FDA cGMP Compliance News and Tips by Expertbriefings.com

FDA cGMP Compliance News and Tips by Expertbriefings.com

January 3rd, 2014 // 5:14 am @

Below are the original Expertbriefings.com cGMP and FDA-related stories for 2014. Be sure to review our new FDA Digest e-newsletter – learn FDA news and compliance tips, and also read our exclusive 483 and warning letter reports.

FDA cGMP Compliance News and Tips

  1. March 4 – Will OTC Lipitor Win FDA Approval?
  2. Feb. 26 – FDA Overhauls Drug Approval Path for OTC Drugs
  3. Feb. 19 – FDA Chief Says Indian Drugmakers Must Improve cGMP Quality
  4. Feb. 13 – FDA Is Refusing to Allow Ranbaxy Labs to Export from Banned Factories
  5. Feb. 10 – FDA Seeks More Information on Female Libodo Drug
  6. Feb. 10 – How Effective Are FDA Approvals?
  7. Feb. 3 – FDA Investigating Risks of Testosterone Therapy
  8. Jan. 30 – FDA Says Aleve Is Safer for Heart Than Other NSAIDs
  9. Jan. 23 – Evidence Quality That FDA Uses to Approve Drugs Varies Widely
  10. Jan. 20 – Remove a Wart, Burn Down Your House?
  11. Jan. 20 – MRC Tells Congress – Do Not Pass Legislation – Wait for FDASIA Report
  12. Jan. 15 – FDA Warns That Acetaminophen Dosages Over 325 MG Can Cause Liver Damage
  13. Jan. 10 – FDA: OTC Laxatives Can Kill
  14. Jan. 8 – eTMF Use Still Not Nearly As High As It Could Be
  15. Jan. 7 – How Dangerous Are E-Cigarettes?
  16. Jan 6 – Wanted by FDA – Gum Chewing Tester
  17. Jan. 6 – Company in VA Governor’s Supplement Scandal Receives FDA Warning
  18. Dec. 14 – FDA Approves 1st Device to Combat Migraine Headaches
  19. Dec. 14 – FDA Cracking Down on Anti-Bacterial Soaps
  20. Dec. 11 – FDA Sends Harsh Warning Letter to Houston Cancer Doctor
  21. Dec. 9 – 23andMe Still Optimistic Despite FDA Warning
  22. Dec. 9 – GSK Research Based on China Data Is Retracted
  23. Dec. 5 – 23andMe to Stop Test Sales After FDA Order
  24. Dec. 4 – Major Job Cuts at Merck in Ireland, Forest Labs, Eisai
  25. Dec. 2 – Main Wockhardt Drug Plant in India Banned by FDA
  26. Nov. 24 – DNA Test Maker Hit with Nasty FDA Warning Letter
  27. Nov. 21 – HHS OPDP Warning Letter Rips Kadmon Pharma
  28. Nov. 21 – Layoffs Continue in Pharma in November
  29. Nov. 20 - J&J To Pay $2.5 Billion to Settle Hip Replacement Lawsuit
  30. Nov. 18 – Merck Ends API Production in Plant in Puerto Rico
  31. Nov. 15 – Chicago Government Issues Subpoena to J&J in Investigation
  32. Nov. 14 – House of Representatives to Grill FDA on FDASIA
  33. Nov. 13 – Another Nasty 483 for Hospira
  34. Nov. 13 – What You Must Know About New Cholesterol Guidelines
  35. Nov. 7 – Shire Cutting More UK R&D Jobs – CEO Overhauls Operations
  36. Nov. 6 – FDA Trying to Increase Placement of Auditors in China
  37. Nov. 5 – J&J Pays $2.2 Billion to End FDA Drug Probes
  38. Nov. 5 – FDA Looking Into Advertising of ADHD and Acne Drugs in Teens
  39. Nov. 4 – GSK Execs Facing Bribery Charges in China
  40. Oct. 30 – New Study Casts Doubt on FDA Shorter Drug Approval Time
  41. Oct. 30 – Vertex to Chop Over 300 Jobs, and Pay Back MA Tax Credits
  42. Oct. 28 – FDA Recommends More Restrictions on Some Painkillers
