Clinical Research Staffing stock photo
May 16th, 2016

Lab Apprentices —Building a Workforce in a Tight Labor Market

Lab Apprentices are now available for CLIA, CAP and 17025 labs in California.
Lab apprentices pipet

“We are pleased with [our apprentice] who has been valuable to effectively upgrade our quality control programs, bring a youthful vision and spirit to our workforce, and help us develop a competent team for the future,” said Kevin Kimura of Red Shell Foods, Inc. in Sante Fe Springs, CA.

We are hoping to bring the same satisfaction our food companies have to labs.

Quality is important in all industries, but it is particularly important in Read the rest of this entry »

September 8th, 2015
Sample Clinical Trial Timeline used by Clinical Planning Manager

Sample Clinical Trial Manager Timeline

Sr. Clinical Planning Manager

Large Pharma Client Needs Your Clinical Trial Expertise!

A Clinical Planning Manager, capable of handling 12 teams with 25 members each of both internal and external members, is urgently needed by our client. You will use your 8 + years of industry experience to proactively identify potential pitfalls and steer the team around them. You will Read the rest of this entry »

July 30th, 2015

Apprentices Available

Apprentices available to build a fresh new pool of talent in Quality, Regulatory, Clinical and Medical roles for Food, Biotech, Pharmaceutical and Medical Devices. Our grants cover part of the cost of training and employing apprentices while they work toward an industry certification, typically one or two years.  We currently have two Read the rest of this entry »

October 17th, 2014

Regulatory Inspections and How to Manage Them

You are Invited to an Evening Meeting

Regulatory Inspections
and How to Manage Them   

 

Orange County Regulatory Affairs Discussion Group (OCRA) 

 

Wednesday, November 5, 2014 

5:30 – 9:00 pm 

Read the rest of this entry »

October 17th, 2014

The Reproducibility Crisis in Biomedical Research

New quality practices developed by the ASQ FD&C Division could change the trend in the Reproducibility Crisis in Biomedical Research!

“The productivity of modern drug development has been steadily Read the rest of this entry »

May 9th, 2014

SABPA Bio-Pharma Conference 2014

Date:                     June 21, 2014, 8:00am – 4:50pm Read the rest of this entry »

January 6th, 2014

ISPE San Francisco/Bay Area Dinner Meeting 1/23/14

Presents

 

CEO Night

Featuring Three Industry Leaders

Dinner Meeting
Thursday, January 23, 2014
Read the rest of this entry »

October 16th, 2013

Risk Management

Orange County Regulatory Affairs Discussion Group

Thursday, November 14, 2013

Location:

Irvine Marriott

18000 Von Karman

Irvine, CA  92612

949-553-0100   Read the rest of this entry »

October 10th, 2013

Clinical Trials 101

Joint Meeting with San Diego Regulatory Affairs Network

(SDRAN)

and 

Orange County Regulatory Affairs Discussion Group

 

Wednesday, October 30, 2013   Read the rest of this entry »

March 22nd, 2013

The 12th SABPA Education and Career Development Event 

When:  11:30 am to 2:00 pm, Saturday, April 6, 2013

Where: TBD

Registration: https://www.123signup.com/register?id=bcbsk

$10 ($5 student) until April 1st online; $20 onsite ($10 student onsite)

Weblink: http://www.sabpa.org/web/news_details.php?ID=457

 

Summary: Dr. Yuan Xu (VP, Novartis) and Mr. Brian O’Callaghan (CEO, Sangart) will discuss their career paths, views of leadership, and insights on the skills essential for anyone aspiring to achieve career success in the pharmaceuticals/biotech industry.
Speakers:

Yuan Xu, Ph.D.

