Sachs Seminar Invitation - BNL Sciences Seminar.pdf · Free Seminar Invitation Click on the link in...

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Inside the Mind of the FDA W I L L Y O U B E W I L L Y O U B E I N C O M P L I A N C E I N C O M P L I A N C E ? Current & Future Implications of the USP <232>, EP (CH. 5.2) & ICH-Q3D Heavy Metal Mandates. for cGMP and Supply Chain Security. Technical Approach Considerations. DATE: THURSDAY, MAY 15th, 2014 LOCATION: NIBRT: National Institute for Bio- processing Research & Training Fosters Avenue, Mount Merrion, Blackrock, Co. Dublin. Ireland www.nibrt.ie ITINERARY: 9:30am Welcome Reception, Registration and Refreshments 10:30 am • Introduction. Presentation: - Current & Future Implications. - Supply Chain Security. 12:00 Noon Lunch 1:00 pm • Technical Presentation • Product Presentation • Q & A 2:30 - 4:30 pm - Open Bar / Refreshments - Pharmco-Aaper / BNL booth - NIBRT Tour Free Seminar Invitation Click on the link in this email to register For Senior Purchasing & Quality Personnel Presentations Include: A comprehensive understanding of the Heavy Metal Mandates and their implications for you. Technical and Strategic insights to help guide your quality process over the next 5 years. A spotlight on the FDA’s current and future agenda of this new, long term trend including cGMP and Supply Chain Implications. Guest Speakers: Paul DiMarco President & General Manager MS Chemistry / MA Education. Jai Murthy Special Consultant Ph. D. Molecular & Cellular Biology. Harvard University. Host: Ken Finegan. Sales Manager

Transcript of Sachs Seminar Invitation - BNL Sciences Seminar.pdf · Free Seminar Invitation Click on the link in...

Page 1: Sachs Seminar Invitation - BNL Sciences Seminar.pdf · Free Seminar Invitation Click on the link in this email to register For Senior Purchasing & Quality Personnel ... quality system

Inside the Mind of the FDA

W

ILL YOU BE W

ILL YOU BE I

N C

OM P L I A

NC

E

IN

C

OM P L I A

NC

E?Current & Future Implications• of the USP <232>, EP (CH. 5.2) & ICH-Q3D Heavy Metal Mandates.

• for cGMP and Supply Chain Security.

• Technical Approach Considerations.DATE:

THURSDAY, MAY 15th, 2014

LOCATION:

NIBRT: National Institute for Bio-processing Research & Training

Fosters Avenue, Mount Merrion,Blackrock, Co. Dublin. Ireland

www.nibrt.ie

ITINERARY:

9:30amWelcome Reception, Registration and Refreshments

10:30 am• Introduction.• Presentation: - Current & Future Implications. - Supply Chain Security.

12:00 NoonLunch

1:00 pm • Technical Presentation• Product Presentation• Q & A

2:30 - 4:30 pm - Open Bar / Refreshments- Pharmco-Aaper / BNL booth- NIBRT Tour

Free Seminar Invitation

Click on the link in this email to register

For Senior Purchasing & Quality Personnel

Presentations Include:• A comprehensive understanding of the Heavy Metal Mandates and their implications for you.

• Technical and Strategic insights to help guide your quality process over the next 5 years.

• A spotlight on the FDA’s current and future agenda of this new, long term trend including cGMP and Supply Chain Implications.

Guest Speakers: Paul DiMarco President & General Manager MS Chemistry / MA Education.

Jai Murthy Special Consultant Ph. D. Molecular & Cellular Biology. Harvard University.

Host: Ken Finegan. Sales Manager

Page 2: Sachs Seminar Invitation - BNL Sciences Seminar.pdf · Free Seminar Invitation Click on the link in this email to register For Senior Purchasing & Quality Personnel ... quality system

pharma

clin

ical

flavor

fragrance

bio

-tech

general

lab

r&d

High Purity EthanolFor Bio-Pharma & other Critical Applications.