  43. Oct. 25 – Interesting Hire – Simcere Hires Scandal-Plagued GSK R&D Exec
  44. Oct. 25 – Researcher at Bristol Myers Faked Data in Grants and Doctoral Thesis
  45. Oct. 24 – Agila Hit With Serious 483 and Warning Letter – Holes in Gloves?
  46. Oct. 16 – Government Shutdown Affecting FDA Drug Approvals
  47. Oct. 16 – FDA Issues Recall for B. Braun Medical Antibiotic
  48. Oct. 16 – FDA Acting at Lower Capacity During Shutdown, But User Fees Helping
  49. Oct. 15 – Is FDA Going to Recommend the Amarin Fish Oil Pill?
  50. Oct. 14 – UK’s MHRA Blasts Wockhardt Plant for cGMP Problems
  51. Oct. 10 – Who Will Succeed Janet Woodcock at FDA?
  52. Oct. 10 – FDA Favoring DUNS for Manufacturing Plant IDs in FDASIA
  53. Oct. 9 – Surprise FDA Visits Rising in India
  54. Oct. 9 – Lilly Employee Disaster – Charged With Stealing R&D Secrets
  55. Oct. 8 – Should Pharma Company Pay Punitive Damages?
  56. Oct. 7 – J&J Must Warn Consumers About Ties Between Talcum Powder and Ovarian Cancer
  57. Oct. 7 – Boehringer Ingelheim Shuts Down Ben Venue Forever
  58. Sept. 27 – Pharmaceutical Shortages Persisting as Manufacturing Problems Continue
  59. Sept. 27 – Japan Plans to Invade Novartis Offices for Diovan Scandal
  60. Sept. 26 – Burzynski Research Institute IRB Fails Another FDA Audit
  61. Sept. 26 – With FDASIA, FDA Increases Inspections of Indian Drug Facilities
  62. Sept. 23 – Indian Drugmaker USV Slammed with FDA 483
  63. Sept. 23 – Do Cholesterol Lowering Drugs Cause Cataracts?
  64. Sept. 19 – Drug Repackager Slammed With Consent Decree for Mislabeling
  65. Sept. 19 – What Did in Ranbaxy – Hair, Oil Spots and Bathrooms Without Water
  66. Sept. 18 – Ranbaxy Labs Import Alert Disaster  – Caused by Arm Hair?
  67. Sept. 18 – Celltrion Shocked by Insider Trading Charges
  68. Sept. 18 – Chinagate Scandal Now Implicating Alcon
  69. Sept. 16 – Oops, They’re in Trouble Again – Ranbaxy Labs Import Alert
  70. Sept. 16 – Pfizer Screw Up Leads to Nerve Gas Antidote Shortage
  71. Sept. 13 – Prescription Fish Oil Pill Stink
  72. Sept. 12 – Ensuring that Ingredient Supplier Audits Are Free of Bias
  73. Sept. 12 – Major R&D Changes Planned at Merck
  74. Sept. 11 – 5 Critical Tips to Solve an FDA Warning Letter Crisis
  75. Sept. 10 – FDA Announces New Warnings on Opioid Painkillers
  76. Sept. 10 – Reminders About FDA Requirements for Qualifying Vendors
  77. Sept. 10 – Three Simple FDA CAPA Tips to Ensure Compliance
  78. Sept. 9 – No Need to Validate the Software in Design and Development? Wrong!
  79. Sept. 9 – Most Common FDA 483 Violations for Medical Devices
  80. Sept. 5 – New FDA Warning Letters Point Out CAPA Flaws
  81. Sept. 5 – FDA cGMP Inspections Getting More Intense in US
  82. Sept. 3 – Latest Trends in cGMP Compliance
  83. Sept. 3 – GSK Bribery in China Coordinated at High Level?
  84. Aug. 30 – 6 Tips to Avoid 510(k) Submission Delays
  85. Aug. 29 – Two More India API Companies Earn FDA Warning Letters
  86. Aug. 29 – FDA Warnings Going Social
  87. Aug. 28 – Tips and Thoughts on Critical Process Cleaning Procedures
  88. Aug. 28 – FDA – 70% of Dietary Supplement Companies Violate cGMPs