Dr. Yuan Xu is currently the Vice President and Head of Biotherapeutics Development Unit located at Novartis La Jolla site. She previously served as Global Head and VP of Process Sciences, Production and Quality at Novartis Biologics, and VP and Site Head for Novartis Biologics at Basel Site from 2008 to 2011. Prior to joining Novartis, Dr. Xu held leadership positions, with increasing responsibilities, at several pharmaceutical and biotech companies including Genentech, GlaxoSmithKline, Chiron Corporation, and Amgen. Dr. Xu has worked on many biotherapeutics including various forms of antibodies, recombinant proteins, antibody-drug conjugates, therapeutic vaccines, gene and cell therapies. Dr. Xu has extensive scientific/technical expertise and development/regulatory experience with multiple successful biotech products including Activase, Pulmozyme, Rituxan, Herceptin, TNKase, Xolair, Raptiva, Avastin, Lucentis, Bexxar, Bacaplemin, Proleukin, Epogen, Enbrel, Prolia, Extavia and Ilaris. Dr. Xu did Postdoc training in Molecular Virology and Gene Therapy from University of California at San Diego Medical School. Dr. Xu has a Ph.D. in Protein Biochemistry from the University of Maryland at College Park and a B.S. in Biochemistry and Molecular Biology from Nanjing University in China.

 

Brian O’Callaghan

Mr. Brian O’Callaghan joined Sangart as President and Chief Executive Officer in June 2008. Mr. O’Callaghan brings a breadth of experience to Sangart, having held senior positions with a number of pharmaceutical and biotechnology companies in both Europe and the US. These include senior positions with Pfizer in the UK and Merck Serono in Germany, before becoming President and CEO of BioPartners, a Swiss based biotechnology company. Since relocating to the US, Mr. O’Callaghan has held senior management positions at Novartis, where he served as General Manager of their Transplantation, Immunology and Infectious Disease businesses, as well as at Covance, a clinical research firm, where he served as General Manager of their Cardiac safety and IVRS businesses. Mr. O’Callaghan joins Sangart from NPS Pharmaceuticals, where he served as Chief Commercial Officer. Mr. O’Callaghan brings his extensive general management background in the pharmaceutical, biotechnology and clinical research sectors, as well as his significant international experience, to lead Sangart through regulatory submission and commercial launch of MP4. Last October, Mr. O’Callaghan led a senior executive team to visit 9 Chinese companies in 5 cities to explore potential partnership opportunities.
Schedule:

11:30 am: Registration and Networking

12:00 pm: Light lunch

12:30 pm: Welcome & speaker introductions

12:40 pm: Presentations

1:30 pm: Q&A

March 4th, 2013

Critical Regulatory and Compliance Issues with the US FDA in the 21st Century

 

Spring AOAC SCS – USP WCDG Joint Conference – “Critical Regulatory and Compliance Issues with the US FDA in the 21st Century”

 

When:  7:00 am to 4:00 pm, Thursday, March 7 & Friday, March 8, 2013 

Where: US FDA facility located at 19701 Fairchild, Irvine, CA 92612

Conference Organizer: AOAC Southern California Section (SCS) – USP Western Compendial Discussion Group (WCDG)

Conference Summary: This conference will be focused on Dietary Supplements and on Method Development & Validation.

Registration: please visit the AOAC SCS Website: http://www.aoac-scs.org/2013_Spring_Conference.html. As a benefit, SABPA members (need to mention that you are a SABPA member when registering) can register to this 2-day conference with the same registration fee as AOAC SCS members without paying the AOAC SCS membership fee.

 

DAY 1 – Thursday, March 7, 2013  

7:00 A.M.        Registration

8:30 A.M.        Welcome Remarks by

Alonza CruseDirector,

Los Angeles District Office, US FDA, Irvine, CA

William Martin, Ph.D.,

Laboratory Director, PRL-SW, US FDA, Irvine, CA

Yan-Bo Yang, Ph.D.,

President, Biopharmadev, Inc., Corona, CA, & President, AOAC SCS

Sumit Sen, Ph.D., US FDA, PRL-SW, Irvine, CA,

President, USP WCDG,

& Meeting Host

 

9:00 A.M.        Topic: LOS-DO Compliance Actions against Dietary Supplement Firms

Blake Bevill,

Compliance Director, LOS-DO, US FDA, Irvine, CA

9:50 A.M.        Topic: Update on NIH’s Activities in the area of Dietary Supplements

Joseph M. Betz, Ph.D.

