Shadle Consulting Services
Good Science is Good Compliance
:: Our Associates ::
Doris Conrad - contact Doris at or
Doris has extensive expertise and hands-on experience with the manufacture of sterile, aseptically filled products (powders, liquids, and lyophilized) on barrier protected "open"(classic) filling lines and in isolators. She has 20+ years of in-depth experience in QA and regulatory compliance for the primary and secondary manufacturing of vaccines, validation of new facilities, CMC and ELA sections submission preparation, and GMP/ PAI Inspections of API and secondary manufacturing facilities. She has a strong background in key areas of the pharmaceutical and biological manufacturing.
Quality Systems: 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.
Validation: Strong validation experience with sterile and non sterile bulk processes, such as, chemical synthesis, spray drying, fermentation and cell culture technology and the secondary manufacturing of vials and syringes on high speed aseptic filling lines using barrier or isolator technology. Experience with equipment, technology and validation of lyophilized dosages, the Abbott Advantage System, the CVFL (Closed Vial Filling Line), terminal sterilization and on-line gamma irradiation for surface sterilization.
Compliance: Solid experience with developing site specific strategies for both CBER and CDER PAI and GMP inspections, training inspection teams, performing critical documentation reviews and providing support for QA during the inspection. Post inspection, plans strategies and develops QA procedures for corrective actions to resolve 483 Observations. Facilitates site’s QA/Manufacturing team to implement corrective actions. Skilled in developing Quality Assurance policies and procedures to reflect FDA’s Quality Systems approach to inspections. Prepares BLA and NDA CMC supplements and DMF submissions.
Before starting her consulting career in 2003, Ms. Conrad was Director Quality Assurance Vaccines, North America at GlaxoSmithKline’s facility in Rixensart, Belgium. Before that, she was director of QA/QC Anti-infectives for GSK in Conshohocken, PA, and Director of QA/QC for Beecham Laboratories in Piscataway, NJ. She was a QA corporate representative to the Pharmaceutical Research and Manufacturers of America (PhRMA), and is a member of the PDA where she held the offices of Director and Secretary, as well as chairing several committees, organized the “Vaccines Interest Group”, and served on task forces to prepare Technical Reports and respond to FDA guidelines. Doris received her BS in Chemistry from Hunter College and has MS studies in Organic Chemistry.
Mary L. Davis - contact Mary at
Mary L. Davis provides vendor compliance auditing and customized quality systems development and implementation services for small to mid-sized biotech/drug product companies.

Mary has over 27 years of experience in the pharmaceutical and medical device industries with 23 years of broad based experience in cGMP/cGLP compliance and quality systems management. She worked for Cetus, Chiron, Alza, COR Therapeutics and Millennium Pharmaceuticals as well as several small clinical development companies. The variety of companies she has worked for has provided her with management and hands on experience with a wide variety of pharmaceutical products and technologies including Small Volume Parenterals, Solid Oral Dosage Forms, Ophthalmics, Transdermal Delivery Systems, Small Molecules, Active Pharmaceutical Ingredient Manufacturers and sterile and non-sterile devices. During her career she has led or participated in over 200 cGMP and cGLP internal and supplier compliance audits in North America, Europe and Asia. In addition to auditing manufacturers of the above product types she has audited a wide variety of raw material and intermediate suppliers, distribution centers, contract service providers, contract laboratories and cGLP facilities (both bioanalytical laboratories and animal testing facilities). She also has extensive experience in developing and implementing quality systems required under pharmaceutical and GLP regulations.

Mary earned her BA, with a double major in Biochemistry and Cell and Molecular Biology, from San Francisco State University. She has certificates from UC Berkeley Extension in Project Management and Quality Improvement and has been an American Society for Quality Certified Quality Auditor since 1995.
Madelyn Marino, RAC - contact Madelyn at
Madelyn has 30 years experience as a quality professional in the biopharmaceutical industry. She has worked for Bayer, Genentech and Amgen as well as contributed greatly to a number of clinical development companies, including Cortech, Onyx, Raven and Geron. Her experience includes establishing and implementing quality systems for a variety of biopharmaceutical products including hESCs, proteins, peptides, oligonucleotides, MAbs, and therapeutic adenovirus from early phase development through pre-commercialization. She has been head of quality control and helped design commercial quality control laboratories. She has method development and method and facility validation experience. As head of Quality, she has led strategic planning and implementation of comprehensive Quality Systems, participated in due diligence assessments as well as process and method transfer to a variety of contract manufacturing and testing facilities. She is expert at assessing, developing, and implementing quality systems associated with in-house production, contract manufacturing/testing and supplier performance to ensure compliance with cGMP and GLP. Madelyn has participated in PAIs and other FDA audits and meetings and is a member of PDA and RAPS. She holds a BA in Biology from Mills College and holds certification in regulatory affairs (RAC).
Robert Hageman, Ph.D. - contact Robert at
Robert has 25 years of experience in the biopharmaceutical industry, covering quality control, process and analytical development, and research. He was most recently Director of Quality Control at Scios, where he was responsible for release testing, stability testing and management, and general management of the quality control operation for commercial products. Robert represented QC during 4 FDA inspections during which no 483 observations were issued. Prior to Scios, Robert was the Director of Quality Control at Chiron, where he was responsible for laboratory operations for multiple commercial products, including release, stability and in-process testing. In addition to representing QC during FDA and other health authority inspections, Robert assisted in resolving 483 observations from these inspections. His focus in these QC positions has been on upgrading the compliance and operational effectiveness of the laboratory, and insuring smooth QC interactions with CMOs. He has been responsible for the transfer of all release and stability testing for a product to an additional testing location, along with the development and validation of test methods for several products. He has assisted in the validation and implementation of new and upgraded computer systems including CAPA, document management, chromatography and stability systems. He was also the primary author on justifications for major changes to specifications and the stability program which were approved by the FDA. At different times, Robert has represented QC, analytical development or process development on process validation teams. Prior to joining QC, Robert spent 10 years in analytical and process development at Chiron and Synergen, as well as 8 years in various research and development roles at biotech companies in the Midwest.Robert received his BS in Chemistry from UC Berkeley, and his Ph.D. in Biochemistry from UW Madison. He has been a member of the ACS for 20 years and a PDA member for over 10 years.
Ann Daus, Ph.D.
New associate, info coming soon!