  89. Aug. 27 – Warning Letter Trend Suggests Crackdown on Contract Manufacturing, Using Park Doctrine
  90. Aug. 27 – Lonza Cutting Jobs at Massachusetts Plant by End of 2013
  91. Aug. 26 – Fresenius Slammed With Warning Letter for Complaint Handling
  92. Aug. 26 – No Device Complaints – No Problems? Think Again
  93. Aug. 22 – Tips to Qualify Your Pharmaceutical Ingredient Suppliers
  94. Aug. 22 – Scandal Widens: Ex Lilly Manager Says Docs Paid $5 Million
  95. Aug. 22 – Top 10 Reasons Deviation Investigation Systems Fail
  96. Aug. 20- Is Troubled J&J Tylenol Plant Ready to Reopen?
  97. Aug. 20 – FDA Inspections Held Up by Visa Delays in China
  98. Aug. 19 – Should a Prostate Drug Be Used to Stop Cancer?
  99. Aug. 19 – Boehringer Ingelheim Closes WV Plant, Cutting 240 Jobs
  100. Aug. 15 – FDA Looks Closely at Opioid APIs
  101. Aug. 15 – Could FDA Have Stopped the Bacterial Infections Traced to NECC?
  102. Aug. 14 – FDA Approves Two New, Promising HIV Drugs
  103. Aug. 14- China Bribery Scandal Now Engulfs Novartis
  104. Aug. 13 – Source: West Ward Pharmaceutical Giving Bonuses Only to Non-Union Workers?
  105. Aug. 13 – Acorda Therapeutics Slammed With New Warning Letter for Ads
  106. Aug. 7 – DCGI in India to Review cGMP Compliance for Ranbaxy Facilities
  107. Aug. 7 – FDA Orders Acetaminophen Warning
  108. Aug. 6 – Serious Novartis Scandal Causes Japan to Mull Penalties for False Data
  109. Aug. 6 – TV Ads for Statins Cause Overdiagnosis and Prescribing
  110. Aug. 5 – FDA Blasts Cispharma in Warning Letter for Poor Inury Investigation
  111. Aug. 5 - AMRI Hit With Another 483 in Burlington MA
  112. Aug. 2 – Valeant CEO Ripped by New York Politicians for Moving HQ
  113. July 31 – Lower Irish Tax Rate Closes Perrigo/Elan Deal
  114. July 31 – Valeant Chops 2850 Workers After Recent Bausch and Lomb Deal
  115. July 31 – McKesson Plans to Fight Clawback Policy
  116. July 29 – EMA Says No Pancreatic Cancer Risk With Diabetes Drugs
  117. July  29 – Chinese Authorities Release More Sordid Glaxo Scandal Details
  118. July 26 – Glaxo Telling Muddled Stories on Chinese Bribery Trainwreck
  119. July 26 – IMS Health Accused of Eliminating Competition to Gain Monopoly
  120. July 25 – PhRMA Ranked as Top Lobbying Group in DC
  121. July 24 – The Glaxo China Trainwreck – Bribes, Hidden Study Results and More
  122. July 24 – Urine Puddles and Destroyed Records – FDA Hits Wockhardt Hard in Latest Warning Letter
  123. July 23 – Mallinckrodt Shells Out $3.5 Million to Settle Kickback Probe
  124. July 23 – Damage Spreads for Glaxo in China Bribery Scandal – Execs Oversaw Bribes
  125. July 22 – Eli Lilly Enacts Pay Raise Freeze for Employees
  126. July 22 – Wockhardt Plant in India Gets FDA Warning Letter
  127. July 19 – Bristol Myers Squibb Adding 579 Jobs in Tampa, Florida
  128. July 19 – Glaxo Execs Forced to Stay in China Over Bribe Accusations
  129. July 18 – Feds Suspect Novartis of Shady Marketing of Gilenya MS Pill
  130. July 17 – J&J Pays $23 Million to End Recall Lawsuit
  131. July 17 – FDA Issues Guidance on How to Avoid Inspection Problems