 

Director, Analytical Methods and Reference Materials Program, Office of Dietary Supplements, National Institutes of Health, Bethesda, MD

10:40 A.M       Refreshment Break

11:00 A.M.      Topic: Dietary Supplements Current Adulteration Issues to Consider while

Setting Product Specifications

Mark Roman, Ph.D.

President, Tampa Bay Analytical Research, Inc., Clearwater, FL

11:50 A.M.      Topic: Challenges regarding Reference Standards in Dietary Supplements

Mitzi Rettinger, Vice-President, Sales & Marketing, Cerilliant Corporation, Round Rock, TX

12:40 P.M.       Sponsor Presentations

1:00 P.M.         Lunch Break

2:00 P.M.         Panel Discussion Session

4:00 P.M.         Adjourn

DAY 2 – Friday, March 8, 2013

7:00 A.M.        Registration

8:00 A.M.        Topic: Import Compliance Related Issues related to Dietary Supplements

Daniel Solis

Director, Import Operations  Branch, LOS-DO, US FDA, San Pedro, CA

8:50 A.M.        Counterfeit C of A’s: From Raw Material to Finished Product-What to Look For?

Jana Hildreth

CEO & Technical Director, Blaze Science Industries LLC, Rolling Hills, CA

9:40 am           Topic: Industry Involvement in USP Monograph Development for Dietary Supplements

Blake Ebersole

Technical Director, Verdure Sciences, Noblesville, IN

10:30 A.M.      Refreshment Break

10:50 A.M.       Topic: USP Update/Activities on Dietary Supplements

Nandakumara (Nandu) Sarma, R.Ph., Ph.D.

Director, Dietary Supplements, USP, Rockville, MD

11:40 A.M.      Phase Appropriate Method Development and Validation

Aryo Nikopour
Vice-President, Scientific and Technical Services, Irvine Pharmaceutical Services, Irvine, CA

12:30 P.M.       Method Validation and Verification in Dietary Supplements

Lorraine Shelton, ASQ CQA

HSEQ Officer, Exova Health Sciences, Santa Fe Springs, CA

1:20 P.M.         Sponsor Presentations

1:45 P.M.         Lunch Break

3:00 P.M.         Panel Discussion Session

4:30 P.M.         Adjourn

March 4th, 2013

Innovations in Biologics Discovery and Development

 

SABPA Science & Technology Forum – Innovations in Biologics Discovery and Development (March 23, 2013)

 

Innovations in Biologics Discovery and Development

 

Date:                March 23, 2013, Saturday, 8:30am to 1:00pm (Breakfast and lunch will be provided)

Location:         Institute of Americas, UCSD, (Direction available at http://www.sabpa.org/web/news_details.php?ID=449)

Registration:   https://www.123signup.com/register?id=bmgsg

$20 for online registration, $10 for students and  post-docs. $40 for on-site registration, Online registration ends March 20, 2012

 

For the past two decades, biologics have revolutionized the treatment of diseases such as rheumatoid arthritis, psoriasis, Crohn’s disease, diabetes, multiple sclerosis, and are widely used in treating a variety of cancers. Biologics is a rapidly developing field of therapeutics and there is a trend for pharmaceutical and biotech industries to drift toward biologics development due to the promise of biologic drugs.