Pharmaceutical Grade SolventsThat exceed GlobalPharmaceutical Requirements.

Sterile Solvents & Custom BlendsFor Process Applications inProduction Quantities.

ISO and FDA Registration. Organic, Kosher, HACCP and cGMP operations

Producers & Manufacturers

eth

anol

quality

PHARMCO-AAPER stands apart as the premier producer and manufacturer of the highest purity pharmaceutical and analytical grade ethanol in the world. We operate the most rigorous quality system, fully integrated into a dedicated manufacturing process that provides a chain of custody and control of quality from raw materials to finished product.

In addition we manufacture high purity, multi-compendia, pharmaceutical grade solvents, sterile products and custom formulations for critical industrial, medical, biological and pharmaceutical processes that range in batch and package sizes from Kilo’s to Metric Tons. Our production manufacturing and packaging systems operate under FDA, ISO and Kosher registration that exceed cGMP and HACCP requirements as well as many other global quality demands.

Simply stated, the purity of our products, the integrity of our process and the depth of our totalquality system offers a wealth of experience and a world of solutions to evolving global markets.

A Wealth of Experience

MK014_Rev 1.1_02/13_HM

Page 3: Sachs Seminar Invitation - BNL Sciences Seminar.pdf · Free Seminar Invitation Click on the link in this email to register For Senior Purchasing & Quality Personnel ... quality system

New FDA USP <232>Heavy Metals lot-to-lot AnalysisRequired for Pharma Grade Process Solvents

ISO and FDA Registration. Organic, Kosher, HACCP and cGMP operations

MK005_Rev1.3_04/13_PD.HM

- All Lots Fully Tested for 15 Heavy Metals.- Actual Quantitative Results Required by USP <232> ( ICP-MS.)- Meets all other cGMP Requirements.- Multi-Compendia Certified (USP, EP, BP, JP etc.)- ICP-MS Tested with Fully Validated Methods.

ARE YOU

ARE YOU

IN COM P LIA

NC

EIN COM P LIA

NC

E?

Our ICP-MS Unit meets the USP <233> Requirement

Our World/GMP Grade Solvents Meet And ExceedThese Requirements Now!

Page 4: Sachs Seminar Invitation - BNL Sciences Seminar.pdf · Free Seminar Invitation Click on the link in this email to register For Senior Purchasing & Quality Personnel ... quality system

As Manufacturers of High Purity Solvents & Custom Blends our Facilities include a Class 10,000 Clean Room & cGMPKosher White Room operating under ISO & FDA registration

Multi-Compendia Solvents for Multi-National Business

All p

hotography p

roduced

in-house

MK011_Rev1.2_09/13_PD.HM

Meets EP, BP, JP, USP & ACS Specifications

ISO and FDA Registration. Organic, Kosher, HACCP and cGMP operations

Page 5: Sachs Seminar Invitation - BNL Sciences Seminar.pdf · Free Seminar Invitation Click on the link in this email to register For Senior Purchasing & Quality Personnel ... quality system

cGMP, Kosher White Roomfor Solvent Blends

Class 10,000 Clean Roomfor Sterile Blends

All

pho

togr

aphy

pro

duc

ed in

-hou

se

3 Levels of Product Validation

Full FDA Validation

Customer Directed Validation

Default – Internal Validation

Batching Tanksfor Ethanol Blends

3 Custom Product Categories

Custom Ethanol Blends

Custom Sterile Solvent Blends

Custom High Purity Solvent Blends

3 Area’s for Custom Manufacturing

Batching Tanks forEthanol Blends

Class 10,000 Clean Roomfor Sterile Blends

cGMP, Kosher White Roomfor Solvent Blends

Custom BlendsFor Critical and Industrial Processes

ISO and FDA Registration. Organic, Kosher, HACCP and cGMP operations

MK002_Rev1.4_11/13_PD.SP.HM