  132. July 17 – FDA Sends Warning Letter to Genentech Trial Investigator
  133. July 16 – Fraud Charge on Danish Doc for Payments from Drugmakers
  134. July 16 – 5 Ways to Avoid cGMP Problems with FDA
  135. July 15 – GSK Now the Leader in Chinese Bribery Scandal
  136. July 15 – Fake Avastin Salesman Ducks Jail Time
  137. July 12 – Lawyer Fights with FDA on J&J Risperdal Court Papers
  138. July 12 – China Arrests Dozens of Glaxo Employees in Epic Scandal
  139. July 11 – Hikma Hit With Warning Letter, Closes West Ward Plant for Fixes
  140. July 11 – GSK Executives in China Admit to Bribery, Tax Crimes
  141. July 10 – Frensenius API Plant Gets FDA Warning Letter
  142. July 10 – Europe Devises Water Pollution Watch List for Drugs
  143. July 10 – MHRA Bans Wockhardt from Making Drugs for European Market
  144. July 9 – FDA Planning Big Changes to Generic Warning Labels
  145. July 9 – Merck Gets Big Preemption Win
  146. July 8 – GSK Investigates Illegal Sales Practices for Botox
  147. July 8 – Ranbaxy Plans to Chop Hundreds of Jobs
  148. July 5 – FDA Sends Nasty Warning Letter to Honey Company
  149. July 5 – SEC Charges Insider Trading at Onyx Pharmaceuticals
  150. July 3 – Ranbaxy Drugs Are Declared Safe in Australia
  151. July 3 – Where is Big Pharma Hiring These Days?
  152. July 2 – FDA Inspections Set to Spike in India
  153. July 2 – FDA Rejects New Merck Sleeping Pill – For Time Being
  154. July 1 – Writing Effective SOPs for Pharma
  155. July 1 – Glaxo Employees Held in China on Graft Probe
  156. June 28 – Ensuring Effective SOPs in the Pharmaceutical Industry
  157. June 28 – FDA Drops the Hammer – 1677 Online Pharmacies Closed
  158. June 27 – Medical Device CEO Held Hostage in China
  159. June 26 – Intuitive Surgical Blasted in 483 for Not Reporting Warning
  160. June 26 – India Cancels J&J Plant License
  161. June 26 – DTC Drug Ad Text Is Too Hard to Read, Group Says
  162. June 25 – Ranbaxy Slammed With Another Nasty 483
  163. June 25 – Indian Court Tosses Criminal Suit for Ranbaxy Labs
  164. June 24 – FDA Cracking Down Harder on Indian cGMP Problems
  165. June 24 – Maine Legislature Votes to Allow Drug Imports from Foreign Pharmacies
  166. June 21 – Cephalon Reps Shown Trays of Cash to Promote Off Label Use
  167. June 21 – AMA Fights Fat and Boosts Pharma With Obesity Decision
  168. June 20 – China Blasts J&J Over Product Recalls
  169. June 20 – Eli Lilly Fighting Scam Artists Over Illegal Name Use
  170. June 19 – USSC Says that Pharma Companies Can Be Sued for Pay to Delay Deals
  171. June 19 – FDA Probes Deaths of Zyprexa Patients
  172. June 18 – FDA Inspectors Find Mess During Audit of TN Pharmacy
  173. June 18 – Japan Terminates Recommendations for HPV Vaccines
  174. June 17 – FDA Issues Medical Device Alert Over Malware
  175. June 17 – FDA Zeroes in on Patient-Focused Drug Development
  176. June 17 – Major Operations Overhaul at Merck by New R&D Exec
  177. June 14 – New Warning Letter Shows FDA Moving Beyond Basic cGMP Issues
  178. June 14 – Major Insurer Stops Coverage for Compounded Drugs
  179. June 13 – Download Free FDA Digest Sample Newsletter Today!