 

At the SABPA Science & Technology Forum XI, we bring together leaders in academia and the pharma/biotech industry to discuss current trends in biologics discovery and development, as well as challenges in the field. The presentations will address new technologies in discovering novel biologic therapeutics including the use of unnatural amino acids, somatic hypermutation and directed molecular evolution as well as developing biologics delivery platforms. The meeting will cover therapeutic antibodies, proteins, peptides, vaccines and therapeutic areas from cancers, autoimmune to cardiovascular diseases.

Event Program

 

8:00-8:30 Registration & Breakfast
8:30-8:35 Opening Remarks
8:35-8:40 Chairperson of session 1
8:40-9:15 Peter Schultz, Ph.D.

Professor of Chemistry, Scripps Research Institute; and Director of California Institute for Biomedical Research

Title:A Chemist’s Foray into Translational Medicine.

9:15-9:45 Thomas F Bumol, Ph.D.

Vice President of Biotechnology and Autoimmunity, Lilly Research Laboratories, Lilly Biotechnology Center-San Diego

Title: Biotechnology as a Sustainable Source of Pharmaceutical Innovation: the Lilly Biotechnology Strategy.

9:45-10:15 David King, Ph.D.

Chief Scientific Officer, AnaptysBio Inc

Title: Generating Improved Antibody Therapeutics through Somatic Hypermutation in vitro

10:15-10:40 Refreshment Break, Exhibit & Networking
10:40-10:45 Chairperson of session 2
10:45-11:15 Jeremy Barton, M.D.

Vice President, Biotherapeutics Development, Pfizer

Title: Antibody Drug Conjugates: Blockbusters of the Next Decade?

11:15-11:45 Henry Ji, Ph.D.

Chief Executive Officer and President, Sorrento Therapeutics

Title: The G-MAB®Library Technology-Discovery and Development of New Human Therapeutic Antibodies

11:45-12:45 Panel Discussion: Biologics Development

Moderator:                                       

Steve Prestrelski, Ph.D., M.B.A.

Chief Scientific Officer, Xeris Pharmaceuticals, Inc.

Panelist:

1. Bhawanjit Brar, Ph.D., Senior Director, Zensun USA

2. Jean I Liu, M.S., J.D., Vice President, General Counsel and Secretary, Halozyme Therapeutics, Inc.

3. Brenden S. Gingrich, Ph.D., J.D., Partner, Knobbe Martens

4. Tim Tian, Ph.D., Senior Scientist, Laureate BioPharma

5. Olivier Laurent, Ph.D., Director, Protein Science, CovX

12:45-12:50 Closing Remarks
12:50-14:30 Lunch
January 28th, 2013

Drug Shortages from the FDA, Industry, and Consumer Perspectives

Orange County Regulatory Affairs Discussion Group (OCRA)

 Friday, February 22, 2013

8:00 am to Noon

Free of Charge
OCRA Membership is Required

(Employees of Host Locations do not need to be Members)

Four Locations To Choose From:   

Amgen
One Amgen Center Drive; Thousand Oaks, CA  91320

Beckman Coulter

250 South Kraemer Boulevard; Brea, CA 92821

 Bausch + Lomb

50 Technology Drive; Irvine, CA 92618

 Ardea

4939 Directors Place; San Diego, CA 92121

 (see below for driving directions to each location)

 

Program Managers:

Damon Jones, Vice President, Director of Operations, McGuff Pharmaceuticals, Inc.

 Tania Hoffman, MSRS, Sr. Regulatory Affairs Manager,  Spectrum Pharmaceuticals, Inc.

 Ruchika Raval, RAC, Principal, Global Biopharmaceutical Regulations, Inc.

Synopsis

Disruptions in the supply of potentially life-saving medications have become a critical public health issue. Many factors lead to prescription drug shortages.  Manufacturers are often unable to provide timely and complete information on the causes and potential resolution of these shortages to the public, which often leads pharmacies and healthcare facilities to try to find ways of avoiding negative outcomes in the patients they treat. In 2011, President Barack Obama signed an Executive Order directing the Food and Drug Administration to take on a greater role in reducing and preventing drug shortages. In 2012, Title X of the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, which lists the mandatory reporting requirements for manufacturers and provides FDA with important new authorities to help alleviate drug shortages. This program will look at drug shortages from the FDA, industry, and consumer perspectives and highlight efforts on all three fronts to manage this challenging issue.    

