurity Analysis
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Sponsored by: SGS Life Science Services

Optimizing Microbial Quality Control Testing
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Sponsored by: Rapid Micro Biosystems

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Validation Week Puerto Rico
June 17-18, 2014
San Juan, Puerto Rico

Product Complaints for Bio/Pharmaceuticals and Medical Devices
June 17-19, 2014
Washington, DC

Bio International Convention
June 23-26, 2014
San Diego, CA

DCAT’s Sharp Sourcing 2014
July 10, 2014
New Brunswick, NJ

June 12, 2014

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Global Expansion Shapes Drug Oversight
Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.

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Advances in Controlled-Release Drug Delivery
Industry experts share their perspectives on key advances in controlled-release drug delivery and future innovations in this arena.

Bureaucratic Roadblocks Threaten Biopharma Growth
Protecting intellectual property rights is vital to biopharmaceutical innovation.

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EMA Reinstates GMP Certificate for Ranbaxy's Toansa Facility
Despite deficiencies, EMA reinstates GMP certificate for Ranbaxy's Toansa facility, citing no threat to public health.

EMA Changes Guideline on Drug Name Acceptability
EMA publishes revised guideline on the acceptability of names for drugs.

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The Risk and Compliance Paradigm: Risk Management's Impact on QMS
Risk Management is everywhere, and is not some lofty strategic element that is limited to top floor suits making enterprise-wide decisions. Risk Management is becoming an integral part of the compliance process. There are many ways to look at Risk, and each industry has developed different risk based tools to suit their specific business needs.

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Wockhardt Cited by FDA for Quality Control Failures
FDA issues a Form 483 to Wockhardt for quality issues at Morton Grove, IL facility.

APIC Publishes New Industry Best Practices Documents
APIC provides guidance on cleaning validation in API plants and how to implement GDP for APIs.

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Life Cycle Management Opportunities in Softgel Technologies
Live webcast: Wednesday, May 21, 2014 at 8:00am PDT/ 10:00am CDT/11:00am EDT
To Register Free:

www.pharmtech.com/opportunities

Cellectis Enters Agreement With CELLforCURE
Cellectis enters an agreement with CELLforCURE for cGMP clinical manufacturing of allogeneic T-cells.

Merck to Acquire Idenix
Merck acquires Idenix Pharmaceuticals for $3.85 billion.

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USP Accepts Welcomes New Partners to “Fight the Fakes” Campaign
Eleven new organizations join the global “Fight the Fakes” campaign.

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Delivering Biologics with a difference
Live Webinar: Thursday, June 5, 2014 at 11:00 am EDT
To Register Free:

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Bayer Extends CEO Contract
Bayer extends its CEO contract with Marijn Dekkers until 2016.

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Lyophilization Cycle Design and Scale Up – Practical Methodologies for Developing Cycles
On Demand Webcast
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Malvern Instruments to Acquire MicroCal
Malvern Instruments will acquire the MicroCal business from GE Healthcare Life Sciences.

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Best Practices to Overcome Softgel Coating Challenges
On Demand Webcast
To Register Free:

www.pharmtech.com/coating

Roche Acquires Genia Technologies
Genia's DNA-sequencing platform will strengthen Roche's pipeline.

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Using Engineered Particles in Capsules for Rapid-to-Clinic Dry Powder Inhalation Applications
Live Webinar: Wednesday June 25, 2014 at 11:00 AM EDT
To Register Free:

www.pharmtech.com/drypowder

PharmTech editors seek your opinion on business trends in contract manufacturing and research. Enter to win a $100 gift card.

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Bioprocessing and Sterile Manufacturing
View technical articles on the development and manufacturing of parenteral and biologic drugs, including continuous manufacturing, monitoring, sterilization procedures, modular manufacturing, and more.

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Pharmaceutical Technology presents its Process Analytical Technology resource guide combo
A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects. ... Click here

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