  180. June 13 – Why Are Most Americans Ducking Clinical Trials?
  181. June 13 – Pfizer and Teva Reach $2 Billion Deal on Patent Spat
  182. June 13 – More Glaxo Scandals in China – Bribing Doctors to Prescribe Meds
  183. June 12 – Glaxo Fires Exec For Faked Data in Scientific Paper
  184. June 12 – Walgreens Pays $80 Million for Controlled Substances Act Violations
  185. June 11 – Baxter Healthcare Receives Especially Nasty Warning Letter
  186. June 11 – GSK HQ Is a 10×10 Foot Office in….Delaware
  187. June 11 – Ex-Bristol Myers Exec Pleads Guilty to Insider Trading
  188. June 7 – Past Expertbriefings.com Webinars – Download Today!
  189. June 7 – When a Medical Device Company Crosses the Line Into Crime
  190. June 7 – Bear Bile Drugs in China Cause Outcry
  191. June 7 – FDA Panel Votes to Ease Up Avandia Restrictions
  192. June 6 – FDA Ordered to Make Plan B Pills Available
  193. June 6 – GSK Probes Allegedly Fake Clinical Trial Data Produced by Employees
  194. June 5 – Should FDA Be Holding the Avandia Advisory Committee Meeting?
  195. June 5 – Novartis Manufacturing Plant Slammed With Warning Letter
  196. June 4 – J&J Recall Nightmare – 32 Million Boxes of Contraceptives in 43 Countries
  197. June 4 – What Should FDA Do About Ibuprofen?
  198. June 3 – FDA Scientists Do Not Find Misconduct in Avandia Trial Data
  199. June 3- Lundbeck Slapped with Big Fine in EU for Pay to Delay Deals
  200. June 3 – How Well Do Drugmakers Understand Informed Consent?
  201. May 31 – Hospira Keeps Getting Warning Letters – Is a Consent Decree Coming?
  202. May 31 – Rogue FDA Reviewer Insists that ARB Heart Drugs Cause Cancer
  203. May 30 – Major cGMP Problems Lead to Drug Shortages
  204. May 30 – AbbVie Chops 100 Scientist Jobs
  205. May 30 – Age Discrimination Accusations at Shire
  206. May 29 – FDA Releases Draft Guidance on Contract Manufacturing
  207. May 29 – New Compounding Pharmacy Scandal in TN
  208. May 29 – Greed and Post-Marketing Requirements Lead to Trouble for Shionogi
  209. May 28 – Forest Lab CEO Retires, But Feds Issue Subpoena
  210. May 28 – Tips to Vacuum Your Cleanroom
  211. May 28 – Ranbaxy Ignored Consultant Warnings About Major cGMP Problems
  212. May 27 – FDA Data Reveals More Warning Letters to Medical Device Companies
  213. May 27 – FDA Slams Boehringer-Ingelheim with Warning Letter
  214. May 27 – Impax Brings In Specialists to Fix cGMP Problems
  215. May 24 – Ranbaxy Labs Blasts Salvo at Daiichi Sankyo
  216. May 24 – Novartis Admits It Did Wrong in Diovan Trials
  217. May 23 – Hidden FDA Agenda for Avandia Meeting?
  218. May 23 – J&J Tylenol Recall Disaster in Brazil
  219. May 23 – Readying for a US FDA Inspection
  220. May 22- FDA Inspectors Give 483s to 7 of 10 Dietary Supplement Companies
  221. May 22 – How to Create and Staff Your FDA Inspection War Room
  222. May 22 – Major Shake Up at Boehringer After Warning Letter Disaster
  223. May 21 – J&J Soul Searching – Help Us With Our Credo
  224. May 21 – FDA Set to Regulate Fecal Transplants
  225. May 21 – Actavis Departs to Ireland for Lower Taxes