Speakers:

FDA Perspective 

Jeannie David, Program Management Officer, CDER Drug Shortage Program, FDA
(live from FDA Headquarters)

The speaker will discuss efforts underway at the FDA to address drug shortages, including interactions between the Agency and industry on manufacturing issues to maintain the safety and quality of medically necessary products while ensuring their continued availability.

 

Jeannie David, M.S. has been with the FDA since 2008. She is currently a Program Management Officer in the CDER Drug Shortage Program. She brings experience from her role as a Regulatory Health Project Manager in the CDER Office of New Drug Quality Assessment, the chemistry, manufacturing and controls (CMC) review division for new drug applications (NDAs), where she managed pre- and post-marketing applications, President’s Emergency Plan for AIDS Relief (PEPFAR) submissions, and presented a talk on Preparing for CMC Meetings with the FDA at the DIA 2012 Annual Meeting. Previously, Jeannie worked 7 years in the biopharmaceutical industry as a research scientist at Roche Palo Alto. She has a M.S. degree in neuroscience from the University of Wisconsin-Madison.  Ms. David will speak to us from Washington D.C.

 

Industry Perspective 

Scott McCarty, Risk Management Director, Amgen, Inc.
(Speaker will be at Amgen location) 

Scott McCarty has been with Amgen for 15 years, serving in a variety of roles in Operations and Quality Assurance. He is currently Director of Operations Risk Management, with responsibility for identification, characterization, and evaluation of risks to Amgen’s product supply chain. His prior Amgen experience includes leadership of a commercial product launch team and implementation of Amgen’s global change control system.

Prior to joining Amgen, Scott was a 20-year Navy fighter pilot, logging many aircraft carrier-based flight hours in F-4 and F-14 aircraft. Scott holds a bachelor’s degree in Economics from Stanford University, a master’s degree in Aeronautical Engineering from the Naval Postgraduate School, and the degree of Engineer in Aerospace Engineering from the University of Southern California.

 

Consumer Perspective

Speaker TBD
The speaker will discuss the effects of drug shortages on hospitals and patients.   

Schedule

8:00 – 8:45 am

Registration and Security Check In

Continental Breakfast 

 

8:45 – Noon  

Speaker Presentations 


REGISTRATION INSTRUCTIONS

  

For Amgen, Beckman Coulter and Ardea employees, please email Rob Fleming (rob.fleming@yahoo.com) with your name(s) and email addresses for each attendee.

All others please follow the instructions below. 

 

 

Be sure to log on and join or renew your OCRA Membership.  If you have not used our online system, you will need to create a new user profile before registering

http://www.ocra-dg.org/

  

Once you are logged on, click on “Register for a Meeting” on the right-hand side of the page. Next click on the meeting for which you would like to register, then follow the online instructions. You will receive an immediate confirmation.

CLICK HERE TO DOWNLOAD EVENT FLYER

 

Orange County Regulatory Affairs Discussion Group

5319 University Dr., Suite 641, Irvine, CA 92612

Tel:     949-387-9046

Fax:     949-266-8461 or 949-387-9047

Email: ksyre@cox.net

 

OCRA’s non-profit Federal Tax ID# 33-0630455    

 

 

DRIVING DIRECTIONS

 

Amgen

One Amgen Center Drive

Thousand Oaks, CA  91320

 

Note:  Please arrive at 8:00 am sharp as you need to be escorted to another building using Amgen’s shuttle.   

 

Please bring your photo ID for check in with Amgen security

Traveling Northbound on 405 and 101 Freeway

Take 405 Freeway North to 101 (Ventura) Freeway North.

