Biopharmaceutical quality and process development consultants in cGMP training, raw materials, aseptic processes, development, and fill/finish. Pharma management assistance, protocol preparation and data analysis.
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Biopharmpro | biopharmpro.com Reviews
https://biopharmpro.com
Biopharmaceutical quality and process development consultants in cGMP training, raw materials, aseptic processes, development, and fill/finish. Pharma management assistance, protocol preparation and data analysis.
biopharmpro.com
Biopharmpro
http://www.biopharmpro.com/GMP-Training.php
Good Science is Good Compliance. Audits and Inspection Readiness. GMP, Compliance, and Technical Training : By the hour or by the day :. Quality Systems and Quality by Design (QbD). GMP for Phase I: 2008 FDA Guidance. Quality Systems approach to FDA’s inspections (QSIT). ICH Q8, Q9, and Q10: Quality by Design. Regulatory and GMP Events. Recent topics from FDA inspections and Warning Letters. Heparin API, Melamine, and DiEthylene Glycol (2008). The 2004 Flu Vaccine Story: Root Causes and Investigations.
Biopharmpro
http://www.biopharmpro.com/Industry-Affiliations.php
Good Science is Good Compliance. Audits and Inspection Readiness. We Are Members of Various Industry Groups :. Paula J. Shadle, Ph.D. PDA, Parenteral Drug Association, Board of the West Coast Chapter of the 2005-2007, Session leader and organizing committee member for annual conference 2002-2003, member-at-large since 1989. Editorial board, BioPharm International Journal. CaSSS, the California Association of Separation Sciences. ACS, American Chemical Society. PDA: 1976 to present: Honorary Member.
Biopharmpro
http://www.biopharmpro.com/Presentations.php
Good Science is Good Compliance. Audits and Inspection Readiness. We regularly present at various meetings; we participate to stay current with industry and regulatory trends. Paula Shadle, Ph.D. Course director and speaker for professional continuing education at the University of Wisconsin, Dept of Engineering, Parenteral Drug Association (PDA), IBC (International Biological Conferences), Ohlone College, and direct-to-customer. Writing Technical Reports and GMP Investigations.
Biopharmpro
http://www.biopharmpro.com/Our-Associates.php
Good Science is Good Compliance. Audits and Inspection Readiness. Doris Conrad - contact Doris at d.l.conrad@comcast.net. Or d.l.conrad@BioPharmPro.com. Knowledgeable in developing and implementing cost effective quality, GMP compliance systems for the manufacture, packaging and shipping of sterile products which includes cold chain shipping of frozen and refrigerated products globally. Strong validation experience with sterile and non sterile bulk processes, such as, chemical synthesis, spray drying, fe...
Biopharmpro
http://www.biopharmpro.com/GMP-Consultation.php
Good Science is Good Compliance. Audits and Inspection Readiness. GMP Systems : Quality Assurance : Quality Control. Mature GMP systems may be compliant yet lacking in agility or efficiency. How can you improve these systems while maintaining compliance? Can you justify changes using good science, current GMP, and validation data? Where are the critical control points that assure quality? Where are the bottlenecks that affect cycle time and capacity?
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biopharmperspectives.com
BioPharm Physicians - Call us when your company needs a doctor
We are a highly-focused life sciences recruiting partnership. We concentrate on difficult-to-fill CMO, VP and Medical Director positions for biotech, pharmaceutical and medical device companies. We connect you to consultants for interim and short-term assignments. LEARN MORE. We recruit physicians for full time and permanent positions. LEARN MORE. We connect you to consultants for training, education and mentoring. LEARN MORE. PUBLISHED BY: Editor: BioPharm Physicians. Drug Pricing & Reimbursement.
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Biopharmpro
Good Science is Good Compliance. Audits and Inspection Readiness. Shadle Consulting offers services forBiotechnology and BioPharmaceutical firms :. We offer expertise and guidance in:. Internal and External Audits. Strategic Planning to Build Quality Systems. Experience with Clinical Trials Materials, Commercial Operations, and more.
Biopharmaceutical cGMP Manufacturing Consulting Services
Our firm delivers strategic biopharmaceutical cGMP manufacturing consulting services for biotherapeutics, vaccines and novel drug-delivery products produced with robust manufacturing bioprocesses at production sites worldwide. Biopharmaceutical cGMP Manufacturing Consulting Services. We provide the following consulting services:. Bioprocess Development, Scale-up and Technology Transfer. Due Diligence and Technology Assessment. 5111 Telegraph Avenue, #116. Oakland, CA 94609. NEW EAST COAST OFFICE.
Home « Biopharm Project Solutions Inc.
Process Project Management Compliance. Process and Project Review. Commissioning & Qualification. Manufacturing Process Science and Technology. Project Planning and Management. Media/Buffer Preparation and Use. Cleaning Development and Validation. Malvern, PA, 19355.
Biopharm Quality Assurance Profession
Biopharm Quality Assurance Profession. Thursday, April 07, 2005. The role of Quality Assurance Specialist in the biotechnology industry. Kriger QA Training: Quality Assurance Program. Http:/ www.kriger.com/. This article has been published by the International Biopharmaceutical Association www.ibpassociation.org. The project is sponsored by KRC CRO and training services ( http:/ www.kriger.com/. And ClinQua CRO ( http:/ www.clinqua.com/. Outsource Your Corporate Training. Typical work activities include :.
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