  226. May 20 – Bristol Myers Hit With Fine for Monkey Deaths
  227. May 20 – Pharmaceutical Cargo Thefts on the Rise
  228. May 20 – Another Risperdal Lawsuit Slams J&J
  229. May 20 – Serious Drug Recalls on the Rise
  230. May 16 – FDA Slams Hospira With Another Warning Letter
  231. May 16 – Court Tells FDA That FSMA Deadlines Are Required
  232. May 16 – How Ranbaxy Tried to Screw FDA
  233. May 16 – Criminal Charges on J&J in South Korea Tylenol Case
  234. May 15 – How to Improve Your CAPA System
  235. May 15 – Watch Out for What You ‘Like’ – FDA Is Watching Your Facebook Page
  236. May 15 – Recent FDA Warning Letter Lessons Show FDA Is Watching Facebook
  237. May 15 – More Pharma Jobs Get the Axe
  238. May 14 – How to Keep Up With Medical Device Demand and Keep Quality High
  239. May 14 – Ranbaxy Production Scandal Costs $500 Million
  240. May 14 – Why Did Senior FDA Official Leave Agency? Congressional Probe Begins
  241. May 13 – New FDA Warning Letter Shows Web Content Is Extension of Labeling
  242. May 13 – Fired CRO Exec Says Firm Was Tracking Sexual Orientation of Hires
  243. May 13 – 5 Screw Ups That Will Delay Your FDA 510(K) Approval
  244. May 13 – Novartis Playing Catch Up on Vet Drug Production Woes At Nebraska Plant
  245. May 13 – Essential Tips for New FDA 510(K) Refuse to Accept Policy
  246. May 8 – Bayer Warned – Pull False Vitamin Claim or We’ll Sue
  247. May 8 – Eli Lilly Chops Hundreds More Sales Rep Jobs
  248. May 8 – More J&J Uproar: Employees Sue for Age Discrimination
  249. May 7 – Update – Tanning Bed Ban for Teens Not Off the Table, FDA Warns
  250. May 7 – FDA Plans to Reclassify Tanning Beds as Class II Medical Devices
  251. May 7 – Is Selling Viagra Direct Online a Good Idea?
  252. May 7 – Teva Regrets Canning Worker With Brain Tumor
  253. May 6 - Absolute Worst FDA Warning Letter Responses
  254. May 6 – FDA Ponders – Is Tricolsan Safe?
  255. May 6 – J&J Stops Tylenol Production in South Korea
  256. May 6 – Caffeinated Gun Causes New FDA Investigation
  257. May 3 – Scandal Over Conflict of Interest for Novartis Trial
  258. May 3 – Essential Tips for Bulletproof cGMP Quality Agreements
  259. May 2 – Why So Few FDA Warning Letters?
  260. May 2 – Did Judge Go Too Far on Plan B Pill?
  261. May 2 – Novartis Dumps OTC Drugs Produced at 483-Plagued NE Plant
  262. May 2- FDA Wants Help on Think Tank for Opioid Trials
  263. May 2 – Got MS? Have a Free Lunch on Novartis
  264. May 1 – Raised Eyebrow Alert – High Level FDAer Leaving for Mylan
  265. May 1 – FDA Deputy Commissioner Moves on to Mylan
  266. May 1 – FDA Releases Ugly Novartis 483 for Lincoln NE Plant
  267. April 30 – FDA Allows Access to Plan B for 15 Year Olds
  268. April 30 – Give Attention to Equipment Calibration Certificates
  269. April 30 – Free FDA Compliance and cGMP Reports
  270. April 30 – 5 Tips for Rock Solid Supplier Controls
  271. April 30 – FDA and Allergan Warn About Fake Botox from Overseas
  272. April 30 – More Counterfeit Drugs Pop Up – What to Do?
  273. April 29 – How to Optimize Your Quality System to Ensure FDA and ISO Compliance