Exit 47A Rancho Conejo Blvd.

Turn Right onto Ventu Park Road

Make a Left (before light at Pauling Dr.) into Building #37 parking lot.

Visitors to check in at Building #37 Lobby

Amgen Contact:  Amy Gonzales

Traveling Southbound on 101 Freeway

Traveling 101 S (towards Los Angeles)

Exit 47A, Borchard Rd. / Rancho Conejo Blvd.

Turn Left on Borchard Rd / Rancho Conejo Blvd

Continue to follow Rancho Conejo Blvd.

Turn Right on Ventu Park Road

Make a Left (before light at Pauling Dr.) into Building # 37 Parking Lot

Visitors to check in at Building #37 Lobby

Amgen Contact: Amy Gonzales

Beckman Coulter, Inc.

250 S. Kraemer Blvd.
Building #A
Brea, CA  92822

Directions from LA:
Take 405 S to 22 East.  Then take 57 N to Imperial Blvd.  Turn right onto  Imperial Blvd.  Go to the 5th Light and turn left onto Kraemer Blvd. Beckman Coulter will be on the right hand side.

Directions from San Diego:
Take 405 N to 55.  Then take 57 N to Imperial Blvd. Turn right at the end of the exit onto Imperial Blvd. Go to the 5th Light and turn left onto Kraemer Blvd.  Beckman Coulter will be on the right hand side.

Bausch + Lomb

50 Technology Drive

Irvine, CA 92618

 

From San Diego

Take 5 Freeway North

Exit at Alton Parkway (Exit 94B)

Turn Right onto Alton Parkway.

Take 1st Left  onto Technology Dr. W.

Bausch + Lomb will be on the Right.

 

From Long Beach

Take 405 Freeway South.

Exit at Irvine Center Drive (Exit 1C).

Turn Left onto Irvine Center Drive.

Turn Right onto Baranca Parkway.

Turn Left onto Technology Drive.

Bausch + Lomb will be on the Right.

Ardea

4939 Directors Place

San Diego, CA 92121

 

From San Diego Airport

Take 5 Freeway North.
Exit at Sorrento Valley Road (Exit 30).
Turn Left onto Roselle St.
Take the 1st Right onto Sorrento Valley Road.
Take the 2nd Right onto Vista Sorrento Pkwy.
Turn Left onto Directors Place.
Ardea will be on the Right.

From Oceanside
Take 5 Freeway South to 805 Freeway South.
Exit at Mira Mesa Blvd (Exit 27).
Turn Left onto Sorrento Valley Road.
Turn Left onto Vista Sorrento Pkwy.
Turn Right onto Directors Place.
Ardea will be on the Right.

September 18th, 2012

SOCRA 21st Annual Conference September 21-23, 2012

 

Please join Rosemarie Christopher at the Society of Clinical Research Associates (SOCRA) 21st Annual Conference at the RIO All Suite Hotel in Las Vegas on September 21-23, 2012!

Clinical research professionals including investigators, research coordinators, research associates, project managers, consultants, educators, and administrators. Such participants may be affiliated with medical centers; cooperative research groups; research consortia; pharmaceutical, device, and biotechnology companies; contract research organizations; site management organizations; and independent research firms are all invited to attend. Register now!

  • Stop by MEIRxRS Exhibit Booth #10 for some goodies : )
  • Listen to Rosemarie Christopher present how to Manage a Multi-generational Workforce on Sunday, October 23rd at 10:10am
  • Earn Continuing Education Credit Hours
  • Network with over a thousand industry professionals in CRO, pharmaceutical, device and biotechnology companies
August 23rd, 2012

How To Get It Right The First Time

 

ASQ FDC SCDG Presents…

How To Get It Right The First Time

Thursday, August 23, 2012

5:30 p.m. – 8:30 p.m.