  274. April 29 – 3 More Tips for Excellent cGMP Plant Design
  275. April 29 – The Clock Is Ticking Part 2 – 15 Days to Respond to 483
  276. April 29 – Hooters and Fishing Trips for Docs – Has Novartis Violated Corporate Integrity Agreement?
  277. April 29 – Senate Bill Gains Major Support to Boost FDA Muscle on Drug Compounders
  278. April 25 – The Clock is Ticking – Responding to FDA 483 in 15 Days
  279. April 25 – FDA Raids Cancer Clinic, Confiscates Laetrile
  280. April 25 – Salesman for Fake Avastin Pleads Guilty to Felony
  281. April 25 – FDA Counterfeit Device Detector Targets Fake Malaria Drugs
  282. April 25 – Monkey Abuse Scandal – Harvard Shutting Down Primate Research Center
  283. April 24 – Effective Project Management for Developing Medical Devices
  284. April 24 – GMP Problems Result in 300 Jobs Chopped at Novartis Plant
  285. April 24 – More Evidence of Link Between Autism and Antidepressants
  286. April 24 – Novartis Sued by Federal Government for Massive Kickback Scheme
  287. April 23 – FDA Mulls Petition to Protect Patents for Biologic Medications
  288. April 23 – FDA Recognizes OxyContin Abuse with New Reformulation
  289. April 23 – Congress Preparing Legislation to Improve Pharmaceutical Supply Chain
  290. April 23 – FDA Blasts Teva for Overblown Marketing Materials
  291. April 22 – 3 Best Practices for Strong cGMP Plant Design
  292. April 22 – More Drug Compounding Recalls for Bacteria in Vials of Sterile Product
  293. April 22 – FDA Wants More Regulatory Authority to Regulate Drug Compounding
  294. April 22 – Aptuit Employee Busted and Jailed for Clinical Trial Data Scams
  295. April 22 – Essential cGMP Quality Tips for Senior Managers
  296. April 19 – The Risks of an FDA Import Alert
  297. April 19 – FDA Opts for Public Safety Over Pain Med Access
  298. April 18 – 5 Lab Calibration Tips – Stay Ahead of the cGMP FDA Inspector
  299. April 18 – Contract Manufacturing Organization Hit with cGMP Warning Letter
  300. April 18 – Revision of Clinical Trial Ethics in Helsinki Declaration
  301. April 18 – FDA Guidance on Quality Agreements for CMOs Much Needed
  302. April 17 – 5 Crucial Tips to Deal With an FDA Warning Letter
  303. April 17 – Perfect OOS Results Will Make FDA Auditor Nervous, and Other cGMP Inspection Issues
  304. April 17 – And the #1 cGMP 483 Observation for 2012 Is…
  305. April 16 – cGMP Consultant Paid $1000 a Day for Assembling Binders?
  306. April 16 – Why You Need a Strong Relationship with Your CMO
  307. April 16 – Latest FDA cGMP Inspection Trends Highlighted at Recent Conference
  308. April 15 – Stability Testing a Common Problem in FDA Warning Letters
  309. April 15 – 21 CFR 211.194 – Tips for Laboratory Records cGMP Compliance for QC Labs
  310. April 15 – 21 CFR 820.198- Implementing Risk-Based Management in Handling Complaints
  311. April 13 – 21 CFR 820.198 – Avoiding Pitfalls in Your Complaint Handling Process
  312. April 12 – Setting up Your Bulletproof MDR Files, and How to Avoid Landmines
  313. April 12 – Understanding the Medical Device Reporting Regulations
  314. April 10 - Expert Recommendations for FDA eCopy Submission