Baxter BioScience

1 Baxter Way #100, Thousand Oaks, CA 91362

Speaker & Host:  Mary Thorsness, Quality Manager – CAPA Division, Baxter BioScience

Mary graduated with a bachelor’s in Biology from the University of California at San Diego. Mary has been  with Baxter since 2005 as BioScience Division CAPA Manager and is responsible for the division CAPA program in 15+ sites throughout the US and Europe. Among her responsibilities, Mary is a certified Lead Investigator trainer responsible for training potential CAPA owners, approvers, and other trainers.  Prior to her current position at Baxter, was had extensive leadership experience in the biotechnology and medical device industries.

Abstract:
Which Data Streams You Should be Analyzing and How: There are an overwhelming number of data streams that can be analyzed and reported on. How do you sort the “essential” and focus on them? Do these reported data streams stay the same through the years, or do they evolve as your industry, company, and regulatory climate evolves?

This interactive session will identify which data streams you should use to gauge the health of your products and quality system and how to measure and report them in a way that will be understood by those who review them.

Takeaways

 Identify which data streams you should use to gauge the health of your products

– Identify which data streams you should use to gauge the health of your Quality system

– How to measure and report that data in a way that will be understood by those who review it

Speakers:  Niedre Heckman, Manager – Regulatory Affairs, Baxter BioScience and Kumari Devulapalle, Chemist – 3M

Niedre Heckman is a Quality Management professional with nearly two decades of hands on expertise in quality assurance, quality control, regulatory affairs and research and development. She is a process oriented leader with diversity of experience across medical products. She couples experience in quality systems and regulatory compliance with business acumen to develop strategic solutions that achieve organizational goals.

Currently, Niedre works in Regulatory Affairs at Baxter Healthcare Corporation.  Prior to this, she worked for 3M in Quality and in Regulatory Affairs positions.

Niedre is involved with the professional organizations ASQ and RAPS, where she holds the CQA and RAC certificates, respectively.  Niedre has an MS in Chemistry from UC Irvine and an MPH from UCLA.

Dr.  Kumari Devulapalle, has extensive experience in biochemistry and biotechnology both in academics and biopharmaceutical industry over 20 years. She has contributed to different NIH grants on enzyme kinetics and protein modeling  during her work at University of Southern California before she moved to Amgen analytical R & D on method development and validation for therapeutic biomolecules.

  • She has been working for the past 8 years at 3M Northridge, in quality control aspects of the biopharmaceuticals where she is leading the implementation of Six Sigma Lean projects. She is also known in adapting Right The First Time, analytical method improvements for product testing and release.

Abstract:

The majority of drug products are not discretionary and are often urgently needed.  Depending on the type of product, for example biologics, shelf-life and storage factor into the urgency of getting products to the customer.  Thus, there is a business need and responsibility to provide high quality products in a reasonable, and sometimes expedited, manner.  This presentation considers best practices for getting drug products to the customer in two areas: (1) Product release of pharmaceuticals from the Quality Assurance Unit, and (2) Global product registration enabling world-wide product accessibility to customers.  This audience interactive session will provide some dashboard metrics used to ensure processes for efficiently getting product to customers are tracked for continuous improvement.  The session will also bring awareness to some of the interesting details that can slow down the process.

Takeaways

  • General understand of metrics than can be applied to product release and product global expansion
  • Tools that can be implemented in a high-volume quality control laboratory
  • Awareness of how US compliance issues can slow down or stop global expansion

AGENDA

5:30 pm – Registration and Networking

5:45 pm – Dinner

6:00 pm – Welcome and Introductions

6:15 pm – Speaker:  Mary Thorsness

7:00 pm – Break

7:15 pm – Speakers:  Niedre Heckman and Kumari Devulapalle

8:00 pm – Q & A

8:15 pm – Evaluation and Raffle Drawings

8:30 pm – Adjournment

** Dinner is included with your registration. Register now at http://www.eventbrite.com/event/4024074114 

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