  315. April 10 – Pfizer Hit with Warning Letter for Serious cGMP Manufacturing Problems
  316. April 9 – Does My FDA eCopy Submission Meet FDA Requirements?
  317. April 9 – eCTD Tips – Transitioning from Paper to Electronic Submissions
  318. April 8 – Kabco Pharma Consent Decree Lesson – Provide Complete Warning Letter Reponse to FDA
  319. April 8  – How to Stay Compliant with 21 CFR Part 11
  320. April 8 – You May Not Even Know You Are On Import Alert
  321. April 8 – 15 Simple Steps for cGMP-Compliant Quality Systems
  322. April 5 – How to Ensure FDA cGMP Compliance With Employees
  323. April 4 – cGMP Inspection Tip – Best and Worst FDA 483 Response Letters
  324. April 4 – The Urgent Danger of Repeat 483 Observations
  325. April 3- Bugs and More Bugs – an FDA cGMP Inspection Disaster
  326. April-3 FDA Not Really Hammering Pharma on Social Media, Report Finds
  327. April 3 – 3 Tips to Handle Non-PDF Files in Your FDA eCopy Submission
  328. April 2 – Bizarre – Cancer Research Compound Robbery
  329. 4 Tips for Pharma in Social Media From Former FDA Commissioner
  330. More Clarity Needed on FDA eSource Trial Data Draft Guidance
  331. Hospira Consent Decree Coming?
  332. FDA/Customs Country of Origin Confusion on Drugs
  333. cGMP Quality Agreement Tip – Remember Definitions!
  334. Beg for a Warning Letter and FDA Says, “Sure!”
  335. 7 Tips to Hire a Top cGMP Consultant
  336. Analysis: DEA Move Could Limit How Pharma Markets Heavy Painkillers
  337. Stringent PDF Requirements A Roadblock for FDA eCopy
  338. More Great FDA Inspection Tips (and One Unforgettable Quote from the FDA Compliance Director)
  339. Is GSK Pressure on FDA Influencing Hospira 483 Failures?
  340. Tips to Perform Your Next Laboratory Quality Audit
  341. FDA Inspection Close Up – Using Strong Process Mapping and Gap Analysis
  342. The Death of Paper – FDA eCopy
  343. PDF Problems Reported with FDA’s New eCopy Rule
  344. Former FDA Recall Chief – How to Design Your Recall Strategy
  345. More Tips to Survive Your FDA Clinical Inspection
  346. Danger! Legal Landmines in Your Company Records!
  347. Using Effective Process Mapping, Gap Analysis and SOP Review
  348. 5 Do’s and Don’ts for Your Next FDA Inspection
  349. Yes or No – Should You Shut Down Production During Your FDA Inspection?
  350. Choppy Road Ahead for Confusing eCopy Initiative
  351. Facebook Frisking Your FDA Auditor
  352. Like Candy at Easter – FDA Hands Out CAPA 483 Observations
  353. Industry Bafflement by CDRH eCopy Rule Continues; FDA Confused, as Well
  354. Why Is CDRH’s eCopy Confusing Everybody?
  355. Tip – Check Out Your Vendor Quality Before Signing the Deal
  356. Why You Have to Have a Quality Agreement with Your Contractor
  357. Avoid FDA – Move to Kansas :)
  358. Avoid a CAPA File Inspection Disaster
  359. How the Quality Manager Gets Fired aka the $100,000 FDA Compliance Mistake
  360. Don’t Put Your Pharma Company in LA?
  361. The Silent Treatment and Other Classic FDA Tricks
  362. Top FDA 483 Citations – Recent Data, Plus More 806 Enforcement

 

 


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